AMMI Annual Report 2017 by AMMI

ANNUAL REPORT

2017

TABLE OF CONTENTS

2-3

4-5

CHAIRMAN’S MESSAGE

ABOUT AMMI

BOARD OF DIRECTORS & SECRETARIAT TEAM

AMMI COMMITTEES

8-11

12-17 18-20 21-27

GOVERNMENT AFFAIRS & POLICY

TALENT DEVELOPMENT

28-33 34 AMMI MEMBERS’ DIRECTORY

AMMI IN THE NEWS

REGULATORY & TECHNICAL

MEMBERSHIP

CHAIRMAN’S MESSAGE On behalf of the Board of Directors, I am pleased to present to our members, the Association of Malaysian Medical Industries (AMMI) Annual Report for the year ending 31 December 2017. Malaysia continues to evolve as a hub for medical device manufacturing in line with the vision of AMMI’s Strategic Roadmap 2020 to establish Malaysia as the preferred global manufacturing location for medical technology. In AMMI’s annual survey, AMMI members’ cumulative investments amounted to RM6.0 billion in 2016, as compared to RM5.1 billion in 2015. The increase reflects investors’ confidence in the Medical Device Industry in Malaysia. AMMI’s survey also recorded: • Members’ collective exports in 2016 increased by 17% to reach RM9.76 billion, accounting for more than 60% of Malaysia’s total exports of medical devices of RM15.8 billion in 2016; • An outstanding average value-added ratio of 57% in manufacturing medical devices in Malaysia. RM2.8 billion or 63% worth of raw materials and services locally sourced from within Malaysia; • AMMI members spent a total of RM49.0 million in research & development (R&D) activities in 2016, propelling a gradual shift towards higher-value added and innovative medical devices.

HIGHLIGHTS OF 2017 The Board is pleased to report that our Association is in good financial position, with all our events and training being self-sustainable. There is a key change to the voting system in the AMMI constitution, after its Extraordinary General Meeting in June - whereby the person who is voted into the Board will then be elected into the position by the Board. AMMI is pleased to welcome six new members in 2017, bringing the total to sixty-four members. They are Biocon Sdn Bhd, Medtronic Malaysia Sdn Bhd, Multivac Sdn Bhd, PMA Manufacturing Sdn Bhd, Ried Q&C Consultancy Sdn Bhd and Tomoe Malaysia Sdn Bhd. Engagements with government ministries and agencies continue to be a priority for AMMI. The AMMI Medical Device Industry Report 2017 was jointly launched with the Malaysia Investment Development Authority (MIDA) in August 2017 for the third consecutive year. The report continues to provide invaluable insight into the medical device industry in Malaysia. AMMI also held an exclusive dialogue session with MIDA to discuss challenges faced by industry players. In collaboration with MIDA, AMMI organised an Engagement and Networking Session with Captains of Medical Device Industry in Johor. 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 has been appointed by MIDA to join both the Steering Committee and Technical Committee of the Environmental Scan for the Human Capital Issues within the Medical Devices Sector. The study focuses on the baseline study of the medical device industry landscape, manufacturing ecosystem and regional clusters in Malaysia. In addition, the study also focuses on determining the profile of the current and future work force and job mapping within the Medical Device Industry. AMMI’s Regulatory and Technical Committee certainly had a very challenging year, with many key issues related to new standards and regulations. A major achievement for AMMI (together with relevant industry associations) was to successfully convince the Board of Medical Device Authority to grant an extension of six months until 30 June 2018 for full enforcement on the registration requirement for medical devices under Section 5 of the Medical Device Act 2012. A word of thanks to all the co-opted members of the Regulatory and Technical Committee, governmental agencies and authorities in championing these key issues. 2

AMMI ANNUAL REPORT 2017

CHAIRMAN’S MESSAGE AMMI achieved another milestone in its Talent Development pillar, by successfully obtaining funding from the Human Resources Development Fund (HRDF) to implement the AMMI Medtech Certification Programme with the aim to accelerate skills of employees in the member companies in 4 different technical courses. The courses are Medtech Manufacturing Excellence Course, Medtech Quality Professional Course, Medtech Technical Competency Course and Medtech Regulatory Compliance Course. The AMMI Medtech Certification Programme’s course content and its curriculum are based on the validated competencies of an industry expert group under AMMI Regulatory & Technical Committee. The programme will benefit 100 employees from member companies. In 2017, AMMI organised several exclusive events, bringing in global experts to speak on topics such as the EUMDR, FDA Design Control and Conducting FDA Style Mock Audit, Global Unique Device Identification Database (GUDID) for all Medical Devices, Digital Health and Cybersecurity Issues, Medical Device Packaging and Sterilization. These global expert sharing sessions will continue to be an important part of AMMI’s Talent Development objectives. AMMI successfully organised 9 public training courses and trained 324 participants in 2017. AMMI also organised a HR Leaders’ Roundtable with the objective of creating a stronger voice in championing common issues and charting strategic agenda. AMMI invited Dr Juergen Schloesser, Senior Vice President, B. Braun Medical Industries to speak at its first CEO Evening Talk on Industry 4.0 for the Medical Device Industry. AMMI also set up an Industry 4.0 Taskforce to actively work on more workshops and sharing on the topic of Industry 4.0 for the Medical Device Industry.

LOOKING AHEAD Competition from manufacturers in China, India and Vietnam will continue 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 2018. On behalf of the Board of Directors, I would like thank all those who have supported our Association. The Association’s role and its contribution to the development of the medical devices industry is increasingly being recognised by government ministries and agencies such as Ministry of International Trade and Industry (MITI), Ministry of Health (MOH), Ministry of Science, Technology & Innovation (MOSTI), Economic Planning Unit (EPU), Medical Device Authority (MDA), Malaysian Investment Development Authority (MIDA), Malaysia External Trade Development Corporation (MATRADE), SME Corporation, HRDF, Malaysian Rubber Export Promotion Council (MREPC) and Department of Standards. 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 appreciation to our members for their active participation at our meetings and events. I am thankful to the Board of Directors for their valuable contribution, advice and active engagement without which our Association would not have progressed this far. Finally, my grateful thanks to the seconded staff of Medsociate Sdn Bhd, our Secretariat for rendering services professionally to the Association and to its members.

HITENDRA JOSHI Chairman December 31, 2017

AMMI ANNUAL REPORT 2017

ABOUT AMMI

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VISION “Establish Malaysia as the preferred global manufacturing location for medical technology.”

MISSION “Promote and strengthen best in class manufacturing operations in Malaysia by identifying and promoting appropriate processes, structures, policies and support required to facilitate manufacturing and operational excellence.”

} }

Formed in 1989, the Association of Malaysian Medical Industries (AMMI), represents leading medical device manufacturing companies in the medical technology industry in Malaysia. AMMI currently has 64 member companies and collectively, they account for more than half of the total export revenue for “Made-in-Malaysia” 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 continue 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 production facilities.

QUICK STATS JOBS

Members collectively accounted for

60%

Export of Medical Devices

RM9.76

Employed more than

of collective export value in 2016

knowledge-based workforce

billion

31,000

AMMI ANNUAL REPORT 2017

ABOUT AMMI AMMI 2020 STRATEGIC ROADMAP PILLAR 1:

PILLAR 2:

POLICY ADVOCACY

TALENT DEVELOPMENT

STRATEGIC PILLARS

PILLAR 4: MEDICAL TECHNOLOGY INDUSTRY DEVELOPMENT

PILLAR 3: INNOVATION AND R&D

PILLAR 1: POLICY ADVOCACY

PILLAR 3: INNOVATION AND R&D

OBJECTIVE

A recognised voice in the Medical Technology industry by driving balanced policy advocacy.

Create and support an environment for Medical Technology innovation through government, academia and industry partnerships.

PILLAR 2: TALENT DEVELOPMENT

PILLAR 4: MEDICAL TECHNOLOGY INDUSTRY DEVELOPMENT

OBJECTIVE

1. Support continuous development of a skilled and adaptable workforce. 2. Increase awareness of opportunities in the medical technology sector. 3. Facilities transfer and sharing of knowledge within our industry.

Facilitate new start-ups, growth and expansion for SMEs and MNC.

AMMI ANNUAL REPORT 2017

AMMI BOARD OF DIRECTORS

CHAIRMAN

VICE CHAIRMAN

Mr Hitendra Joshi

Mr John Ward

Mr Christophe Marque

SECRETARY GENERAL

TREASURER

Mr Eow Hu Teik

Mr Yap Kee Keong

2016-2018

2017-2019

DIRECTOR

2017-2019

DIRECTOR

2017-2019

2016-2018

2017-2019

2017-2018

Mr Suwit Tunlayadechanont

Datoâ&#x20AC;&#x2122; Dr Haminnuddin Hj. Abdul Hamid

Mr Michel Van Crombrugge

Mr Tom Mangan

RETIREMENTS & RESIGNATIONS

Vice Chairman, Mr Lim Bee Leong (Bemis Asia Pacific) retired in May 2017 Treasurer, Mr Chin Hock Meng (Abbott) retired in May 2017 Director, Mr Michael Goh (Johnson and Johnson) served between May - August 2017

SECRETARIAT TEAM

EXECUTIVE DIRECTOR Mr Ching Choon Siong 6

HEAD OF MARKETING & COMMUNICATIONS Ms Melissa Khoo

HEAD OF ADMIN Ms Heng Ee Ling

AMMI ANNUAL REPORT 2017

AMMI COMMITTEES GOVERNMENT AFFAIRS AND POLICY COMMITTEE Leader: Mr Hitendra Joshi (B. Braun Medical Industries) Mr John Ward (SteriPack Contract Manufacturing) Mr Christophe Marque (Stereo) Mr Yap Kee Keong (Texchem) Dato’ Dr Haminnuddin Hj. Abdul Hamid (Ideal Healthcare)

TALENT DEVELOPMENT COMMITTEE Leader: Mr Yap Kee Keong (Texchem) Mr Eow Hu Teik (Abbott) Mr Suwit Tunlayadechanont (STERIS) Mr Michel Van Crombrugge (Paramit) Mr Tom Mangan (CR Bard) Co-opted Members Mr Joshua Chong (Ambu) Mr Mohamed Anwar (Paramit) Ms Cynthia Ooi (B. Braun) served until November 2017 Ms Chee Wei Bee (Abbott) served until June 2017

REGULATORY & TECHNICAL COMMITTEE Leader: Dato’ Dr Haminnuddin Hj. Abdul Hamid (Ideal Healthcare) Mr Eow Hu Teik (Abbott)

Co-opted Members Ms Gan Poh Siew (Haemonetics) Ms Kek Soo Ling (Abbott) Ms Koh Seok Ling (Ambu) Mr Khor Siek Meng (Ansell) Mr Gobu Devarajan (Ansell) Ms Seow Lan Hoon (Ansell) Ms Chuah Chiew Teng (3M) Mr Jason Ng (UWC Healthcare Manufacturing) Mr Juzaili Jamil (Ideal Healthcare) Mr Alfred Ho (Texchem) Ms Queenie Lee Ching Hoay (KLS Martin) Ms Grace Wong (Johnson & Johnson) Ms Chloe Tan (Medtronic) Ms Yew Saw Peng (B. Braun Medical Industries) Mr Azhan Mokhtar (Fresenius Medical Care) Ms Nur Aqilah (Terumo Malaysia)

MEMBERSHIP COMMITTEE Leader: Mr John Ward (SteriPack Contract Manufacturing) Mr Christophe Marque (Stereo) Mr Suwit Tunlayadechanont (STERIS) Mr Michel Van Crombrugge (Paramit)

AMMI ANNUAL REPORT 2017

GOVERNMENT AFFAIRS & POLICY

AMMI Dialogue Session with MIDA Top Management, 2 August 2017.

KEY HIGHLIGHTS

• Launch of AMMI Medical Device Industry Outlook Report in collaboration with MIDA • Exclusive AMMI Dialogue Session with MIDA Top Management

AMMI’S ROLE IN POLICY ADVOCACY Chairman, Sub-Industry Working Group (Medical Devices), Industry Skills Committee National Human Capital Development Council Member, Medical Devices Investment Advisory Panel, Malaysian Investment Development Authority (MIDA) Member, Industry Standards Committee on Medical Devices and Facilities for Healthcare, Malaysian National Standards Committee, Malaysian Standards and Accreditation Council

Board of Trustees, Malaysian Rubber Export Promotion Council (MREPC)

Member, Sectoral Training Committee, Human Resources Development Fund (HRDF)

Member, High Impact Programme (HIP) 5: Medical Devices Initiative Steering Committee, SME Corp. Malaysia

Associate Member, Asia Pacific Medical Technology Association (APACMed)

AMMI ANNUAL REPORT 2017

GOVERNMENT AFFAIRS & POLICY

AMMI-MIDA JOINT LAUNCH OF THE AMMI MEDICAL DEVICE INDUSTRY OUTLOOK REPORT 2017

AUGUST MIDA CEO, Y. Bhg. Dato’ Azman Mahmud officiated the launch which was held at MIDA Sentral, Kuala Lumpur. The event was attended by MIDA top management team, AMMI Board of Directors and Members, as well as invited guests and the media. In his welcome speech, Y. Bhg. Dato’ Azman Mahmud noted that the presence of many MNCs has contributed to the development of a comprehensive local supply chain benefitting many local players. In his presentation, AMMI Chairman, Mr Hitendra Joshi highlighted that AMMI recorded an out standing value-added ratio of 57% in manufacturing medical devices in Malaysia with some RM2.84 billion or 63% worth of raw materials and services

locally sourced from within the country. This reflects AMMI’s commitment in supporting government initiatives to develop local small and medium-sized enterprises (SMEs). In addition, over 70% of AMMI members surveyed are expected to invest a total of RM1.4 billion in the country in 2017 - a strong signal by way of investor confidence in the Malaysia. The launch was followed by a joint press conference, attended by Y. Bhg. Dato’ Azman Mahmud, Y. Bhg. Datuk N. Rajendran (MIDA Deputy CEO II), Mr Hitendra Joshi and Mr H.T Eow (AMMI Secretary of the Board); and over 20 media members. Guests then adjourned for networking lunch after the press conference.

DIALOGUE SESSION WITH MIDA

AUGUST AMMI members attended an exclusive dialogue session with MIDA top management at MIDA Sentral, Kuala Lumpur, to discuss important issues faced by the medical device industry. Hitendra Joshi presenting the AMMI Medical Device Industry < Mr Outlook Report to MITI Minister, YB Dato’ Sri Mustapa Mohamed

AMMI ANNUAL REPORT 2017

GOVERNMENT AFFAIRS & POLICY DATE

MEETING/EVENT

20-25 January ASEAN-Japan CEO Network Enhancing Project in Japan 25 February

SMECorp – HIP 5: Medical Devices Steering Committee Meeting

14 March

SMECorp – HIP 5: Medical Devices Initiative Launching The following AMMI member companies received the Letter of Award as Tier 1 companies, each receiving 50% Matching grant of up to RM200,000 per company.

14 April

MOH - Consultation Session to Discuss Request List Under the Malaysia-European Union Free Trade Agreement (MEUFTA)

21 April

SMECorp – HIP5: Medical Devices Steering Committee Meeting

5 May

Meeting with Mr Johan Merican, Deputy DG of EPU

12 July

US Ambassador Meets AMMI Members (US Companies) at Abbott, Penang

21 July

Meeting with MARGMA and MREPC Malaysian Medical Association (MMA) Dinner

28 July

Meeting with South Australian Minister for Health, The Hon. Jack Snelling at B. Braun, Penang

2 August

Launch of AMMI Medical Device Industry Outlook Report at MIDA and Dialogue Session with MIDA top management

3 August

National Transformation 2050 (TN50) Industry Workshop by EPU

4 August

ASEAN@50 Commemorative Dinner, Kuala Lumpur

28 August

MATRADE & PEMANDU Meeting on Export Incentives Proposal to MOF SMECorp HIP5 Medical Device Steering Committee Meeting

11 October

AMMI Meeting with Japan Association of Clinical Reagent Industry (JACRI) and Japan Analytical Instrument Manufacturer’s Association (JAIMA).

21 November AMMI Event in Collaboration with APACMed on “Implementation of Code of Ethics in Malaysia 12 December

MIDA’s Medical Device Investment Advisory Panel Meeting

AMMI ANNUAL REPORT 2017

GOVERNMENT AFFAIRS & POLICY

Left to right: Mr Campbell Clark, Y. Bhg. Dato’ Dr Jacob Thomas, Mr Chin Keat Chyuan and Dr Koh Kar Chai

NOVEMBER

AMMI EVENT ON “IMPLEMENTATION OF CODE OF ETHICS IN MALAYSIA”, IN COLLABORATION WITH APACMED

Seventy-six members and guests attended the event which was held at Pullman Bangsar, Kuala Lumpur. The objective of the event was to promote ethical interactions between the medical technology industry and health care professionals.

Keynote speaker, Mr Campbell Clark, Chief Ethics & Compliance Officer, Asia Pacific, Medtronic and Chair, Legal/Ethics & Compliance Committee, APACMed, gave a presentation on the Implementation of Code of Ethics in Asia Pacific. Mr Clark then led the panel discussion with three other distinguished panel members, Y. Bhg. Dato’ Dr Jacob Thomas, President, Association of Private Hospitals of Malaysia (APHM), Mr Chin Keat Chyuan, Managing Director, Johnson & Johnson (M) Sdn Bhd and Dr Koh Kar Chai, Honorary General Secretary of Malaysian Medical Association (MMA).

ASEAN-Japan CEO Network Enhancing Project, Japan Left to right: Oon Gaik Bee, NC Leow, CS Ching, Frank Kubik, Soh Swee Hua

US Ambassador meets AMMI Members at Abbott, Hitendra Joshi presenting the AMMI Industry Outlook Report to South Australian Minister for Penang Health, The Hon. Jack Snelling Left to right : Dave Mitchell, HT Eow, H.E. Kamala Shirin Lakhdhir, Hitendra Joshi, Soh Swee Hua, Shakilla Shahjihan, Khoo Soo Seet, Ramu Iyer, Siobhan Das (AMCHAM), CS Ching AMMI ANNUAL REPORT 2017

TALENT DEVELOPMENT KEY HIGHLIGHTS • Obtained HRDF funding for the AMMI Medtech Certification Programme to run four medtech courses to train 100 industry professionals in 2018. • Hosted 3 Global Expert Sharing Sessions attended by 125 pax. • Organised 9 Public Training and 2 In-house Training. Trained over 400 participants. • Hosted the AMMI HR Leaders’ Roundtable.

AMMI HR Leaders’ Roundtable, 11 May 2017

AMMI HR LEADERS’ ROUNDTABLE

MAY

Seventeen HR leaders of AMMI member companies came together for a round table discussion at Equatorial Hotel, Penang. The objective of the event was to create a stronger voice in championing common issues and chart strategic agenda. All agreed that it was crucial to create branding for the Medical Device Industry to attract talent through Medtech Industry Awareness Programmes and work together to solve talent retention issues.

AMMI ANNUAL REPORT 2017

TALENT DEVELOPMENT DATE

MEETING/EVENT

20 March

HRDF Pool Fund Strategic Initiative Launching

7 June

MIDA Talent Division Meeting

2 August

AMMI - MIDA Talent Division Meeting - Study on Environmental Scan for Human Capital Issues within the Medical Devices Sector.

22 November HRDF Back to Work Upskilling Briefing 28 November HRDF Conference

Medtech Certification Programme for Medical Device Industry

Target Group

Medtech Regulatory Compliance Course

Regulatory affairs professionals

Medtech Manufacturing Excellence Course

Manufacturing team/engineers

Medtech Technical Competency Course

Cross functional team members

Medtech Quality Professional Course

Quality professionals

AMMI ANNUAL REPORT 2017

TALENT DEVELOPMENT GLOBAL EXPERT SHARING

AMMI BREAKFAST TALK BY LINDA CHATWIN

MAY

The Breakfast Talk was by Ms Linda Chatwin, Esq, RAC, from UL. She spoke on the topic of GUDID Database of all Medical Devices, Digital Health and Cybersecurity issues. This exclusive AMMI senior management session was held at E&O Hotel, Penang and was attended by twenty participants from Abbott, B. Braun, Bemis, KLS Martin, Mediquip, Molnlycke, Sanmina SCI, Teleflex, Top Glove, UWC and invited guest from CREST.

NOVEMBER

AMMI TEA-TALK ON EU MEDICAL DEVICE REGULATIONS

Over sixty members and guests attended the event which was held at E&O Hotel, Penang. The event provided insight and facilitated discussion among AMMI members and key stakeholders on the impact of the new Medical Device Regulations in Europe for the Medical Device Industry. Key Speaker, Mr Juergen Heil, Senior Vice President Quality & Environment Management, B. Braun Melsungen AG, Germany gave a presentation on “Challenges and Expectations of the New Medical Device Regulations in Europe for the Medical Device Industry”. This was followed by a panel discussion led by Mr Frank Ried, Director of Ried Q&C Consultancy. Panel members included Mr Juergen Heil, Mr Peter Porzler, Vice President, Medical & Health Service (MHS), TUV SUD and Mr Tony Low, Director of Quality Assurance & Regulatory Compliance, Commissioning Agents International.

Left to right : Mr Juergen Heil, Mr Frank Ried, Mr Peter Porzler and Mr Tony Low

AMMI ANNUAL REPORT 2017

TALENT DEVELOPMENT AMMI PUBLIC TRAINING

ISO13485 : 2016 QMS 5-6 April 2017, Dorsett Grand Subang Trainer: Mr Tony Low Total no of participants: 18 Total no of organisations: 10

FDA Design Control & Conducting Mock FDA Style Audit 16 May 2017, E&O Hotel, Penang Trainer: Ms Linda Chatwin No of participants: 80 No of organisations: 24

Risk Management for Medical Devices (EN ISO 14971: 2012) 25-26 July, Dorsett Grand Subang Trainer: Mr Harry Wong, Ansell Total no of participants: 28 Total no of organisations: 17

AMMI ANNUAL REPORT 2017

TALENT DEVELOPMENT AMMI PUBLIC TRAINING

ISO13485: 2016 Internal Auditing 17-18 May, E&O Hotel, Penang Trainer: Mr Tony Low No of participants: 20 No of organisations: 10

Medical Device Manufacturing Process Validation 13-14 September, Dorsett Grand Subang Trainer: Gobu Devarajan, Ansell No of participants: 31 No of organisations: 14

Medical Device Packaging 26 September, G Hotel Gurney, Penang Trainer: Chris Osborn, Bemis USA Total no of pax: 41 Total no of companies: 13

AMMI ANNUAL REPORT 2017

TALENT DEVELOPMENT AMMI PUBLIC TRAINING

21 CFR Part 820 30-31 October, E&O Hotel, Penang Trainer: Mr Frank Ried, Ried Q&C Consulting Total no of pax: 17 Total no of organisations: 8

Industrial Sterilization of Medical Devices 15-16 November, E&O Hotel, Penang Trainers: Richard Cowman and Jayanthimala A, STERIS Total no of pax: 42 Total no of organisations: 16

Medical Device Manufacturing Process Validation 23-24 November, G Hotel Gurney, Penang Trainer: Gobu Devarajan, Ansell Total no of pax: 47 Total no of organisations: 12

AMMI ANNUAL REPORT 2017

REGULATORY & TECHNICAL

AMMI Regulatory Affairs Group Meeting and Dialogue with MDA, 4 May 2017

KEY HIGHLIGHTS AMMI Regulatory Affairs * Dialogue with Medical Device Authority

4 MAY

Submitted Policy Paper * on Draft MS Halal Medical Devices

AMMI REGULATORY AFFAIRS GROUP MEETING & DIALOGUE WITH MEDICAL DEVICE AUTHORITY (MDA)

Active engagement with * authorities on industry

challenges in key issues such as Free Sales Certificate, Labelling Requirements, Enforcement Date by 1 January 2018 and Draft MS-Halal Medical Devices

The meeting was held at Dorsett Putrajaya and was attended by fifty-five AMMI members and invited guests (from Medical Device Authority, MATRADE, MITI and Ministry of Health). MDA was represented by CEO, Encik Zamane and top MDA officials. Key issues raised in the meeting were Registration Number on Medical Devices, Labelling Compliance Duration, Instruction For Use (IFU) for Class A & B, Date of Manufacture (DOM) and Date of Expiry (DOE), Exemption from Labelling, Certificate of Free Sales and other changes that are causing major impact to the medical device industry.

AMMI ANNUAL REPORT 2017

REGULATORY & TECHNICAL DATE

MEETING/EVENT

25 January

First Meeting of Working Group on Halal Medical Device

13 March

Second Meeting of Working Group on Halal Medical Device

4 May

AMMI Regulatory Affairs Group Meeting & Dialogue with Medical Device Authority (MDA)

16-18 May

Workshop on Development of Draft MS on Halal Medical Device

23 May

Industry Standards Committee on Medical Devices and Facilities for Healthcare (ISCR) Meeting

9 June

Submission of AMMI Collective Feedback to MDA on the medical device guidance document on conformity assessment for medical device.

14 July

MDA - Discussion of Draft Guidance for ‘Requirements for Labelling of Medical Devices.

3 Aug

MDA Meeting with Contract Manufacturers to understand various OEM models and possible contract manufacturer scenarios in Malaysia for regulatory policy development purpose

1 Aug – 30 Sept

Public Comment on Draft MS: Halal Medical Device - General Requirements

8 – 10 Aug

International Medical Device Conference (IMDC)

9 Aug

Dialogue with Minister and DG of Health during IMDC

22 Aug

MDA, AMMI and MMDA Discussion on Full Enforcement Deadline Compliance

20 Sept

First National Consultation on Draft MS: Halal Medical Device - General Requirements

AMMI ANNUAL REPORT 2017

REGULATORY & TECHNICAL DATE

MEETING/EVENT

21 September

AMMI submitted an advocacy letter to MDA on full enforcement of medical device registration by 1 January 2018 AMMI reiterates its recommendation to extend the enforcement date to 1st January 2019. Reason: Application takes a mean of 29 weeks from the time of submission to CAB until MDA certificate of approval is received. (Range of 11 to 41 weeks per application). 144 submission are still pending submission to CAB (including those with CAB scheduled). These submissions will therefore need more than the average 29 weeks to complete registration.

Policy Advocacy Medical Device Authority

Enforcement date of 1 Jan 2018 for medical device registration

AMMI Proposal

Proposed strategic approach:

Big impact to our members

Extension of 1 year to 1 Jan 2019

Appeal Letter

Minister of Health & DG of Health

MDAâ&#x20AC;&#x2122;s Meeting with Industry associations

15 Dec 2017

MDAâ&#x20AC;&#x2122;s Board Meeting

18 Dec 2017

25 September

Submission of AMMI Position Paper on the Draft MS: Halal Medical Device - General Requirements

13 October

Third Meeting of Working Group on Halal Medical Device

30 October

MDA meeting on Labelling Requirements for Medical Devices

7 November

Second National Consultation on Draft MS: Halal Medical Device - General Requirements

30 November

Forth Meeting of Working Group on Halal Medical Device

AMMI ANNUAL REPORT 2017

MEMBERSHIP Activities

AMMI Q1 PROGRESS MEETING AND CEO NETWORKING

MARCH Sixty members and guests from APACMed, Standards Malaysia, MATRADE, MIDA, MDA and MITI attended the meeting which was held at Hilton Hotel Petaling Jaya. After the progress updates, invited speakers took to the stage for presentations. Mr Fredrik Nyberg, CEO of APACMed gave a presentation on the Challenges and Oppotunities for Medical Device Industry in the Asia Pacific Region, while Mr Ridzwan Kasim, Senior Director of Standards Malaysia, briefed AMMI members on the new development of the Draft Halal Standard for Medical Devices.

MEMBERSHIP ENGAGEMENT SESSION

MARCH

AMMI organised a networking session in collaboration with MIDA at Jen Hotel, Johor. The objective of the session was to engage with medical device players in the southern region. Invited guests include Biocon Sdn Bhd, Kelpac Medical Asia Sdn Bhd, Aurum Healthcare Sdn Bhd, Bactiguard Malaysia Sdn Bhd, Ciba Vision Johor Sdn Bhd and AccoBiotech Sdn Bhd. AMMI ANNUAL REPORT 2017

MEMBERSHIP Activities

25 MAY

AMMI EXTRAORDINARY GENERAL MEETING (EGM), ANNUAL GENERAL MEETING (AGM), Q2 PROGRESS MEETING AND CEO NETWORKING

The event held at G Hotel Kelawai, Penang was attended by over thirty members. The AGM saw the retirement of Vice-Chairman, Mr Lim Bee Leong (Bemis Asia Pacific) and Treasurer, Mr Chin Hock Meng (Abbott). Mr John Ward (SteriPack Contract Manufacturing) and Mr Christophe Marque (Stereo) were elected as Vice-Chairmen, Mr H.T Eow (Abbott) as Secretary of the Board and Mr Yap Kee Keong (Texchem) as Treasurer. Mr Suwit Tunlayadechanont (STERIS), Mr Michel Van Crombrugge (Paramit) and Mr Michael Goh (Johnson and Johnson) were also elected to the Board as Directors. This was followed by the Q2 Progress meeting. Invited speaker, Mr Nishith Desai, Chair for ASEAN COE of RA committee of APACMed and Director of Quality and Regulatory of South East Asia, Medtronic Singapore, gave a presentation on “Asia Pacific Regulatory Updates“. Guests adjourned for CEO Networking after the meeting.

AMMI Q3 PROGRESS MEETING AND CEO NETWORKING

SEPTEMBER Thirty members attended the progress meeting which was held at The Gardens Hotel Midvalley, Kuala Lumpur. After the meeting, members participated in a World Cafe Workshop style session with discussion on two major topics - (1) Challenges of the proposed Draft Malaysian Standard - Halal Medical Device and (2) Strategic Approach to Local Market Access (facilitated by PEMANDU Associates). 22

AMMI ANNUAL REPORT 2017

MEMBERSHIP Activities

AMMI CEO EVENING TALK ON INDUSTRY 4.0 FOR THE MEDICAL DEVICE INDUSTRY

AUGUST

Forty-five members and guests attended the event which was held at Equatorial Hotel, Penang. The objective of this event is to provide insight and updates, as well as facilitate open discussion among top management level representatives of AMMI member companies and key stakeholders on the impending age of Industry 4.0 in the Medical Device Industry. Dr Juergen Schloesser (Senior Vice President, Operations & Head of the Centre of Excellence for Intravenous Access, B. Braun Medical Industries) gave a presentation on Industry 4.0 for the Medical Device Industry. This was followed by a panel discussion, led by Mr Martin Tonko (Roland Berger). Panel members were Dr Juergen Schloesser, Mr YJ. Lim (Regional President, Plexus APAC), Mr Michel Van Crombrugge (Country Manager, Paramit) and Mr Dave Mitchell (VP Operations, Boston Scientific).

Left to right: Mr Martin Tonko, Mr Michel Van Crombrugge, Dr Juergen Schloesser, Mr YJ. Lim and Mr Dave Mitchell AMMI ANNUAL REPORT 2017

MEMBERSHIP Activities

Q4 PROGRESS MEETING, NETWORKING COCKTAILS AND ANNUAL DINNER

DECEMBER Eighty-six AMMI members and guests attended the event which was held at Majestic Theatre in Penang. The event started with the Q4 Progress Meeting, followed by networking cocktails and dinner.

AMMI ANNUAL REPORT 2017

MEMBERSHIP Activities

7 DECEMBER

Q4 PROGRESS MEETING, NETWORKING COCKTAILS AND ANNUAL DINNER

AMMI also held an appreciation session for its Regulatory and Technical Committee, Talent Development Committee and Trainers

Yap Kee Keong, Frank Ried, Jayanthimala

AMMI ANNUAL REPORT 2017

Yap Kee Keong, Chee Wei Bee, Mohd Anwar, Cynthia Ooi

Datoâ&#x20AC;&#x2122; Dr Haminnuddin, Jason Ng, Kek Soo Ling, Gan Poh Siew, Yew Saw Peng, Muhd Juzaili

MEMBERSHIP NEW MEMBERS Biocon Sdn Bhd Biocon’s Malaysia facility, which was commissioned in 2015, started commercial operations in 2016. Biocon Malaysia is the first overseas biopharma manufacturing and research facility of Biocon Ltd., Asia’s premier biopharmaceuticals company and employs a team of nearly 550 professionals at this state-of-the-art facility. Medtronic Malaysia Sdn Bhd Medtronic Principal Executive Office located in Dublin, Ireland, is among the world’s largest medical technology companies. To meet the needs of patients and partners around the globe, Medtronic operates in more than 160 countries worldwide with more than 370 locations. At Medtronic, one of the missions is to contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life. Multivac Sdn Bhd Multivac is one of the leading providers worldwide of packaging solutions for food, life science & healthcare products as well as industrial items. The Multivac Group has approximately 5,200 employees worldwide, with nearly 1,900 of these employees based out of its headquarters in Wolfertschwenden, Germany, in more than 80 subsidiaries. PMA Manufacturing Sdn Bhd PMA was established in 2004. PMA is the World Leader in Cleanroom and Non Cleanroom Labels, Pre-Saturated Wipers, Thermal Transfer Ribbons, Tapes, and Silicon Free Liners, with four manufacturing plants located in Diamond Valley Light Industrial Estate, Penang Malaysia. Ried Q&C Consultancy Sdn Bhd Ried Q&C Consulting Sdn. Bhd. provides training, 3rd party supplier auditing, MockFDA Inspection, preparation for FDA Inspection and introduction of compliance programs, all related to compliance to EUMDR, ISO 13485 and/or 21 CFR Part 820 to Medical and Pharmaceutical. Tomoe Malaysia Sdn Bhd Tomoe is a manufacturing company of high grade EtO sterilization gas, and service provider for Sterilization Procedure such as IQ, OQ and PQ. They also can provide sterilization chamber and related products. Its head office is located in Tokyo, Japan, with not less than 50 other branches in Japan and global network in Singapore, Thailand, Vietnam, Philippine, China, Indonesia & India.

UPGRADED TO FULL MEMBERS

MEMBERSHIP TERMINATIONS

1. Boston Scientific Medical Device (Malaysia) Sdn Bhd 2. Engineered Medical Systems Sdn Bhd 3. Owen Mumford Sdn Bhd

1. Unomedical Sdn Bhd 2. Dow Corning (M) Sdn Bhd 3. Straits Orthopaedic Sdn Bhd 4. Min-Tec Sinagama, Malaysian Nuclear Agency 5. Dispo-Med (Malaysia) Sdn Bhd

AMMI ANNUAL REPORT 2017

MEMBERSHIP 2017 Amendment of AMMI Constitution Highlighted in blue are the major changes to the AMMI Constitution (effective 21 July 2017)

New/Amended Rule 4.4.3 Completed application forms should be accompanied with copies of the following and each application will be approved by two (2) Directors. a) Company Profile b) ISO 9001 Certificate c) ISO 13485 Certificate d) Any other document as may be required by the Board 6.6 New members will have to pay an entrance fee of RM1,000 and an annual membership fee of RM2,000 for the first year. During the first year interim period, new members will not have voting rights. Upon completion of the (one) 1 year term, the membership category will be reviewed by the Board of Directors. In any event, the decision on the category of membership is at the discretion of the Board of Directors. 7.5 An extraordinary general meeting of the Association shall be convened: a) Whenever the Board of Directors deems it desirable, or b) At the joint request in writing of a minimum of one third of the number of Full Members stating the objects and reasons for such meeting 8.4 (c) The members of the Board shall endeavour to agree among themselves who shall retire each Year, failing which, those to retire shall be those have been longest in office since their last election. 8.4 (d) The election of the Board of Directors will be by way of ballot of the voting members present at the General Meeting or by proxy in writing. The instrument appointing a proxy and any authority under which it is executed or in some other manner approved by the Board, and shall be delivered to AMMI Secretariat Office by electronic means or such other place as it specified in the notice convening the General Meeting or in any instrument of proxy sent out by AMMI in relation to the General Meeting not less than forty-eight (48) hours before the time for holding the General Meeting or adjourned General Meeting at which the person named in the instrument proposes to vote, and an instrument of proxy which is not delivered in a manner so permitted shall be invalid unless the Board of Directors determines otherwise. 8.4 (e) The Board of Directors on being elected in accordance with the Constitution herein shall elect Executive Office Bearers among themselves following the Annual General Meeting in accordance with such rules and regulations as may be approved by the Board of Directors from time to time. 8.4 (f) If any of the Executive Office Bearers resigns during his/her term, the Board can fill up the vacancies by appointing any of the Board members to fill up the vacancies. 8.4 (g) The Board of Directors may co-opt members into the Board to fill up vacancies of the Board at any time following an Annual General Meeting and the term of the such co-opted members of the Board shall expire at the next Annual General Meeting. 8.7 The meeting of the Board of Directors shall be held at such time and place as the Board of Directors may from time to time direct, or falling such direction as the Chairman, or in his absence, a Vice Chairman may decide. Such meeting shall take place once in every three (3) months, at least one half of the Board members must be present for its proceeding to be valid and to constitute a quorum. The quorum for the transaction of the business of the Board may be fixed by the Board and where deemed fit, subsequently varied from time to time; but where it has not been so fixed, shall be a majority of the incumbent members of the Board. Questions arising at a meeting of the Board shall be decided by a majority of those present at the meeting. In the case of an equality of votes, the Chairman of the Board shall have a second or casting vote. AMMI ANNUAL REPORT 2017

AMMI MEMBERS’ DIRECTORY FULL MEMBERS

DETAILS

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 Country of Origin: USA Website: www.3M.com

St. Jude Medical Operations (Malaysia) Sdn. Bhd. St Jude Medical is now Abbott Plot 102, Lebuhraya Kampung Jawa, 11900 Bayan Lepas Industrial Zone, Penang, Malaysia. Tel: 04-810 1000 Fax: 04-810 1001 Country of Origin: USA Website: www.sjmglobal.com

Ain Medicare Sdn Bhd Jalan 6/44, Kawasan Perindustrian Pengkalan Chepa 2, Kota Bharu 16100, Kelantan, Malaysia. Tel: 09-7743 388 Fax: 09-7742 205 Country of Origin: Malaysia Website: www.ainmedicare.com.my

Allen Healthcare Products (M) Sdn Bhd 17, Lorong Nagasari 2, Taman Nagasari, 13600, Perai, Penang, Malaysia. Tel: 604-3901168 Fax: 604-3831334 Country of Origin: Malaysia Website: www.ahpmy.com

Ambu Sdn Bhd Lot 69B , Lintang Bayan Lepas 6, Phase IV, 11900 Penang, Malaysia. Tel: 604-252 9000 Fax: 604-644 8932 Country of Origin: Denmark Website: www.ambu.com

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 Country of Origin: Australia Website: www.ansell.com

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 Country of Origin: Australia Website: www.apsmedical.com.au

Bard Sdn Bhd Lot 57C, Lorong Perusahaan 5, Kulim Industrial Estate, 09000 Kulim, Kedah, Malaysia. Tel: 604-4801300 Fax: 604–4891737 Country of Origin: USA Website: www.crbard.com

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 Country of Origin: Germany Website: www.bbraunap.com

10.

Bemis Asia Pacific Sdn Bhd Lot 823, Jalan Subang 5, Taman Perindustrian Subang USJ 1, 47600 Subang Jaya, Selangor, Malaysia. Tel: 603-8021 0998 Fax: 603-8021 0000 Country of Origin: UK Website: www.bemis.com

11.

Boston Scientific Medical Device (Malaysia) Sdn Bhd PMT 741, Persiaran Cassia Selatan 1, Taman Perindustrian Batu Kawan 14100, Bandar Cassia, Penang, Malaysia. Tel: 604-5556688 Fax: 604-5556699 Country of Origin: USA Website: www.bostonscientific.com

12.

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 Country of Origin: USA Website: www.cardinalhealth.com

AMMI ANNUAL REPORT 2017

AMMI MEMBERSâ&#x20AC;&#x2122; DIRECTORY FULL MEMBERS

DETAILS

13.

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 Country of Origin: Malaysia Website: www.diptech.com.my

14.

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 Country of Origin: USA Website: www.dupont.com

15.

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 Country of Origin: Malaysia Website: www.EngMedSys.com

16.

Epsilon Medical Devices Sdn Bhd Lot 5271, Jalan Perusahaan 3, Kamunting Industrial Estate, 34600 Kamunting, Perak, Malaysia. Tel: 605-8913158 Fax: 605-8911266 Country of Origin: Malaysia Website: www.epsilon-group.com

17.

Fresenius Medical Care Production Sdn Bhd Lot 34618, PT29466, Bandar Enstek, Mukim Labu, 71760 Bandar Enstek, Negeri Sembilan, Malaysia. Tel : 606-791 5334 Fax: 606-791 5336 Country of Origin: Germany Website: www.fmc-my.com

18.

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 Country of Origin: Malaysia Website: www.gmmi-med.com

19.

Haemonetics Malaysia Sdn Bhd PMT727, Persiaran Cassia Selatan 1, Taman Perindustrian Batu Kawan, 14100 Simpang Ampat, Seberang Perai Selatan, Penang, Malaysia. Tel: 604-503 5141 Country of Origin: USA Website: www.haemonetics.com

20.

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 Country of Origin: Malaysia Website: www.hospitech.net

21.

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 Country of Origin: Malaysia Website: www.idealcare.com.my

22.

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 Country of Origin: Australia Website: www.itl-limited.com

23.

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 Country of Origin: USA Website: www.jnj.com

24.

KLS Martin Malaysia Sdn Bhd No. 1193, Lorong Perindustrian Bukit Minyak 11, Taman Perindustrian Bukit Minyak, 14100 Simpang Ampat, Penang, Malaysia. Tel: 604-506 2380 Fax: 604-506 2303 Country of Origin: Germany Website: www.klsmartin.com

AMMI ANNUAL REPORT 2017

AMMI MEMBERSâ&#x20AC;&#x2122; DIRECTORY FULL MEMBERS

DETAILS

25.

Lake Region Medical Sdn Bhd No. 91-B, Lebuhraya Kampung Jawa, 11900 Bayan Lepas, Penang, Malaysia. Tel: 604-810 1818 Fax: 604-643 1232 Country of Origin: USA Website: www.lakeregionmedical.com

26.

Medipro Malaysia Sdn Bhd Lot 15, Lebuh Hishamuddin 3, Kaw. 20, Bandar Sultan Sulaiman, 42000 Port Klang, Selangor, Malaysia. Tel: 603-3176 3446 Fax: 603-3176 4229 Country of Origin: Japan Website: www.medipro.com.my

27.

Mediquip Sdn Bhd Padang Lati, Mukim Paya, P.O. Box 25, 01700 Kangar, Perlis, Malaysia. Tel: 604-938 1411 ext: 222 Fax: 604-938 2150 Country of Origin: USA

28.

Meditop Corporation (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 Country of Origin: Japan Website: www.top-tokyo.co.jp

29.

Molnlycke Health Care Sdn Bhd Lot 9 Lorong Perusahaan 4, Kulim Industrial Estate, 09000 Kulim, Kedah, Malaysia. Tel: 604-489 1819 Fax: 604-489 1220 Country of Origin: Sweden Website: www.molnlycke.com

30.

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 Country of Origin: UK Website: www.bioclean.com

31.

Orthomedic Innovations Sdn Bhd 188-D, Jalan Sultan Azlan Shah, Sungai Tiram, 11900 Bayan Lepas, Penang, Malaysia. Tel: 604-644 5139 Fax: 604-6449139 Country of Origin: Malaysia Website: www.orthomedic.com.my

32.

Owen Mumford Sdn Bhd No. 21, Jalan Bioteknologi 3, Kawasan Perindustrian SiLC, Nusajaya, 79200 Johor, Malaysia. Tel 607-5539617 Fax 607-5539617 Country of Origin: UK Website: www.owenmumford.com/en

33.

Paramit Malaysia Sdn Bhd PMT 1199, Penang Science Park, Lorong Perindustrian Bukit Minyak 21, 14100 Simpang Ampat, Seberang Perai Tengah, Penang, Malaysia. Tel: 604-540 7000 Fax: 604-5407111 Country of Origin: USA Website: www.paramit.com

34.

Prent Malaysia Sdn Bhd PTD102587, Jalan Cyber 14, Senai Industrial Park IV, 81400 Senai, Johor, Malaysia. Tel: 607-599 7661 Fax: 607-599 7660 Country of Origin: USA Website: www.prent.com.my

35.

Sanmina-SCI Systems (Malaysia) Sdn Bhd Plot 202, Lorong Perusahaan Maju 9, Bukit Tengah Industrial Estate, 13600 Perai, Penang, Malaysia. Tel: 604-5081228 Fax: 604-5081233 Country of Origin: USA Website: www.sanmina.com

36.

Sin Yong Guan Industries Sdn. Bhd. 8 Solok Rishah 2, Kwsn Perindustrian Silibin, 30100 Ipoh, Perak, Malaysia. Tel: 605-526 7231 Fax: 605-526 8491 Country of Origin: Malaysia Website: www.syg53.com

AMMI ANNUAL REPORT 2017

AMMI MEMBERSâ&#x20AC;&#x2122; DIRECTORY FULL MEMBERS

DETAILS

37.

Star Medik Sdn Bhd No.43. Jalan Tiara Sentral 2, Nilai Utama Enterprise Park, 71800, Nilai, Negeri Sembilan, Malaysia. Tel: 603-8706 5282/2934 Fax: 603-8706 5805 Country of Origin: Malaysia Website: www.starmedik.com.my

38.

Stereo Sdn Bhd 37, Lorong Sungai Puloh 1A/KU6, Taman Teknology Gemilang, Kawasan Perindustrian Sungai Puloh, 41050 Klang Selangor, Malaysia. Tel: 603-3290 2263 Fax: 603-3290 2016 Country of Origin: Malaysia Website: www.stereocorp.com

39.

SteriPack Contract Manufacturing PT119992, Jalan Canang Emas 8, Telok Gong, 42000 Klang, Selangor, Malaysia. Tel: 03-3167 3596 Fax: 03-3167 3597 Country of Origin: Ireland Website: www.steripackgroup.com

40.

Symmetry Medical Malaysia Sdn Bhd Plot 80C, Kawasan Perusahaan Bayan Lepas, 11900 Bayan Lepas, Penang, Malaysia. Tel: 604-645 6802 Fax: 604-6445805 Country of Origin: USA Website: www.tecomet.com

41.

Synergy Sterilisation (M) Sdn Bhd (now part of STERIS) Plot 203 Kuala Ketil Industrial Estate, 09300 Kuala Ketil, Kedah, Malaysia. Tel: 604-415 2111 Fax: 604-415 2121 Country of Origin: U.S. Website: www.steris-ast.com

42.

Teleflex Medical Sdn Bhd Lot No PT2577, Jalan Perusahaan 4 Kamunting, 34600 Kamunting Perak, Malaysia. Tel: 605-891 5111 Fax: 605-891 2699 Country of Origin: USA Website: www.teleflexmedical.com

43.

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 Country of Origin: Japan Website: www.texchem-pack.com

44.

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 Country of Origin: Malaysia Website: www.topglove.com

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 Country of Origin: Malaysia Website: www.uwcholdings.com

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 Country of Origin: Malaysia Website: www.vigilenzmd.com

47.

Worldwide Medivest Sdn Bhd No. 2, Jalan Karyawan 4/KU7, Lorong Sg Puloh, Taman Kapar Bestari, Kapar 42200, Selangor, Malaysia. Tel: 03-3291 2625 Fax: 03-3291 2725 Country of Origin: Malaysia Website: www.wmsb.com.my

48.

Zeito Plastics Components Sdn Bhd Lot 19-6, Bersatu Industrial Complex, Jalan CJ1/1, Cheras Jaya, 43200 Cheras, Selangor Darul Ehsan, Malaysia. Tel: 03-9074 9177 Fax: 03-9074 9096 Country of Origin: Malaysia Website: www.zeito.com.my

AMMI ANNUAL REPORT 2017

AMMI MEMBERS’ DIRECTORY ASSOCIATE MEMBERS DETAILS 1.

Becton Dickinson Sdn Bhd Unit 24, LG 5 (Executive Wing), Hotel Equatorial Penang, 1 Jalan Bukit Jambul, 11900 Bayan Lepas, Penang, Malaysia. Tel: 604-640 5688 Fax: 604-640 5686 Country of Origin: USA Website: www.bd.com/my/

BillerudKorsnäs AB C/O: Lot D12-11,Mutiara Oriental Condo, Jalan BM 1/8, Taman Bukit Mayang Emas, 47301 Petaling Jaya, Selangor, Malaysia. Tel: 603-7806 1219 Fax:603-7806 1219 Country of Origin: Sweden Website: www.billerudkorsnas.com

Biocon Sdn Bhd No.1 Jalan Bioteknologi 1, Kawasan Perindustrian SILC, 15 Bandar Puteri Johor, 79200, Johor, Malaysia. Tel: 607-560 0000 Fax: 607-560 0098 Country of Origin: India Website: www.biocon.com

Cochlear Malaysia Sdn Bhd Unit UG1, Upper Ground Floor, Vertical Podium, Avenue 3, Bangsar South, No.8, Jalan Kerinchi, 59200 Kuala Lumpur, Malaysia. Tel: 603-22823839 Fax: 603-22823839 Country of Origin: Australia Website: www.cochlear.com

Medtronic Malaysia Sdn Bhd B-23-1, The Ascent, Paradigm, No 1 Jalan SS7/26A, Kelana Jaya, 47301, Petaling Jaya, Selangor, Malaysia. Tel: 603-78838000 Fax: 603-78860474/4702 Country of Origin: Ireland Website: www.medtronic.com

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 Country of Origin: China Website: www.miramedsource.com

Multivac Sdn Bhd Lot 10-E, Pusat Teknologi Sunsuria, Jalan Teknologi, Taman Sains Selangor, Kota Damansara 47810 Petaling Jaya, Selangor, Malaysia. Tel: 603-6151 9885 Fax: 603-6143 6885 Country of Origin: Germany Website: www.multivac.com

Plastic STC Sdn Bhd No 7 Jalan TSB 9, Taman Industri Sg Buloh, 47000 Sungai Buloh, Selangor, Malaysia. Tel: 603-61575313 Fax: 603-61575318 Country of Origin: Malaysia Website: www.hlhightech.com

PMA Manufacturing Sdn Bhd No. 11, Lintang Beringin 2, Diamond Valley, 11960 Georgetown, Penang, Malaysia. Tel: 604-6261518 Fax: 604-6265253 Country of Origin: Malaysia Website: www.pmaasia.com

10.

Professional Tools & Dies Sdn Bhd 7118,Jalan Mak Mandin, Kawasan Perindustrian Mak Mandin, 13400 Butterworth, Penang, Malaysia. Tel: 604-332 2335 Fax: 604-331 2337 Country of Origin: Malaysia Website: www.professional-tools.com

11.

Ried Q&C Consulting Sdn Bhd 18, Lorong Lembah Permai 4, 11200 Tanjung Bungah, Penang, Malaysia. Tel: 6012-5617005 Fax : 604-8999105 Country of Origin: Malaysia Website: www.ried-qcc.de

12.

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 Country of Origin: Denmark Website: www.jacob-holm.com

AMMI ANNUAL REPORT 2017

AMMI MEMBERSâ&#x20AC;&#x2122; DIRECTORY ASSOCIATE MEMBERS DETAILS 13.

Tako Astatic Technology Sdn Bhd 15 Jalan Kesuma 2/2, Bandar Tasik Kesuma, Beranang, 43700 Selangor, Malaysia. Tel: 603-87238843 Fax: 603-87238844 Country of Origin: Malaysia Website: www.tako.com.my

14.

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 Country of Origin: Japan Website: www.terumo.com

15.

Tomoe Malaysia Sdn Bhd Lot 13, Jalan Kulim Hi-Tech 13 Kulim Hi Tech Park Phase 3 Kulim, Kedah 09000 Malaysia. Tel: 604-492 4101 Fax: 604-492 4202 Country of Origin: Japan Website: www.tomoeshokai.co.jp

16.

Varian Medical Systems (M) Sdn Bhd Suite B-15-5, Wisma Pantai, Plaza Pantai, No. 5, Jalan 4/83A, Off Jalan Pantai Baru 59200, Kuala Lumpur, Malaysia. Tel: 603-2296 7600 Fax: 603-2296 7601 Country of Origin: Malaysia Website: www.varian.com

AMMI ANNUAL REPORT 2017

AMMI IN THE NEWS

News

Highlight

Bright prospects for medical device sector, but more talent needed The Edge Financial Daily, 7 August 2017

Malaysiaâ&#x20AC;&#x2122;s medical devices export to grow 12 pct for 2017 Malay Mail Online, 2 August 2017

Medical devices export to grow by 12 per cent for 2017 The Borneo Post, 3 August 2017

Medical Device Manufacturers Procure Over 60% of Raw Materials and Services Locally Bernama News, 2 August 2017

Eksport peralatan perubatan diunjur meningkat 12 peratus Utusan Malaysia, 2 August 2017

Export of medical device to reach RM17.7b, says AMMI The Malaysian Reserve, 2 August 2017

Local medical industry players to invest RM1.4b this year New Straits Times, 2 August 2017

Malaysiaâ&#x20AC;&#x2122;s medical device exports to increase to RM17.74b this year, says association The Edge Markets, 2 August 2017 AMMI ANNUAL REPORT 2017

(R.O.S. Registration No. PPM-05-07-19031992)

Association of Malaysian Medical Industries (AMMI) c/o Medsociate Sdn Bhd Level 32 Menara Prestige, No. 1 Jalan Pinang, 50450 Kuala Lumpur, Malaysia. Tel: +6010 4040 662 Fax: +603 2178 4347 Email: secretariat@ammi.com.my Registered Office c/o Fastrack Corporate Sdn Bhd 51-13-A Menara BHL Bank, Jalan Sultan Ahmad Shah, 10050 Penang.

www.ammi.com.my

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