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- Australia’s SaMD Regulatory Deadline April 16, 2024
- Thai FDA Regulatory Documentation Exemptions April 12, 2024
- Hong Kong MDD Adds Singapore as Reference Country April 4, 2024
- Philippines Incentivizing Local Medical Device Manufacturing March 19, 2024
- China’s Third Batch of UDI Implementation Deadline in June March 15, 2024
- Thai FDA Reduces Application Review Time March 13, 2024
- Vietnam’s MoH Updates Class C and D Application Requirements February 29, 2024
- India Changes Medical Device Application Processing System February 27, 2024
- India’s Class C and D Import License Enforcement Deadline Fast-Approaching February 20, 2024
- Thai FDA QMS Updates to Affect GDP, GMP, and GCP February 14, 2024
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India’s Class C and D Import License Enforcement Deadline Fast-Approaching
/in India, Latest Updates/by Gunjan VermaOn 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.
Thai FDA QMS Updates to Affect GDP, GMP, and GCP
/in Latest Updates, Thailand/by Noi SuwannabotLast 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.
Hong Kong MDD Adds China and Korea to List of Reference Countries
/in Hong Kong, Latest Updates/by Bryan GilburgStarting January 1st, 2024, the Hong Kong Medical Device Division (MDD) accepts, on a regular basis, the marketing approvals obtained from the National Medical Products Administration (NMPA) of Mainland China and the Ministry of Food and Drug Safety (MFDS) of Korea as support of compliance of the medical device to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) under MDACS.
Thailand FDA to Decrease Registration Application Processing Times
/in Latest Updates, Thailand/by Noi SuwannabotThe 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.
Thailand FDA to Improve Medical Device Advertising Review Times
/in Latest Updates, Thailand/by Noi SuwannabotIn 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.
Hong Kong MDD Issues New Technical Reference Document for AI-MD
/in Hong Kong, Latest Updates/by Bryan GilburgOn 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).
Hong Kong MDD Issues Technical Reference for SaMD and SiMD
/in Hong Kong, Latest Updates/by Bryan GilburgHong 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.
Philippines FDA Announces New Fee Schedule for Medical Devices
/in Latest Updates, Philippines/by Charmaine RosonOn 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.