A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.
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 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.
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.
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.
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.
On January 3, 2024, Hong Kong’s Medical Device Division (MDD) issues the Technical Reference document TR-008: Artificial Intelligence Medical Devices (AI-MD). It provides clarity for devices using AI (AI-MD) and machine learning, including Continuous Learning Capability (CLC) and the technical requirements expected for listing these medical devices on the Medical Device Administrative Control System (MDACS).
Beginning January 1, 2021, the NMPA began implementing UDI requirements in China for the first batch of 69 types of medical devices in 9 categories.
Hong Kong’s Medical Device Division has released a new technical reference document related to software medical devices (SaMD and SiMD). Released on December 29, 2023, TR-007: Software Medical Devices and Cybersecurity, aims to provide more clarity for Software in a Medical Device (SiMD) and standalone software (Software as a Medical Device (SaMD)), specifically related to definitions, classification and cybersecurity.
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