Table of Contents Chairman’s Message
2
About AMMI
4
Board of Directors
6
Membership
7
Full Members
8
Associate Members
12
Members’ Ac vi es
13
Government Affairs and Policy
17
Regulatory and Technical
23
Talent Development
26
News Highlights
30
AMMI Annual Report 2016
1
HIGHLIGHTS OF 2016 The Board is pleased to report that our Associa on is in good financial posi on.
Dear AMMI Members, On behalf of the Board of Directors, I am pleased to present to our members, the Associa on of Malaysian Medical Industries (AMMI) Annual Report for the year ending 31 December 2016. The medical device industry con nues to be an area of growth in Malaysia. AMMI members’ cumula ve investments amounted to RM5.09 billion in 2015, as compared to RM4.27 billion in 2014. The increase reflects investors’ confidence in the Medical Device Industry in Malaysia. According to AMMI’s survey, members’ collec ve exports in 2015 increased by 20% to reach RM8.3 billion, accoun ng for more than 50% of Malaysia’s total exports of medical devices of RM15.5 billion in 2015. The survey also recorded an outstanding average value-added ra o of 60% in manufacturing medical devices in Malaysia. A high percentage of about RM1.97 billion or 55% worth of raw materials and services were locally sourced from within Malaysia. AMMI members spent a total of RM45.0 million in research & development (R&D) ac vi es in 2015, propelling a gradual shi towards higher-value added and innova ve medical devices. All this is good news for the medical device industry and its stakeholders as this reinforces the country’s standing as an ideal hub for medical device manufacturing.
2 AMMI Annual Report 2016
In 2016, six (6) new companies joined AMMI, bringing the total number of members to sixty-two (62). They are Boston Scien fic Medical Device (Malaysia) Sdn. Bhd., Cochlear Malaysia Sdn. Bhd., Engineered Medical Systems Malaysia Sdn. Bhd., Orthomedic Innova ons Sdn. Bhd., Owen Mumford Sdn. Bhd. and Plas k STC Sdn. Bhd. We hope to see more medical device companies joining so that AMMI can truly be the voice of the medical device manufacturing industry in Malaysia. AMMI con nues to foster a good working rela onship with various government ministries and agencies. In July this year, AMMI had an exclusive dialogue session with the Malaysian Investment Development Authority (MIDA) and jointly launched the AMMI Medical Device Industry Outlook Report 2016. The report is recognised as a good reference highligh ng the status of the industry in Malaysia. It also provides insights on the outlook and future prospects of the industry in general. AMMI has been appointed the chair of MIDA’s Medical Device Sub-Industry Working Group under its Industry Skills Commi ee and is also a member of MIDA’s Medical Device Investment Advisory Panel (MDIAP). The objec ve of the forma on of MDIAP is to strengthen the medical device manufacturing industry in Malaysia and to be er facilitate companies including SMEs to becoming strong players interna onally.
AMMI is also on the SME Corpora on Malaysia HIP (High Impact Programme):5 Medical Device Steering Commi ee. The objec ve of the commi ee is to assist medical companies in cer fica on and regula on support, marke ng strategy support, interna onal partner search, technology roadmap development and industry landscaping; and supply chain management. AMMI successfully organised 6 public training courses and trained 180 par cipants in 2016. We also organised 2 HR Forums and Networking mee ngs this year, in Penang and Kuala Lumpur. We are encouraged by the increase in par cipa on in the HR forums and hope more members will come forward to champion these forums, making them relevant and sustainable pla orms for HR professionals.
MAIN CHALLENGES … Besides fluctua on of currency, increase in labour cost and factors like natural gas price increase have accelerated the overall manufacturing cost. Shortage of skilled workforce and reten on of talent remain key challenges in the industry. Another major challenge is the limited access to the local public healthcare system for our industry players.
On behalf of the Board of Directors, I would like thank all those who have supported our Associa on. The Associa on’s role and its contribu on to the development of the medical devices industry is increasingly being recognised by government ministries and agencies such as Ministry of Interna onal Trade and Industry (MITI), Malaysian Investment Development Authority (MIDA), Malaysia External Trade Development Corpora on (MATRADE) and SME Corpora on. AMMI will no doubt work hard with our key stakeholders and engage key decision makers ensuring balanced policy advocacy. I would like to record my apprecia on to our members for their ac ve par cipa on at our mee ngs and events. I am thankful to the Board of Directors for their valuable contribu on, advice and ac ve engagement without which our Associa on would not have progressed this far. Finally, my grateful thanks to the staff of Medsociate Sdn Bhd, our Secretariat for rendering services professionally to the Associa on and to its members.
LOOKING AHEAD… Compe on from manufacturers in China, India and Vietnam will con nue to add pricing pressure to medical device manufacturers in Malaysia. Despite a weaker ringgit and other extraneous factors that have dampened the economic outlook of this country, AMMI member companies remain bullish about business prospects in 2017.
HITENDRA JOSHI Chairman December 31, 2016
AMMI Annual Report 2016
3
VISION “Establish Malaysia as the preferred global manufacturing loca on for medical technology.”
MISSION “Promote and strengthen best in class manufacturing opera ons in Malaysia by iden fying and promo ng appropriate processes, structures, policies and support required to facilitate manufacturing and opera onal excellence.”
Quick Stats Formed in 1989, the Associa on of Malaysian Medical Industries (AMMI), re p re s e n t s l e a d i n g m e d i c a l d e v i c e manufacturing companies in the medical technology industry in Malaysia. AMMI currently has 62 member companies and collec vely, they account for more than half of the total export revenue for “Made-inMalaysia” medical devices. AMMI MEMBERS SHARE A COMMON COMMITMENT TO QUALITY AND ARE REPUTABLE INTERNATIONAL AND LOCAL FIRMS THAT STRICTLY ADHERE TO THE QUALITY MANAGEMENT SYSTEM CODE LAID DOWN BY GOVERNMENTAL AGENCIES. AMMI companies con nue to be the growth base of the medical device industry in Malaysia and consist of three main types of industry players: manufacturers; suppliers of raw materials and services to the medical devices manufacturing companies; and importers and exporters of medical devices, all of whom employ a sizable workforce in their produc on facili es.
4 AMMI Annual Report 2016
62 Members Collectively accounted for over
51%
Export for Medical Devices
Collective export value in 2015
8.3billion
RM
Employ more than
31,000
Knowledge based workforce
AMMI Annual Report 2016
5
CHAIRMAN MR. HITENDRA JOSHI B. Braun Medical Industries Sdn. Bhd.
VICE-CHAIRMAN MR LIM BEE LEONG Bemis Asia Pacific Sdn. Bhd.
VICE-CHAIRMAN MR JOHN WARD SteriPack Asia Sdn. Bhd.
SECRETARY MR CHRISTOPHE MARQUE Stereo Sdn. Bhd.
TREASURER MR CHIN HOCK MENG St. Jude Medical Opera ons (M) Sdn. Bhd. St. Jude Medical is now Abbo
DIRECTOR
DIRECTOR
DIRECTOR
DIRECTOR
MR SUWIT TUNLAYADECHANONT
MR YAP KEE KEONG
DATO’ DR HAMINNUDDIN HJ. ABDUL HAMID
MS ONG YEAN TING
Synergy Sterilisa on (M) Sdn. Bhd. (now part of STERIS)
6 AMMI Annual Report 2016
Texchem Life Sciences Sdn. Bhd.
Ideal Healthcare Sdn. Bhd.
Johnson & Johnson Sdn. Bhd. (un l Sept 2016)
COMMITTEE LEADER: Ÿ
Mr John Ward (SteriPack Asia Sdn. Bhd.)
MEMBERS:
UPGRADED TO FULL MEMBERS:
Mr Lim Bee Leong (Bemis Asia Pacific Sdn. Bhd.) Mr Suwit Tunlayadechanont (Synergy Sterilisa on (M) Sdn. Bhd., now part of STERIS) Ÿ Mr Christophe Marque (Stereo Sdn. Bhd.) Ÿ Mr Kevin Wong (Prent Malaysia Sdn. Bhd.)
1. 2. 3. 4. 5.
Ÿ Ÿ
Diptech Industries Sdn. Bhd. KLS Mar n Malaysia Sdn. Bhd. Nitritex (M) Sdn. Bhd. Paramit Malaysia Sdn. Bhd. Sanmina-SCI System (Malaysia) Sdn. Bhd.
NEW MEMBERS : Boston Scien fic Medical Device (Malaysia) Sdn. Bhd. Established in 1979, the US-based company specialises in products and technologies used to diagnose or treat a wide range of medical condi ons, including heart, diges ve, pulmonary, vascular, urological, pelvic health, and chronic pain condi ons. Their new facility on the 20-acre site in the Batu Kawan Industrial Park in Penang is earmarked to begin opera ons in the fourth quarter of 2017. Cochlear Malaysia Sdn. Bhd. Founded in 1981, Cochlear is an Australian based medical device company that designs, manufactures and supplies the Nucleus cochlear implant, the Hybrid electro-acous c implant and the Baha bone conduc on implant. Incorporated in 2010, Cochlear Malaysia is comprised of a global service centre which provides global service & repair of sound processors and Baha, global IT services and technical support, corporate shared services as well as procurement support. Engineered Medical Systems Malaysia Sdn. Bhd. Established in 1985, Engineered Medical Systems Inc. is a medical device manufacturer in Indianapolis, Indiana. Its second plant is located in Penang, Malaysia. EMS specialises in CO2 Indicator, heat and moisture exchanger/filter, and endotraceal tubes. Orthomedic Innova ons Sdn. Bhd. Established in 2008, Orthomedic is one of the leading orthopaedic implants and instruments manufacturer in Malaysia specialising in the trauma locking pla ng system. Owen Mumford Sdn. Bhd. Established in 1952, Owen Mumford is a global industry leader in medical device design and manufacturing. The company recently set up a new manufacturing facility in Johor, Malaysia to serve current and future customers in the region as well as develop new opportuni es. Owen Mumford develop pioneering medical products under its own brand as well as custom device solu ons for the world’s leading pharmaceu cal and diagnos c companies. Plas k STC Sdn. Bhd. Established in 1988, Plas k STC is part of Kumpulan H & L High-Tech located in Selangor. The company specialises in plas c injec on moulding services, plas c injec on mould fabrica on and precision engineering machining parts. It has a Clean Room of class 8 for plas c moulding medical parts. Plas k is UL approved and is a member of UN Global Compact. AMMI Annual Report 2016
7
FULL MEMBERS
DETAILS
1.
3M Malaysia Sdn. Bhd. Level 8, Block F, Oasis Square, No.2, Jalan PJU1A/7A, Ara Damansara, 47301 Petaling Jaya, Selangor, Malaysia. Tel : 603-7884 2888 Fax : 603-7884 2902
TECHNOLOGY APPLIED
Ÿ
Sterilisa on Technology Others
Ÿ
Others
2.
Ain Medicare Sdn. Bhd. Jalan 6/44, Kawasan Perindustrian Pengkalan Chepa 2, Kota Bharu 16100, Kelantan, Malaysia. Tel : 609-7743 388 Fax : 609-7742 205
Ÿ
3.
Allen Healthcare Products (M) Sdn. Bhd. 17, Lorong Nagasari 2, Taman Nagasari, 13600, Perai, Penang, Malaysia. Tel: 604-3901168 Fax: 604-3995770
In-Vitro Diagnos c Technology Plas c Technology
4.
Ambu Sdn. Bhd . Lot 69B , Lintang Bayan Lepas 6, Phase IV, 11900 Penang, Malaysia. Tel: 604-252 9000 Fax: 604-644 8932
5.
Ansell Global Trading Center (Malaysia) Sdn. Bhd. Prima 6, Prima Avenue, Block 3512, Jalan Teknokrat 6, 63000 Cyberjaya, Malaysia. Tel : 603-8310 6688 Fax: 603-8318 6699
6.
APS Medical Sdn. Bhd. No. 28-32, Jalan Teluk Batu 36/2, Batu 4 ½ , Jalan Kebun, Seksyen 36, 40470 Shah Alam, Selangor, Malaysia. Tel: 603-5162 2618 Fax: 603-5162 2619
Ÿ
Ÿ
Ÿ Ÿ
Ÿ Ÿ
Ÿ Ÿ Ÿ
Electro-Mechanical Medical Technology Others
Latex and Dipping Technology Sterilisa on Technology Plas c Technology Packaging Technology Sterilisa on Technology
Ÿ
7.
Bard Sdn. Bhd. Lot 57C, Lorong Perusahaan 5, Kulim Industrial Estate, 09000 Kulim, Kedah, Malaysia. Tel: 604 – 4801300 Fax: 604 – 4891737
Latex and Dipping Technology
8.
B Braun Medical Industries Sdn. Bhd. Bayan Lepas Free Industrial Zone, P O Box 880, 10810 Penang, Malaysia. Tel: 604-632 3100 Fax: 604-643 3750
Ÿ Ÿ
Plas c Technology Metal Technology
Ÿ
9.
Bemis Asia Pacific Sdn. Bhd. Lot 823, Jalan Subang 5, Taman Perindustrian Subang USJ 1, 47600 Subang Jaya, Selangor, Malaysia. Phone: 603- 8021 0998 Fax: 603- 8021 0000
Packaging Technology
Ÿ
10.
Cardinal Health (M) 211 Sdn. Bhd. Plot 74 A, Bayan Lepas Industrial Zone, Phase IV, Mk 12, Lintang Bayan Lepas 3, 11900 Bayan Lepas, Penang, Malaysia. Tel: 604-252 5200 Fax: 604-644 2311
Latex and Dipping Technology Packaging Technology
Ÿ
11.
Diptech Industries Sdn. Bhd. No.11 Jalan Angsana 1/3, Taman Perindustrian Angsana, 08000 Sungai Petani, Kedah, Malaysia. Tel: 604 -422 3688 Fax: 604 -424 0941
Latex and Dipping Technology
Ÿ
Plas c Technology
12.
Dispo-Med (Malaysia) Sdn. Bhd. 21, Jalan Teknologi 3/5A, Pusat Teknologi Sinar Damansara, Kota Damansara, 47810 Petaling Jaya, Selangor, Malaysia. Tel: 603-6730 4966/5466 Fax: 603-6143 6866
8 AMMI Annual Report 2016
Ÿ
FULL MEMBERS
DETAILS
TECHNOLOGY APPLIED
13.
DuPont Malaysia Sdn. Bhd. Level 7, Menara CIMB, Jalan Stesen Sentral 2 Kuala Lumpur Sentral, 50490 Kuala Lumpur, Malaysia. Tel: 603- 285 90700 Fax: 603-285 99079
14.
Epsilon Medical Devices Sdn. Bhd. Lot 5271, Jalan Perusahaan 3, Kamun ng Industrial Area 34600 Kamun ng, Perak, Malaysia. Tel : 605-8913158 Fax : 605-8911266
Ÿ
Others
15.
Fresenius Medical Care Produc on Sdn. Bhd. Lot 34618 PT29466, Bandar Enstek, Mukim Labu 71760 Bandar Enstek, Negeri Sembilan, Malaysia. Tel : 606-791 5334 Fax: 606-791 5336
16.
GMMI Sdn. Bhd. No. 12, Persiaran Industri Rapat 2, Kawasan Perindustrian Ringan Sri Rapat, 31350 Ipoh, Perak, Malaysia. Tel : 605- 3131 912 Fax : 605- 3131 913
Ÿ Ÿ
Plas c Technology Packaging Technology In Vitro Diagnos c Technology
Ÿ
Packaging Technology
Ÿ
•
Plas c Technology Others
Ÿ
17.
Haemone cs Malaysia Sdn. Bhd. PMT 727, Persiaran Cassia Selatan 1, Taman Perindustrian Batu Kawan, 14100 Simpang Ampat, Seberang Perai Selatan, Penang, Malaysia. Tel : 604- 503 5141
Ÿ Ÿ
Plas c Technology In Vitro Diagnos c Technology
Ÿ
18.
Hospitech Manufacturing Services Sdn. Bhd. Sub Lot, 1 Lot 6536, Batu 6, Jalan Bukit Kemuning, 40460 Shah Alam, Selangor, Malaysia Tel: 603-5122 5199 Fax: 603-5122 5204
Sterilisa on Technology
19.
Ideal Healthcare Sdn. Bhd. No. 70 & 71, Jalan Sungai Tukang 2/1, Kawasan Perusahaan Sungai Tukang, Sungai Petani, 08000 Kedah, Malaysia. Tel : 604 -422 7775 / 8775 Fax : 604- 422 6775
Ÿ Ÿ
Plas c Technology Services
20.
ITL Asia Pacific Sdn. Bhd. Plot 17B, Lorong Bemban 2, Bemban Industrial Estate, 31000, Batu Gajah Perak, Malaysia. Tel: 605-362 9988 Fax: 605-362 9966
Ÿ Ÿ Ÿ
Plas c Technology Metal Technology Others
Ÿ
21.
Johnson & Johnson Sdn. Bhd. Level 8, The Pinnacle, Persiaran Lagoon, Bandar Sunway, 46150, Petaling Jaya, Selangor, Malaysia Tel: 603-7661 4615 Fax: 603-7610 0519
In Vitro Diagnos c Technology Sterilisa on Technology Others
22.
KLS Mar n Malaysia Sdn. Bhd. Lorong IKS Juru 5, Taman Industri Ringan Juru, 14100 Simpang Ampat, Penang, Malaysia. Tel: 604 505 7838 Fax: 604 504 0654
23.
Lake Region Medical Sdn. Bhd. No. 91-B, Lebuhraya Kampung Jawa, 11900 Bayan Lepas, Penang, Malaysia. Tel: 604-810 1800 Fax: 604-643 1232
24.
Medipro Malaysia Sdn. Bhd. Lot 15, Lebuh Hisamuddin 3, Kaw. 20, Bandar Sultan Sulaiman, 42000 Port Klang, Selangor, Malaysia. Tel: 603-3176 3446 Fax: 603-3176 4229
Ÿ Ÿ Ÿ Ÿ
Metal Technology Electro-Mechanical Medical Technology
Ÿ Ÿ Ÿ
Metal Technology Electro-Mechanical Medical Technology Others
Ÿ
Others
AMMI Annual Report 2016
9
FULL MEMBERS
DETAILS
TECHNOLOGY APPLIED Ÿ
25.
Mediquip Sdn. Bhd. Padang La , Mukim Paya, P.O. Box 25, 01700 Kangar, Perlis, Malaysia. Tel: 604- 938 1411 ext: 222 Fax: 604-938 2150
Latex and Dipping Technology
Ÿ Ÿ
26.
Meditop Corpora on (M) Sdn. Bhd. Lot 3, Persiaran Usahawan, Taman iks, Seksyen 9, 43650 Bandar Baru Bangi, Selangor, Malaysia. Tel: 603-8925 8462 Fax: 603-8925 8468
Plas c Technology Electro-Mechanical Medical Technology Sterilisa on Technology
Ÿ
27.
MinTec-Sinagama, Malaysian Nuclear Agency Block 41, Malaysian Nuclear Agency, Bangi, 43000 Kajang,Selangor, Malaysia. Tel: 603-8925 0510 Fax: 603-8920 1099
Sterilisa on Technology
Ÿ
28.
Molnlycke Health Care Sdn. Bhd. (formerly known as Regent Hospital Products Sdn. Bhd.) Lot 9 Lorong Perusahaan 4, Kulim Industrial Estate, 09000 Kulim, Kedah, Malaysia. Tel : 604- 489 1819 Fax : 604-489 1220
Latex and Dipping Technology
Ÿ
Others
29.
Nitritex (M) Sdn. Bhd. 2 Jalan Jurunilai U1/20, Seksyen U1, Hicom Glenmarie Industrial Park, 40150 Shah Alam, Selangor, Malaysia. Tel: 603-5569 3857/ 3859 Fax: 603- 5569 3862
Ÿ
30.
Paramit Malaysia Sdn. Bhd. Plot 372, Penang Science Park, Lorong Perindustrian Bukit Minyak 21, Taman Perindustrian Bukit Minyak , 14100 Simpang Ampat, Seberang Perai Tengah, Penang, Malaysia. Tel : 604-6191000 Fax : 604-6191111
Electro -Mechanical Medical Technology Others
31.
Prent Malaysia Sdn. Bhd. PTD102587, Jalan Cyber 14, Senai Ind Park IV, 81400 Senai, Johor, Malaysia. Tel: 607- 599 7661 Fax: 607-599 7660
Ÿ Ÿ
Plas c Technology Packaging Technology
Ÿ
32.
Sanmina-SCI Systems (Malaysia) Sdn. Bhd. Plot 202, Lorong Perusahaan Maju 9, Bukit Tengah Industrial Estate, 13600 Perai, Penang Tel: 604-5081228 Fax: 604-5081233
Ÿ
Electro-Mechanical Medical Technology Services
Ÿ
Plas c Technology
33.
Sin Yong Guan Industries Sdn. Bhd. 8 Solok Rishah 2, Kawasan Perindustrian Silibin 30100 Ipoh, Perak, Malaysia. Tel: 605-526 7231 Fax: 605-526 8491
Ÿ
34.
Star Medik Sdn. Bhd. E081 Jalan 6, Cosmoplexs, Bandar Baru Salak Tinggi, 43900 Sepang, Selangor, Malaysia. Tel: 603-8706 5282/2934 Fax: 603-8706 5805
Electro-Mechanical Medical Technology Others
Ÿ
35.
Stereo Sdn. Bhd. 37, Lorong Sungai Puloh 1A/KU6, Taman Teknologi Gemilang, Kawasan Perindustrian Sungai Puloh, 41050 Klang Selangor, Malaysia. Tel : 603-3290 2263 Fax : 603-3290 2016
Sterilisa on Technology
Ÿ
Others
36.
SteriPack Asia Pacific Sdn. Bhd. PT119992, Jalan Canang Emas 8 , Telok Gong, 42000 Klang, Selangor, Malaysia. Tel : 603-3167 3596 Fax: 603-3167 3597
10 AMMI Annual Report 2016
Ÿ
Ÿ
Ÿ
FULL MEMBERS
DETAILS
TECHNOLOGY APPLIED
37.
Straits Orthopaedics (Mfg) Sdn. Bhd . 2 Lengkok Teluk Kumbar 1, Jalan Teluk Kumbar, 11920 Bayan Lepas, Penang, Malaysia Tel: 604-6494933 Fax: 604- 6494900
38.
St. Jude Medical Opera ons (Malaysia) Sdn. Bhd. St. Jude Medical is now Abbo Plot 102, Lebuhraya Kampung Jawa, Bayan Lepas Industrial Zone, 11900 Penang, Malaysia Tel: 604-810 1000 Fax: 604-810 1001
Ÿ
Others
39.
Symmetry Medical Malaysia Sdn. Bhd. Plot 80C, Kawasan Perusahaan Bayan Lepas, 11900 Bayan Lepas, Penang, Malaysia Tel : 604-645 6802 Fax : 604-6445805
Ÿ
40.
Synergy Sterilisa on (M) Sdn. Bhd (now part of STERIS). Plot 203 Kuala Ke l Industrial Estate, 09300 Kuala Ke l, Kedah, Malaysia Tel: 604-415 2111 Fax: 604-415 2121
Sterilisa on Technology
Ÿ
41.
Teleflex Medical Sdn. Bhd. Lot No PT2577, Jalan Perusahaan 4, 34600 Kamun ng, Perak, Malaysia Tel : 605-891 5111 Fax : 605-891 2699
Ÿ
Latex and Dipping Technology Plas c Technology
42.
Texchem Life Sciences Sdn. Bhd . Lot 3, Jalan P/6, Kawasan Perindustrian Bangi, No. 2, Bandar Baru Bangi, 43650, Selangor, Malaysia Tel : 603-8925 0370 Fax : 603-8925 0317
Ÿ Ÿ
Plas c Technology Others
Ÿ
43.
Top Glove Sdn. Bhd . Lot 4968, Bt 6 Jalan Teratai,Off Jalan Meru 41050 Klang, Selangor, Malaysia Tel: 603-3392 1992/1905 Fax: 603-3392 1291/8410
Latex and Dipping Technology
Ÿ
Plas c Technology
44.
Unomedical Sdn. Bhd. Bakar Arang Industrial Estate, 08000 Sungai Petani, Kedah, Malaysia Tel: 604-4212881 Fax: 604-4215920
45.
UWC Healthcare Mfg (M) Sdn. Bhd. 987, Jalan Perindustrian Bukit Minyak, Mukim 13, Kawasan Perindustrian Bukit Minyak, 14000 Bukit Mertajam, Penang , Malaysia Tel: 604-5078086 Fax: 604-5079298
Ÿ Ÿ Ÿ Ÿ
Metal Technology Plas c Technology Furniture/ Hospital Hardware Technology Others
Ÿ
Others
46.
Vigilenz Medical Devices Sdn. Bhd. No. 308 b, Jalan Perindustrian Bukit Minyak 18, Penang Science Park, 14100 Penang, Malaysia Tel: 604-5023 501/2 Fax: 604-5023 503
Ÿ
Others
47.
Worldwide Medivest Sdn. Bhd. No. 2, Jalan Karyawan 4/KU7, Lorong Sg Puloh, Taman Kapar Bestari, Kapar 42200, Selangor, Malaysia Tel: 603 – 3291 2625 Fax: 603 – 3291 2725
Ÿ
Plas c Technology
48.
Zeito Plas cs Components Sdn. Bhd. Lot 19-6,Bersatu Industrial Complex, Jalan CJ1/1, Cheras Jaya, 43200 Cheras, Selangor, Malaysia Tel : 603-9074 9177 Fax : 603-9074 9096
Ÿ
Metal Technology
Ÿ
Electro-Mechanical Medical Technology
AMMI Annual Report 2016
11
ASSOCIATE MEMBERS
DETAILS
TECHNOLOGY APPLIED
1.
Becton Dickinson Sdn. Bhd. Unit 24, LG 5 (Execu ve Wing), Hotel Equatorial Penang, 1 Jalan Bukit Jambul, 11900 Bayan Lepas, Penang, Malaysia. Tel: 604 640 5688 Fax: 604 640 5686
Ÿ Ÿ
Metal Technology Others
Ÿ
2.
BillerudKorsnäs AB C/O: Lot D12-11, Mu ara Oriental Condo, Jalan BM 1/8, Taman Bukit Mayang Emas, 47301 Petaling Jaya, Malaysia. Tel : 603 7806 1219 Fax : 603 7806 1219
Packaging Technology
Ÿ
Others
3.
Boston Scien fic Medical Device (Malaysia) Sdn. Bhd. Penang SME Centre, Plot 105 Hilir Sungai Kluang 5, Bayan Lepas Industrial Park, 11900 Bayan Lepas, Penang, Malaysia. Tel: 604-6133421 Fax: 604-6133401
Ÿ
4.
Cochlear Malaysia Sdn. Bhd. Unit UG1, Upper Ground Floor, Ver cal Podium, Avenue 3, Bangsar South, No.8 Jalan Kerinchi, 59200 Kuala Lumpur, Malaysia. Tel : 603 -22823839 Fax : 603-22823839
Ÿ Ÿ Ÿ Ÿ
Electro-Mechanical Medical Technology Packaging Technology Plas c Technology Sterilisa on Technology Services
Ÿ
Plas c Technology
5.
Engineered Medical Systems Malaysia Sdn. Bhd. 1114 Jalan Perindustrian Bukit Minyak 18, Penang Science Park, 14100 Simpang Ampat, Penang, Malaysia. Tel: 604 504 1252 Fax: 604 504 1253
Ÿ
Services
6.
MIRA Medsource (Malaysia) Sdn. Bhd. 35, 1st Floor, Jalan Todak 6, Pusat Bandar Sunway Perdana, 13700 Seberang Jaya, Penang, Malaysia. Tel: 604-383 8025 Hp: 6012-428 2311 Fax: 604-383 1845
Ÿ
Others
7.
Orthomedic Innova ons Sdn. Bhd. 188-D, Jalan Sultan Azlan Shah Sungai Tiram, 11900 Bayan Lepas, Penang, Malaysia. Tel: 604-644 5139 Fax: 604-6449139
Ÿ
8.
Owen Mumford Sdn. Bhd. No. 21, Jalan Bioteknologi 3, Kawasan Perindustrian SiLC Nusajaya, 79200 Johor, Malaysia. Tel : 607 -5539617 Fax : 607-5539617
Ÿ Ÿ
Packaging Technology Plas c Technology Others
9.
Plas c STC Sdn. Bhd. No 7 Jalan TSB 9, Taman Industri Sg Buloh 47000 Sungai Buloh, Selangor, Malaysia. Tel: 603-61575313 Fax: 603-61575318
Ÿ Ÿ
Plas c Technology Others
10.
Professional Tools & Dies Sdn. Bhd. 7118,Jalan Mak Mandin, Kawasan Perindustrian Mak Mandin, 13400 Bu erworth, Penang, Malaysia. Tel: 604-332 2335 Fax: 604-331 2337
Ÿ Ÿ
Plas c Technology Metal Technology
Ÿ
Others
11.
Sontara South Asia Sdn. Bhd. Level 15-1, 1 First Avenue, 2A, Dataran Bandar Utama Damansara, 47800 Petaling Jaya, Selangor, Malaysia. Tel: 603-7651 7396 Fax: 603-7651 7701
12.
Tako Asta c Technology Sdn. Bhd. 15 Jalan Kesuma 2/2, Bandar Tasik Kesuma, Beranang, 43700 Selangor, Malaysia. Tel : 603-87238843 Fax: 603-87238844
Ÿ Ÿ Ÿ
Packaging Technology Plas c Technology Services
13.
Terumo Malaysia Sdn. Bhd. Suite C405, 4th Floor, Center Tower, Wisma Consplant 1, No. 2, Jalan SS16/4, 47500 Subang Jaya, Selangor, Malaysia. Tel: 603-5880 8898 Fax: 603-5880 8891
Ÿ Ÿ
Others Services
14.
Varian Medical Systems (M) Sdn. Bhd. Suit B-15-5, Wisma Pantai, Plaza Pantai, No. 5, Jalan 4/83, Off Jalan Pantai Baru, 59200 Kuala Lumpur, Malaysia. Tel: 603-2282 9989 Fax: 603-2282 2866
Ÿ Ÿ
Metal Technology Others
12 AMMI Annual Report 2016
2-5 March: MIDA Exclusive Invita on to “Investment and Business Opportuni es Seminar on Medical Devices Sector” in Seoul, Korea Mr Jason Ng (UWC Healthcare Manufacturing Sdn.Bhd.) and Mr Chinniah Kalimuthu (APS Medical Sdn. Bhd.) par cipated in the ASEAN Korea Centre (AKC) -sponsored trip.
10 March: AMMI Q1 Progress Mee ng and Networking, Majes c Hotel Kuala Lumpur Thirty-eight members a ended the Q1 Progress Mee ng where they were updated on the upcoming events for 2016 and the AMMI 2020 Strategic Roadmap. This was followed by presenta ons on the 2016 Healthcare Industry Outlook by Ms Rhenu Bhuller (Frost and Sullivan) and the 2015 Investment Performance by Encik Ahmad Khairuddin (Execu ve Director, MIDA). AMMI Chairman, Mr Hitendra Joshi then presented a copy of the 2015 AMMI Annual Report to Encik Ahmad Khairuddin to signify the release of the report. A er the mee ng, members and guests adjourned to Smokehouse Lounge for networking cocktails.
23 June: AMMI Extraordinary Mee ng (EGM), 27th Annual General Mee ng (AGM) and Q2 Progress Mee ng, E&O Hotel, Penang Thirty-three members a ended the AMMI EGM, 27th AGM and Q2 Progress Mee ng. The AGM saw the re-elec on of Mr. Hitendra Joshi as AMMI Chairman; Mr. Yap Kee Keong and Ms Ong Yean Ting as AMMI Directors for the 2016-2018 term. Dato’ Dr Haminnuddin Hj Abd Hamid was also elected to the Board of Directors during the AGM. This was followed by the Q2 Progress Mee ng. A er the mee ng, members listened to presenta ons on Revised EU Regula ons by Ms Ong Yean Ting and Na onal Healthcare Internet of Things (ioT) by Dr Nor Azmi Alias and Dr Khoh Soo Beng from Collabora ve Research in Engineering, Science and Technology (CREST). Later, members and guests adjourned for networking cocktails.
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8 September: AMMI Q3 Progress Mee ng and Networking, Majes c Hotel, Kuala Lumpur
(L to R) Y.Bhg. Datuk Phang Ah Tong (Deputy CEO, MIDA), Y.Bhg. Datuk Zainal Amanshah (CEO, Invest KL), Y.Bhg. Datuk N. Rajendran (Deputy CEO, MIDA) and Mr N. Sangaran (Execu ve Director, MIDA) with Mr Hitendra Joshi (AMMI Chairman)
Thirty-one members a ended the Q3 Progress Mee ng. The session con nued with an exclusive Dialogue Session with representa ves from the Ministry of Health (MOH), Medical Device Authority (MDB), Malaysian Investment Development Authority (MIDA) and Ministry of Interna onal Trade and Industry (MITI). Members also were briefed on “Strategic Ini a ves under the HRDF Pool Fund” by the Human Resource Development Fund (HRDF) A er the mee ng, all adjourned to Smokehouse Lounge for networking cocktails. It was also a farewell cocktail for Ms Ong Yean Ting who had stepped down from the AMMI Board. Mr Hitendra Joshi presented Ms Ong with a token of apprecia on for her contribu ons to AMMI as Director as well as Leader of the Regulatory and Technical Commi ee.
15 December: AMMI Q4 Progress Mee ng and Networking, E&O Hotel, Penang Twenty-seven members a ended the Q4 Progress mee ng. Members took note of the round up of 2016 ac vi es and planned ac vi es for 2017. This was followed by presenta ons on “Industry Collabora on with USM and Public Private Research Network (PPRN)” by Associate Professor Dr Yeoh Fei Yee from University of Science Malaysia (USM) and “Mee ng the Challenges of a Growing Business through Management of Produc vity and Rewards" by Mr Michael Ng from Korn Ferry Hay Group. This was followed by networking cocktails.
14 AMMI Annual Report 2016
Le to right : Ma n Ng, David Koay, Maxx Lee, Christophe Marque, Dato’ Dr Haminnuddin, Lam Chee Hong, Tengku Muzzammil and Kiu Chee Kuen.
8 December: AMMI Annual Golf Tournament, Sultan Abdul Aziz Shah Golf and Country Club, Shah Alam Sixteen players par cipated in the fun and friendly tournament which pi ed “North vs South”. The North Team, captained by Dato‘ Dr Haminnuddin fought hard against the South Team and its Captain Daniel Lim to finally win by a few strokes. The North Team Captain took home the grand trophy for the year – and the South Team will be glad to challenge it for 2017! North Team : Dato’ Dr Haminnuddin Hj. Abdul Hamid (Ideal Healthcare Sdn. Bhd.), Mr Lam Chee Hong, Mr David Koay, Mr Kiu Chee Kuen and Tengku Muzzammil (B.Braun Medical Industries Sdn. Bhd.), Mr Maxx Lee (Professional Tools & Dies Sdn. Bhd.) and Mr Ma n Ng (UWC Healthcare Manufacturing Sdn. Bhd. ). South Team : Captain, Mr Daniel Lim (Sontara South Asia Sdn. Bhd.), Mr B.L Lim (Bemis Asia Pacific Sdn. Bhd.), Mr Andy Lee (Johnson & Johnson Sdn. Bhd.), Mr Ian Husband, Mr Ian Cheshire and Mr Zainol Razak (Owen Mumford Sdn. Bhd.), Mr John Ward (SteriPack Asia Pacific Sdn. Bhd.), Mr Christophe Marque (Stereo Sdn. Bhd. ) and Mr K.K.Tiu (Zeito Plas cs Sdn. Bhd.). A special note of thanks to Stereo Sdn Bhd for sponsoring the beau ful trophies.
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From le to right : Y.Bhg. Datuk Phang Ah Tong, Mr BL Lim, Y.Bhg Dato' Wan Hashim Wan Jusoh, Mr Christophe Marque, Mr John Ward, Y.Bhg. Datuk J.Jayasiri, Y.Bhg. Dato' Dr Haminnuddin, Mr Hitendra Joshi, Y.Bhg. Datuk N.Rajendran, Mr Jorg Schneewind, Y.Bhg Da n K. Talagavathi, Mr Suwit Tunlayadechanont, Mr Chin Hock Meng
8 December: AMMI Annual Dinner at Neo Tamarind, Kuala Lumpur Ninety members and guests a ended the networking dinner. Guest of Honour was Y.Bhg. Datuk J.Jayasiri, SecretaryGeneral of the Ministry of Interna onal Trade and Industry (MITI). The evening started off with networking cocktails at the courtyard. Mr Christophe Marque (AMMI Secretary) welcomed new members - Boston Scien fic, Cochlear Malaysia, Engineered Medical Systems and Owen Mumford with short and fun interview sessions. During dinner, guests were entertained by lovely Arabesque dancers. A special note of thanks to Bemis Asia Pacific Sdn. Bhd. and Synergy Sterilisa on (M) Sdn. Bhd. (now part of STERIS) as event sponsors.
16 AMMI Annual Report 2016
COMMITTEE LEADER: Ÿ
Mr Hitendra Joshi (B. Braun Medical Industries Sdn. Bhd.)
MEMBERS: Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ
Mr Lim Bee Leong (Bemis Asia Pacific Sdn. Bhd.) Mr John Ward (SteriPack Asia Sdn. Bhd.) Mr Yap Kee Keong (Texchem Life Sciences Sdn. Bhd.) Mr Chin Hock Meng (St. Jude Medical Opera ons (M) Sdn. Bhd.) Dato' Dr Haminnuddin Hj. Abdul Hamid (Ideal Healthcare Sdn. Bhd.) Mr Jason Ng (UWC Healthcare Manufacturing Sdn. Bhd.) Mr Andy Lee (Johnson & Johnson Sdn. Bhd.) Mr Mark Rauenzahn (Lake Region Medical Sdn. Bhd.) Mr Steve Morgan (Nitritex (M) Sdn. Bhd.)
AMMI’S ROLE IN POLICY ADVOCACY Chairman, Sub-Industry Working Group (Medical Devices), Industry Skills Commi ee, Na onal Human Capital Development Council Ÿ
Member, Medical Devices Investment Advisory Panel, Malaysian Investment Development Authority (MIDA) Ÿ
Member, Industry Standards Commi ee on Medical Devices and Facili es for Healthcare, Malaysian Na onal Standards Commi ee, Malaysian Standards and Accredita on Council Ÿ
Board of Trustees, Malaysian Rubber Export Promo on Council (MREPC)
Ÿ
Member, Sectoral Training Commi ee, Human Resources Development Council (HRDF)
Ÿ
Member, High Impact Programme (HIP) 5: Medical Devices Ini a ve Steering Commi ee, SME Corp. Malaysia Ÿ
Associate Member, Asia Pacific Medical Technology Associa on (APACMed)
Ÿ
AMMI Annual Report 2016
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MEETINGS & EVENTS 2016
24 February
Mr Hitendra Joshi, AMMI Chairman and several AMMI members met up with senior officers from MIDA. The objec ve of this mee ng was to follow up with interested members on the Principal Hub Incen ve Scheme which MIDA presented during the AMMI Q2 Progress Mee ng in 2015.
Mee ng with MIDA Regional Establishment & Supply Chain Division, Penang
Mr John Ward, AMMI Vice-Chairman, a ended the mee ng. Mr Ward suggested to explore poten al collabora on with MIDA on the training of fresh graduates and quality assurance (QA) specialists or a achment of fresh graduates with the industry. AMMI also agreed to take up the Chair for the Sub-Industry Working Group (Medical Devices) under the Industry Skills Commi ee.
4 April
9 March MIDA’s Medical Device Investment Advisory Panel (MDIAP) Mee ng, Kuala Lumpur
Mr John Ward a ended the mee ng and submi ed AMMI’s Collec ve Feedback for the 2017 Budget Incen ves Proposal. Refer to page 21 for full details.
MIDA Mee ng with Industry Associa ons, Kuala Lumpur
22 July Exclusive Dialogue Session with MIDA Top Management and Launch of the AMMI Medical Device Industry Outlook Report, Kuala Lumpur – Refer to page 20 for full details.
2 Aug & 20 Oct
Mee ng with SME Corpora on – Discussion on Pre-Implenta on of HIP5 Catalyst Programme – Medical Devices Ini a ves under SME Masterplan, Kuala Lumpur
AMMI became a member of the SME Corp HIP-5 Steering Commi ee. The objec ve of the commi ee is to help local home grown medical companies in various aspects, such as cer fica on and regula on support, marke ng strategy support, interna onal partner search, technology roadmap development and industry landscaping; and supply chain management.
Mr Jason Ng (UWC Healthcare Manufacturing Sdn. Bhd.) a ended the mee ng on behalf of AMMI. The objec ve of this mee ng is to discuss “how to boost our export as the increase in import is faster than export”.
23 August Human Resource Development Fund (HRDF) Sectorial Training Commi ee (STC) Membership Engagement Session, Kuala Lumpur 18 AMMI Annual Report 2016
8 August MOF Focus Group Mee ng : Budget 2017 - Enhancing Export Growth, Putrajaya
Mr Ching Choon Siong (AMMI Secretariat) represented AMMI in the mee ng. The objec ve of the mee ng is to encourage industry associa ons to join HRDF Sectoral Training Commi ee (STC) so that industry training programmes can be funded via HRDF Pool Fund by submi ng proposals for STC's approval. Update 31 August : AMMI joined the STC and will con nue to explore ways to help members to maximise their benefits from the HRDF Pool Fund.
MEETINGS & EVENTS 2016
6-7 September AMMI Par cipa on in the 8th IRGCE MARGMA Exhibi on, Kuala Lumpur
AMMI par cipated in the 2-day exhibi on at KL Conven on Centre. Aside from introducing AMMI to poten al members, AMMI representa ve, Mr Ching Choon Siong also spoke to visi ng groups of undergraduates about “Opportuni es in the Medical Device Industry”.
AMMI was the suppor ng associa on for the event. Mr Allen Ng, General Manager from Haemone cs (M) Sdn. Bhd. represented AMMI by giving a talk on “Opportuni es in the Medical Device Industry“ during the seminar.
8-10 November 2016 Asia Pacific Medtech Forum
Status update 20 December: Dispo-Med Sdn. Bhd., Diptech Industries Sdn. Bhd., GMMI Sdn. Bhd. and Symmetry Medical Sdn. Bhd. were selected by SMRJ to par cipate in the project.
8 December Visit by delegates from Taiwan - Industrial Development Bureau, Ministry of Economic Affairs, Biotechnology & Pharmaceu cal Industries Promo on Office (MOEA) and Metal Industries Research & Development Centre (MIRDC)
10 November Visit by Organiza on for Small & Medium Enterprises and Regional Innova on, Japan (SMRJ)
Mr Hitendra Joshi met up with the Taiwanese delegates in Kuala Lumpur. The purpose of their visit is to get to know more about the Medical Device Industry in Malaysia.
Mr Hitendra Joshi a ended the mee ng and highlighted the following issues : 1. Mapping of the medical device industry in Malaysia- We need to know exactly the number of manufacturers in the country and also the products they manufacture. This applies also to providers of services to the industry. The informa on should be available with the Medical Device Authority (MDA) since all manufacturers have to be registered with MDA. 2. Suppor ng local industry to par cipate fairly in MOH business. Greater coopera on needed from MOH to support local industry especially the smaller companies and those with higher local content and higher value-add.
Medical Technology Associa on of India (MTaI) Board and Fraternity Mee ng, New Delhi, India
Invest Penang SME Seminar Readiness for Medical Device Supply Chain, Penang
Mr Hitendra Joshi, Mr Christophe Maeque and Mr Ching Choon Siong a ended the forum in Singapore.
Dato’ Dr Haminnuddin hosted the SMRJ team from Japan at Concorde Hotel, Shah Alam. The objec ve of the mee ng was to introduce the SMRJ CEO Networking Project in Tokyo February 2017-annual programme business networking within the Japanese and the four ASEAN countries Malaysia, Indonesia, Thailand and Vietnam. Four slots are allocated to AMMI members to join this project in Japan. Seven AMMI companies applied to join the project.
19 December
20 October
14 December MIDA Medical Device Investment Advisory Panel (MDIAP) Mee ng, Kuala Lumpur
Mr Hitendra Joshi a ended the mee ng, which saw discussions by captains of the industry on Medical Device Rules, GST, Customs Du es, Orthopaedic and Opthalmic Projects and more.
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MEETINGS & EVENTS 2016
22 July AMMI-MIDA Dialogue Session and Launch of the AMMI Medical Device Industry Outlook Report
MIDA top management team and twenty- five AMMI members a ended the dialogue session which was chaired by MIDA CEO, Y.Bhg. Dato’ Azman Mahmud. This was followed by the launch of the AMMI Medical Device Industry Outlook Report 2016, officiated by Y.Bhg. Datuk N. Rajendran, MIDA Deputy CEO II. AMMI Chairman, Mr Hitendra Joshi gave a presenta on of the report, highligh ng the increase of members’ collec ve exports last year by 20% to reach RM8.3 billion. He reiterated that this represented more than 50% of Malaysia’s total exports of medical devices of RM15.5 billion in 2015. He then presented the AMMI Medical Device Industry Report 2016 to Y.Bhg. Datuk N. Rajendran. The launch was followed by a press conference and luncheon for invited guests.
ISSUES HIGHLIGHTED BY AMMI DURING DIALOGUE SESSION 1.
AMMI proposed a review of R&D incen ves to make it a rac ve for companies to bring more R & D ac vi es to the country.
2.
AMMI proposed to increase the ceiling of Automa on Capital Allowance for expenditure to RM 10 million.
3.
AMMI proposed that the off-take agreement (where Ministry of Health agrees to buy medical devices that are manufactured in the country for the first me) must give due regard to investments made by both local companies as well as mul -na onal companies in the country over imported products or local products with cursory local content.
4.
AMMI proposed that the MIDA Training Grant (currently applicable for ini al investment projects by a new company and limited up to first five years of opera ons) should be extended for new products or new technology transfers instead as this will help medical companies to con nue to expand and transfer new technologies and products to Malaysia.
20 AMMI Annual Report 2016
AMMI’S COLLECTIVE FEEDBACK Subject : 2017 Budget Incen ve Proposal for MITI and MIDA Submi ed : 4 April 2016
ISSUES AND PROPOSALS ISSUE 1: Incen ves for in-house R & D ac vi es in Malaysia are based on an outdated paradigm. The incen ves are limited to qualifying capital expenditure with no regard to intellectual assets. The incen ves remain una rac ve to companies that are engaged both in R & D and manufacturing in Malaysia. PROPOSAL : To review R & D incen ves to make it a rac ve for companies to bring more R & D ac vi es to the country. The incen ves should be extended to approved R & D centres and must include manpower and IP (Intellectual Property) costs. Cost of joint research with universi es and research centres should further be encouraged through the provision of grants.
ISSUE 2: Automa on Capital Allowance - current threshold is too low for medical device companies and glove manufacturers. NOTE Category 1: For high labour intensive industries (rubber products, plas cs, wood, furniture and tex les), an automa on capital allowance of 200% will be provided on the first RM4 million expenditure incurred within 3 years of assessment from 2015 to 2017; and Category 2: For other industries, automa on capital allowance of 200% will be provided on the first RM2 m i l l i o n ex p e n d i t u r e i n c u r r e d w i t h i n 5 y e a r s o f a s s e s s m e n t f r o m 2 0 1 5 t o 2 0 2 0 . PROPOSAL: To increase the ceiling of capital allowance expenditure to RM 10 million
ISSUE 3: There are currently too many restric ons and condi ons a ached to the off-take agreement where the government (Ministry of Health) agrees to buy medical devices that are manufactured in the country for the first me – making the incen ve una rac ve. PROPOSAL: The policy must give due regard to investments made by both local companies as well as mul -na onal companies in the country over imported products or local products with cursory local content.
ISSUE 4: Limita on on MIDA’s Training Grant – the grant is currently based on the ini al investment project by a new company and limited up to first five (5) years of opera ons. PROPOSAL : The training grant should be extended for new products or new technology transfers instead of being constrained by total company basis. This will help medical companies to con nue to expand and transfer new technologies and products to Malaysia.
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AMMI’S COLLECTIVE FEEDBACK Subject : Bank Negara Malaysia Foreign Exchange Rulings Compiled 26 December 2016 Issue No.1
Reten on of 25% export proceeds in Foreign Currency Account
AMMI Collec ve Feedback
The new measures have made Malaysia a harder place to operate export-oriented manufacturing business and more costly with exposure to forex risk, hedging services and double foreign exchange costs. The medical device industry is part of the global supply chain, hence natural hedge is the most effec ve way.
AMMI Request
We strongly request BNM considera on to exempt all AMMI member companies from this new BNM ruling. Ÿ Alterna vely, we would like to request reten on of up to 50% export proceeds in FCA. Ÿ We also would like BNM to provide re-assurance that re-conversion can be done at the same spot rate.
Issue No. 2
Payment in Malaysian Ringgit between residents
AMMI Collec ve Feedback
Currently there are local resident suppliers that our member companies deal with in USD as their major material components are affected by movements of USD. All these are supported with signed supply agreements which are not possible to change immediately. Due to the vola lity of MYR versus USD, it is always at our member companies’ disadvantage where suppliers are highly likely to factor that into the pricing in MYR, resul ng in addi onal costs for our member companies.
AMMI Request
We strongly request BNM considera on to allow all sales and payments between companies opera ng in FTZ, FIZ, LMW and Bonded warehouses to be in foreign currency to facilitate and support export for Malaysia.
Issue No. 3
Ÿ
Hedging not exceeding 6 months; Hedging without documentary evidence limited to RM6 million per client, per bank
AMMI Collec ve Feedback
Based on the analysis of our survey, majority of our member companies’ annual export sales and annual payables are in foreign currency with amount exceeding RM6 million. For longer term contracts, a longer hedging should be possible in general (not as an excep on) without addi onal approval as there is risk of delay of projects if approval is required to procced.
AMMI Request
We strongly request BNM considera on to allow a longer me-frame for hedging especially for longer term contracts without any approval. We also request that hedging limit for companies opera ng in FTZ, FIZ and LMW to be equal to value of annual sales without the need for further documenta on. Dynamic hedging should be equal to annual sales.
Issue No. 4
Approval for foreign current assets (FCA) with value more than RM50 million
AMMI Collec ve Feedback
For foreign currency that is available on our member companies’ FCA, addi onal approval should not be required. This would slow down business transac ons and would require a lot of documenta on and administra ve efforts. If foreign currency is available in FCA, any limita on of business transac ons is not acceptable.
AMMI Request
We strongly request BNM considera on to waive BNM approval requirement on this issue.
22 AMMI Annual Report 2016
COMMITTEE LEADER: Ÿ Ÿ
Ong Yean Ting (Johnson & Johnson Sdn. Bhd.) – un l September 2016 Dato' Dr Haminnuddin Hj. Abdul Hamid (Ideal Healthcare Sdn. Bhd.) – from October 2016
MEMBERS: Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ
Mr Christophe Marque (Stereo Sdn. Bhd.) Ms Gan Poh Siew (Haemone cs Malaysia Sdn. Bhd.) Ms Chuah Chiew Teng (3M Malaysia Sdn. Bhd.) Ms Chuah Siew See (Teleflex Medical Sdn. Bhd.) Ms Quek Lang Fah (B.Braun Medical Industries Sdn. Bhd.) Mr Jason Ng (UWC Healthcare Manufacturing Sdn. Bhd.) Mr Muhammad Juzaili Jamil (Ideal Healthcare Sdn. Bhd.) Mr Alfred Ho (Texchem Life Sciences Sdn. Bhd.) Ms Queenie Lee Ching Hoay (KLS Mar n Sdn. Bhd.) Ms Grace Wong (Johnson & Johnson Sdn. Bhd.) Ms Chloe Tan (Medtronic-Mediquip Sdn. Bhd.)
MEETINGS AND FEEDBACK 25 May: Industry Standards Commi ee – Medical Device (ISC R) mee ng, SIRIM, Shah Alam Ms Chuah Chiew Teng (3M Malaysia Sdn. Bhd.) represented AMMI in the mee ng. Key takeaways from the mee ng: 1. Updates on Good Lab Prac ce (GLP) facili es in Malaysia • Biocompa bility Lab or “Makmal Bioserasi” in UKM (for biocompa bility studies only) - will be ready soon. • MyBioScienceLab (MBSL) in Malacca (for full range of ISO10993 tests) - 90% of its infrastructure is completed. • Ins tute for Medical Research (IMR) lab is cer fied and available for toxicology tests. 2. ISC R is officially adop ng the ISO13485: 2016. Companies cer fied to the earlier version. (MS ISO13485: 2006) has 3 years for transi on to the latest version, which ends March 2019.
30 May : AMMI Feedback to Medical Device Authority (MDA) on Medical Device Labelling Implementa on AMMI collec vely proposed a 3-year transi onal period. Among jus fica ons given were me and capital investments required for purchase of new label prin ng equipment. Refer to full details on page 25.
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MEETINGS AND FEEDBACK 13 September & 19 October : MDA Mee ng with Industry – Dra Guidance on Code of Adver sement for Medical Device, Putrajaya The first mee ng was a ended by Ms Chuah Chiew Teng (3M), Ms Chloe Tan (Medtronic) and Ms Grace Wong (Johnson & Johnson). The subsequent mee ng was a ended by Ms Chloe Tan. The following issues are pending commi ee decision Ÿ 3.3.2 Endorsement by Health Professionals - Sugges on to exclude this clause for adver sement to Healthcare Professionals (HCP) Ÿ 3.3.7 Superla ves – Sugges on to exclude this clause for HCP Ÿ 3.4.1 Claims rela ng to ageing and premature ageing and Annex B – Sugges on to exclude word an -ageing Ÿ 3.10.2, 3.10.3 and 3.10.5 – Sugges on to exclude these clauses for adver sement to HCP.
30 September: AMMI Nomina ons for the MDA Medical Research and Ethics Commi ee 2016-2018 AMMI nominated Dato’ Dr’ Haminnuddin (Ideal Healthcare Sdn. Bhd.) as Representa ve and Mr Jason Ng (UWC Healthcare Manufacturing Sdn. Bhd.) as Alternate Representa ve.
13 October : MDA Mee ng with Industry : Dra Guidance: “Guideline For Registra on Of Drug-Medical Device And Medical Device-Drug Combina on Products”, Putrajaya Dato’ Dr Haminnuddin and Ms Grace Wong (Johnson & Johnson Sdn.Bhd.) represented AMMI in the mee ng. Issues highlighted by the industry were transi on period / effec ve date, parallel submission to NPRA and MDA, GDPMD/ GMP/ISO requirement, validity period for endorsement le er, process meline review in the event the drug and device obtained approval separately, endorsement le er by NPRA/MDA and change/ varia on issues. All are s ll pending final decision from MDA. 26 October : MDA Seminar with Medical Device Industry, Penang Ms Gan Poh Siew (Haemone cs Malaysia Sdn. Bhd. ) and Ms Queenie Lee (KLS Mar n Sdn. Bhd.) a ended the seminar on behalf of AMMI. Topics presented during the seminar were : Ÿ New Policies and Guidelines to Support the Implementa on of Medical Device Act Ÿ Registra on by way of Verifica on Process Ÿ Medical Device Exemp on Order 2016 Ÿ Establishment Licensing Ÿ Cer ficate of Free Sale, Export Permit, Off-take Agreement and Future Programmes for Industrial Support Ÿ New Requirements for Regula ng Labelling Ÿ Post Market Surveillance & Vigilance
1 December : Industry Standards Commi ee – Medical Device (ISC R) Mee ng, SIRIM, Shah Alam Ms Chuah Chiew Teng (3M Malaysia Sdn.Bhd.) represented AMMI in the mee ng. She reported that the 2nd Medical Device Regula on will consist of (1) Adver sement (2) Maintenance (3) Post Market Surveillance and (4) Designated Medical Device (eg: devices used in beauty salon – laser etc.) users will also be regulated.
24 AMMI Annual Report 2016
AMMI’S COLLECTIVE FEEDBACK Subject : Transi onal Period for Implementa on of Medical Device Labelling Submi ed : 30 May 2016 PROPOSED TRANSITIONAL PERIOD : 3 years AMMI proposes a stepwise approach in enforcing the labelling requirement over a period of three (3) years – which will be more feasible when the industry has se led down with the current registra on exercise.
JUSTIFICATION ON PROPOSED TRANSITIONAL PERIOD 1. EQUIPMENT Purchase of new label prin ng equipment requires me and capital investments (sourcing, equipment qualifica ons, so ware valida on, training). Ÿ Re-configura on of exis ng prin ng equipment to cater for the new labelling requirements (equipment qualifica ons, so ware valida on, training). Ÿ
2. LABELLING Label design, review and approval of artworks and language transla on (Internal and External Par es) requires me and resources. Ÿ Purchase of new labels requires me and resources (artwork design/redesign, verifica on, order lead me, inspec on etc.). Ÿ Industry will require MDA to allow “s ckering” of labels. Ÿ
3. PHASING OUT OF CURRENT STOCKS Clearance of exis ng label stocks – me required especially for slow moving products Clearance of physical stocks with exis ng labels from manufacturing plants, warehouses, distribu on centers and distributors. Ÿ Phased transi on from exis ng to new labels for marketed products. Ÿ Cost factor - Inventory/stock of old artwork to be used before replenishing the new. Also, some devices are slow-moving. Ÿ Ÿ
4. UPDATE OF PRODUCT REGISTRATION The “Registered with MDA” label can only be affixed a er obtaining registra on approval from MDA. Registra on is by “family”, hence revision of numerous artwork will be required at any one me. Addi onal transi on period is required upon approval, in order to revise the artwork and labels of products. Ÿ The industry needs MDA’s confirma on that the labelling of “Registered with MDA” is mandatory for devices placed in the Malaysian market only (and not required for export). Ÿ A transi on period is required before the company obtains the cer ficate from MDA. This is important for those products which its registra on applica on has been submi ed to MDA before 30th June 2016 and have the benefit of con nuous commercial ac vity in local market. Ÿ Time and resources needed at MDA to review and approve new labels in the product registra on dossier. In addi on, for the export market (for products with shared labels with other countries), ample transi on me is required to revise artwork and receive approval from other markets before new labels can be implemented. Ÿ
AMMI Annual Report 2016
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COMMITTEE LEADER: Ÿ Mr Yap Kee Keong, Texchem Life Sciences Sdn. Bhd. MEMBERS: Ÿ Mr Hitendra Joshi, B. Braun Medical Industries Sdn. Bhd. Ÿ Mr Suwit Tunlayadechanont, Synergy Sterilisa on (M) Sdn. Bhd. (now part of STERIS) Ÿ Mr Chin Hock Meng, St. Jude Medical Opera ons (M) Sdn. Bhd. Ÿ Dato' Dr Haminnuddin Hj. Abdul Hamid, Ideal Healthcare Sdn. Bhd. Ÿ Mr Michel Van Crombrugge, Paramit Malaysia Sdn. Bhd. Ÿ Ms Jess Tew, KLS Mar n Malaysia Sdn. Bhd. ACTIVITIES AND EVENTS 25 March
Career Talk at University of Science Malaysia (USM) Penang Mr Hitendra Joshi gave a presenta on on the “Opportuni es in the Medical Device Industry” to over 100 USM students.
12 April
AMMI Medtech Talent and Employment Programme (MTEP) Batch 2 Comple on Ceremony, Sunway Hotel, Penang
21 - 22 April
Training: ISO13485: 2016 Internal Audi ng, Majes c Hotel, Kuala Lumpur
6 May
AMMI HR Forum and Networking Mee ng, E&O Hotel, Penang
1 - 2 June
Training: Medical Device Manufacturing Process Valida on, E&O Hotel, Penang
5 - 6 October
Training: Transi on to ISO13485: 2016 Quality Management System, E&O Hotel, Penang Training: Risk Management for Medical Devices, G Hotel Gurney, Penang
18 October
AMMI HR Forum and Networking Mee ng, Hilton Hotel, Petaling Jaya
9 - 10 November
Training: FMEA for Medical Device Manufacturing, E&O Hotel, Penang
29 November
Training: Fundamentals of Steriliza on, Concept to Market, Rou ne Valida on and Control, Eas n Hotel, Penang
20 -21 July
26 AMMI Annual Report 2016
12 April : AMMI-NCIA Medtech Talent and Employment Programme Comple on Ceremony at Sunway Hotel, Penang T h e A M M I - N C I A M e d t e c h Ta l e n t a n d Employment Programme Batch 2 concluded with the Comple on Ceremony for the graduate trainees. Mr Michael Raja, Manager of Educa on & Human Capital Development, of Northern Corridor Implementa on Authority (NCIA), together with Mr Hitendra Joshi (AMMI Chairman) and Mr Yap Kee Keong (AMMI Director & Leader of Talent Development Commi ee) presented the cer ďŹ cates to the graduate trainees. Also in a endance were Cik Azhana Bin Mohamed Saleh (Director, MIDA Penang), Encik Abdul Muk bin Abu Bakar (Director, MIDA Kedah & Perlis), Puan Nor Asmahan Othman (Industry Partnership, Talent Corp) and representa ves from par cipa ng companies.
Abio Orthopaedics Sdn. Bhd.
B.Braun Industries Sdn. Bhd.
Synergy Health Sterilisa on Sdn. Bhd. (now part of STERIS)
Epsilon Medical Device Sdn. Bhd.
Haemona cs Malaysia Sdn. Bhd.
UWC Healthcare Mfg Sdn. Bhd.
Penchem Medical Sdn. Bhd.
Teleex Medical Sdn. Bhd.
AMMI Annual Report 2016
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6 May, E&O Hotel, Penang
6 May & 18 October AMMI HR Forums and Networking Mee ngs The main objec ve of the forums is to provide a networking pla orm for human resource professionals of member companies to discuss and exchange ideas on current human resource and talent issues. Topics presented during these forums were on Compensa on and Benefits (by speakers from Korn Ferry Hay Group) and the Impact of TPPA on the Labour Law (by representa ve from Ministry of Human Resources). Members also par cipated in sharing sessions on employee mo va on and reten on.
18 October, Hotel Hilton Petaling Jaya
AMMI also introduced the interac ve “World Café Workshop” during the AMMI HR Forum held in Petaling Jaya on 18 October. Led by Ms Cynthia Ooi (Vice-President of Human Resources, B.Braun Medical Industries), Mr Joshua Chong (Senior Human Resource Manager, Ambu) and Encik Ahmad Nordin (Assistant General Manager, Texchem Group), par cipants were divided into three groups and worked on topics : (1) Sharing Employee Reten on Strategies (2) Engaging Your Employees (3) Employee Mo va on The workshop encouraged a lot of sharing among par cipants and was very highly rated.
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AMMI organised six public training classes and trained over 180 par cipants in 2016
21-22 April: ISO13485: 2016 Internal Audi ng, Majes c Hotel, Kuala Lumpur No. of Par cipants: 27 No. of Companies: 14
1-2 June: Medical Device Manufacturing Process Valida on, E&O Hotel, Penang No. of Par cipants: 18 No of Companies: 10
5-6 October: Risk Management for Medical Devices, G Hotel Gurney, Penang No. of Par cipants: 27 No. of Companies: 12
20-21 July: Transi on to ISO13485: 2016 Quality Management System, E&O Hotel, Penang No of par cipants: 40 No of companies: 18
9 - 10 November: FMEA in Medical Device Manufacturing, E&O Hotel, Penang No. of Par cipants: 15 No. of Companies: 6
29 November: Fundamentals of Steriliza on, Concept to Market, Rou ne Valida on and Control, Eas n Hotel, Penang No. of Par cipants: 46 No. of Companies: 21 AMMI Annual Report 2016
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1. Medical Device Exports Set to Rise, New Straits Times - 23 July 2016 2. Eksport Peralatan Perubatan Dijangka Cecah RM17 bilion, Berita Harian Online - 22 Julai 2016 (h p://www.bharian.com.my/node/175872) 3. Export of Medical Devices Increase by 15% and is Expected to Hit RM17.8 billion, Nanyang Siang Pau - 23 July 2016 4. Medical Device Exports to Increase to RM17.8 billion, The Borneo Post - 23 July 2016 (h p://www.theborneopost.com/2016/07/23/medical-device-exports-to-increaseto-rm17-8-billion/) 5. Export of Medical Tools to Hit RM18b,The Malaysian Reserve -25 July 2016 6. Malaysia’s Manufacturing Medical Devices Export to Reach RM17 billion in 2016 SME Magazine, Asia - 26 July 2016 (h p://smemagazine.asia/2016/07/ malaysias-manufacturing-medical-devices-export-to-reach-rm17-billion-in-2016/) 7. Malaysia Recorded Outstanding Value Added Ra o in Manufacturing Medical Devices, Export Growth to Reach RM17 Billion in 2016, Bernama News - 22 July 2016 (h p://www.bernama.com/bernama/v8/newsindex.php?id=1265462)
30 AMMI Annual Report 2016