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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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Taiwan’s New TCP III in Effect as of January 1, 2022
/in Latest Updates, Taiwan/by Eric LeungThe Taiwan FDA implemented the third generation of the Taiwan-Europe Technical Cooperation Program (TCP III) on January 1, 2022.
Hong Kong to Pilot Prioritizing Some Listed Medical Devices
/in Commercial Services, Hong Kong, Latest Updates/by Eric LeungHong Kong’s MDD announced the start of a pilot program that will give preference to MDACS listed medical devices.
How New EU MDR Requirements Will Affect Registrations in Asia
/in China, Hong Kong, India, Indonesia, Latest Updates, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam/by Bryan GilburgAs manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.
Thai FDA Implements Initial Screening Step to Submission Process
/in Latest Updates, Thailand/by Bryan GilburgBeginning August 1st, 2022, the Thai FDA implemented a new screening submission process applicable to almost all applications.
Indonesia Issues New Guidance for Freezing Medical Devices on eCatalogue
/in Indonesia, Latest Updates/by Ilham HidayattulahOn July 6, 2022, the Ministry of Health released updated guidance outlining the process for freezing medical device categories on the eCatalogue,
Medical Device Advertising Requirements in Asia
/in Australia, China, Commercial Services, Hong Kong, India, Indonesia, Japan, Latest Updates, Malaysia, Philippines, Russia, Singapore, South Korea, Taiwan, Thailand, United States, Vietnam/by Bryan GilburgIn addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.
Registering Innovative Medical Devices in India
/in India, Latest Updates/by Gunjan VermaInnovative device (those without a registered “predicate”) registration in India can be complicated with many variations to the requirements, and options to proceed.
China Releases Draft Clinical Evaluation Exemption List for 2022
/in China, Latest Updates/by Bryan GilburgOn July 5, 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) has released their annual draft of Clinical Evaluation Exemption List.