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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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Hong Kong Refines Medical Device Post-Market Surveillance Report Form
/in Hong Kong, Latest Updates/by Albert PranotoOn December 29th, 2022, the Hong Kong Medical Device Division refined and updated their Post-Market Surveillance Report form.
Thailand FDA Provides Guidance on Classification of Physical Therapy Devices
/in Latest Updates, Thailand/by Noi SuwannabotOn December 3rd, 2022, the Thailand FDA (TFDA) issued new regulation to re-classify Physical Therapy Devices as Class 1 medical devices.
Philippines FDA Issues Advisory Reiteration Against Unethical Business Practices
/in Latest Updates, Philippines/by Charmaine RosonOn December 29th, 2022 the Philippines FDA (PFDA) issued an advisory reiteration concerning unethical business practices, specifically in regards to companies that sell/manufacture Prescription Pharmaceutical Products and Medical Devices (PPPMD) and their relationship/interaction with healthcare professionals (HCPs).
Indonesia e-Catalogue Implementation Review, December 2022
/in Indonesia, Latest Updates/by Ilham HidayattulahOn April 7th, 2022, the Indonesian Ministry of Health announced a new open enrollment policy allowing manufacturers to list sales prices much easier. Under the new process, listings are accepted upon submission and published online as soon as the next day.
The Vietnamese MOH Issues Draft Decree to Address Delays
/in Latest Updates, Vietnam/by David VoOn November 15th, the Vietnamese Ministry of Health (MOH) issued a draft decree to amend a number of articles from a previous decree related to the registration of medical devices.
Thailand FDA Publishes Guidance for Software as Medical Device
/in Latest Updates, Thailand/by Noi SuwannabotOn December 12th, the Thai FDA published guidance to assist with the determination of medical device status and risk classification for medical device software in Thailand.
China NMPA Updates Compulsory Standards for Medical Devices
/in China, Latest Updates/by Bryan GilburgOn November 18th, 2022, the China NMPA released updated medical device compulsory standards covering a wide variety of medical devices, a list of which can be found on the National Institute for Food and Drug Control. While the NMPA often releases new standards for medical devices, the recent update is particularly comprehensive, with nearly every kind of device affected in the next year.
China NMPA Updates Classification of Sodium Hyaluronate Products
/in China, Latest Updates/by Bryan GilburgOn November 10th, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.