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

Singapore’s HSA Issues New Guidance on Special Access Routes (SAR)

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Singapore’s Health Science Authority (HSA) recently held a zoom conference call outlining the new requirements for the Special Authorization Routes GN-26 and GN-27 taking effect on April 1, 2022.

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Vietnam’s MoH Updates Class C and D Application Requirements

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Per Decree 07/2022, the application requirements for new Class C and D applications submitted to the Vietnamese Ministry of Health (MoH) after January 1, 2024 will need to be in ASEAN Common Submission Dossier Template (CSDT) format, with the addition of a Vietnamese IFU.

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India’s Class C and D Import License Enforcement Deadline Fast-Approaching

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On April 1, 2024, the Central Drugs Standard Control Organization’s (CDSCO) grace period for Non-Regulatory Class C and D medical devices in India comes to a close.

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China’s NMPA Publishes Classification Catalogue Adjustments for Comment

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On October 31st, 2022, China’s NMPA published a Classification Catalogue adjustment for public comment.

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Thai FDA QMS Updates to Affect GDP, GMP, and GCP

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Last month, the Thai FDA announced new quality systems requirements that apply to the manufacture and distribution of medical devices, and for conducting clinical trials in Thailand.

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Philippines FDA Announces New Fee Schedule for Medical Devices

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On November 29th and 30th the Philippines FDA hosted a public forum to review and field questions on plans to change the fee schedule for processing registration applications as outlined in a recent draft Administrative Order (available here) and it’s corresponding Annexes.

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Thailand FDA to Decrease Registration Application Processing Times

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The Thai FDA hosted a seminar for public discussion and training of the full CDST application, which was attended by Asia Actual Thailand personnel. At the event, the Thai FDA announced its intention to decrease the application pre-screening time from 30 days to 1 working day.

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Thailand FDA to Improve Medical Device Advertising Review Times

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In a training seminar held on January 15 and 16, 2024, by the Thai FDA on the Full Common Submission Dossier Template (CSDT), the TFDA stated their intention to improve the advertising approval process. Per the Deputy Secretary General, they plan to implement new processes meant to help expedite the approvals of advertisement applications.

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