A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.

Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea

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An outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.

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Hong Kong Refines Medical Device Post-Market Surveillance Report Form

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On December 29th, 2022, the Hong Kong Medical Device Division refined and updated their Post-Market Surveillance Report form.

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An Introduction to GeM, India’s Online Portal for All Public Hospital Purchases  

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In 2016 the Indian government launched an online portal, the Government e-Marketplace (commonly referred to as GeM) under the Ministry of Commerce and Industry to provide for efficient and transparent procurement by government agencies across the country.

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Bangladesh LAUNCHES NEW MEDICAL DEVICE REGULATIONS

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On September 18, 2023, The Directorate General of Drug Administration (DGDA) published the Drug and Cosmetics Act 2023 formalizing the regulatory requirements of medical and diagnostic devices in Bangladesh with immediate effect.  A translated version of the document is available on Asia Actual’s website here.  All medical devices now require a Marketing Authorization Certificate to clear Customs and be sold on the market in Bangladesh.

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CDSCO Issues Updates to IVD Classification List in India

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The Central Drugs Standard Control Organisation (CDSCO) of India issued a notice (PDF) on October 25, 2023 classifying in-vitro diagnostic (IVD) medical devices under medical device rules. The updates to IVD classification in India include intended use, associated risk, and other parameters.

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China to Accept Foreign Generated Test Reports

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This adjustment will not only make the registration process cheaper and quicker for many manufacturers, it will also improve the efficiency of China’s labs to perform testing for domestic manufacturers and other devices that will still need in-country testing. While the regulatory burden for what the NMPA will consider as acceptable self-test reports is still high, this change provides manufacturers with more options.

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MDD Issues Guidance on Making Changes to Medical Device Licenses in Hong Kong

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On November 30th, the Hong Kong Medical Device Division (MDD) issued formal guidance on the requirements to make changes to medical device licenses registered in the Medical Device Administrative Control System (MDACS).

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India Grants Import License Grace Period for Class C/D Devices

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On October 12, 2023, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2023-DC (344), granting a grace period for Import Licenses to qualifying Non-Regulatory Class C and D medical devices.

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Indonesia to Require Post-Market In-Country Testing of Medical Devices

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Indonesia’s Ministry of Health announced that as of September 2023 certain medical devices will require post-market in-country product testing. While the Ministry of Health explained that initially there is no compulsion to carry out the testing currently, there are rewards for doing so.

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Thai FDA Drafting New Guidance for SaMD and AI Device Registration

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Thai FDA is drafting new guidelines for AI Regulation. The novel characteristics of artificial intelligence (AI) software cause issues with the medical device registration process in most countries. The Thai Food and Drug Administration (Thai FDA) is working to address this important issue, most recently by hosting a meeting with interested parties on July, 2023, which Asia Actual Thailand employees were invited to attend.

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