Longitude Prize Sprint Fact Sheet Workshop 1, Friday 7 August 2020
Navigating MedTech Regulation Pathways in Developed and Emerging Markets
Follow up resources Africa and WHO
Longitude Prize resources page, in particular the following materials
• WHO: In vitro diagnostics and laboratory technology: guidance for manufacturers
• How to bring IVDs to market in Europe - a guide to new EU Regulations • Developing a Product Commercialisation Plan • How to reach the level of development to win the Prize
UK and EU • European Commission Medical Device Coordination Group Guidance • EU 2017/746 on in vitro diagnostic medical devices
Resources from Robyn Meurant’s talk
Resources from Dr Gill Morgan’s talk
US
India
• AST Special Controls Guidance
• Ministry of Health and Family Welfare - Medical Device Definition
• Coordinated Development Guidance • Coordinated Development Guidance Docket • CDC & FDA Antimicrobial Resistant Isolate Bank • FDA and 21st Century Cures Resources from Dr Sally A. Hojvat and Dr Steven Gitterman’s talk
Middle East and North Africa • WHO: Regulatory Collaboration Principles In GCC States • WHO: Medical Devices regulations global overview and guiding principles • WHO: Harmonization of Regulation – Challenges and Benefits • Asian Harmonization Working Party
• ICMR DCGI: Guidelines for Validation and Batch Testing of Covid-19 Diagnostic Kits
• International Medical Device Regulators Forum
• ICMR Diagnostic Kits Evaluation
• IMDRF: Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’
• CDSCO notice on Covid-19
• IMDRF: Principles of Medical Devices Classification
• CDSO: FAQs on Medical Device Rule
• IMDRF: Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices • IMDRF: Principles of Conformity Assessment for Medical Devices • Saudi Food and Drug Authority - Medical Devices Resources from Lakshman Balajepalli’s talk
Resources from Dr Malathi Laxmikumaran’s talk
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