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- 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
- Hong Kong MDD Adds China and Korea to List of Reference Countries January 29, 2024
- Thailand FDA to Decrease Registration Application Processing Times January 25, 2024
- Thailand FDA to Improve Medical Device Advertising Review Times January 22, 2024
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Indonesia to Permit Some Class A Products to Register via Notification
/in Indonesia, Latest Updates/by Ilham HidayattulahOn January 10, 2022, Indonesia’s Ministry of Health released Indonesia Class A Notification Announcement 01.05500242022 establishing a new registration route for some low risk medical devices effective immediately.
Vietnam Requires Resubmission of Many Medical Device Registration Applications
/in Latest Updates, Vietnam/by David VoAll unapproved Class B, C and D MA License applications have been returned for resubmission for compliance to the new requirements.
China to Accept Foreign Generated Test Reports
/in China, Latest Updates/by Bryan GilburgThis 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.
India Postpones Registration Requirements for Certain Medical Devices
/in India, Latest Updates/by Gunjan VermaWith the release of a new order on Nov 3, 2021, CDSCO has postponed the Import Licensing requirement for 8 categories of medical devices.
Vietnam Releases New Medical Device Regulations
/in Latest Updates, Vietnam/by David VoThe MOH officially released Decree 98/2021 ND-CP, which implements significant new changes to the medical device registration process in Vietnam.
India Launches Scheme for Promotion of Medical Device Parks
/in India, Latest Updates/by Gunjan VermaThe scheme for “Promotion of Medical Device Parks” is a key initiative to support the medical devices industry with with a financial outlay of Rs. 400 crore (~US$51 million).
Thailand Fast Tracks Class D Medical Device Registration with Singapore Approval Status
/in Latest Updates, Thailand/by Bryan GilburgThe Thai FDA has formally adopted the Regulatory Reliance Program in which Class D (Class 4 in Thailand) medical devices and IVDs listed on the Singapore Medical Device Registry can be exempted from the Specialist Review requirement in Thailand.
India’s CDSCO Updates Classification of Several Product Categories
/in India, Latest Updates/by Gunjan VermaThe updated list of the risk class of devices are based on the intended use, risk associated with Medical Devices and other In Vitro Diagnostic (IVD) Medical Devices and other parameters specified in First schedule of MDR 2017.