A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.
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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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.
On January 1, 2024, India’s CDSCO released a notice announcing the roll-out of the NSWS.
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.
On October 31st, 2022, China’s NMPA published a Classification Catalogue adjustment for public comment.
Manufacturers looking to Southeast Asia to help grow their medical device sales should become familiar with the Common Submission Dossier Template, or “CSDT.”
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.
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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