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Philippines Gets Moving On Reg Reform: Asian Medtech Associations Regulatory Networking, October 2018

 
• By Ashley Yeo

The Asian Medtech Associations Regulatory Networking discussions this month focus on regulatory reforms in the Philippines, where good progress is being made on embedding a new set of medical device, IVD and labeling regulations. Also, updates from Thailand, Hong Kong and India. This series is hosted by Medtech Insight, along with the Asia Regulatory and Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).

Flag of Philippines files against a lightly clouded blue sky

Key Takeaways

  • Three pieces of central medtech regulation are underway or in circulation in the Philippines, two of which align with the ASEAN Medical Devices Directive.

  • A draft medtech law in Thailand is now available in English.

  • India gets serious about full-structure medtech regulations.

The Philippines FDA has issued a new medical devices regulation, which includes the revised requirements for compliance with the ASEAN Medical Devices Directive (AMDD), using the Common Submission Dossier Template...

The industry is looking to implement the new rules in early April 2019, when all previously-unregistered devices will need to use the new regulatory pathway. Class A (low-risk) devices will...

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