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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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MDD Issues Guidance on Making Changes to Medical Device Licenses in Hong Kong
/in Hong Kong, Latest Updates/by Albert PranotoOn November 30th, the Hong Kong Medical Device Division (MDD) issued formal guidance on the requirements to make changes to medical device licenses registered in the Medical Device Administrative Control System (MDACS).
CDSCO Issues Updates to IVD Classification List in India
/in India, Latest Updates/by Gunjan VermaThe Central Drugs Standard Control Organisation (CDSCO) of India issued a notice (PDF) on October 25, 2023 classifying in-vitro diagnostic (IVD) medical devices under medical device rules. The updates to IVD classification in India include intended use, associated risk, and other parameters.
Embracing Innovation and Collaboration: Highlights from the 15th CII Global MedTech Summit
/in India, Latest Updates/by Gunjan VermaOn October 6, 2023, a team of enthusiastic members from the AAI (Artificial Intelligence and Innovation) group, including Ashoniya Puri, Sanjay Singh, and Rajat Budhori, had the honor of attending the prestigious 15th CII Global MedTech Summit. Hosted by the Confederation of Indian Industry (CII), one of India’s largest industry bodies, this event brought together key players in the MedTech sector, both from India and abroad. The summit revolved around the central theme, “Paving the way for a USD 50 billion MedTech Industry by 2030,” signifying a collective vision for the industry’s future growth.
Bangladesh LAUNCHES NEW MEDICAL DEVICE REGULATIONS
/in Bangladesh, Latest Updates/by Albert PranotoOn September 18, 2023, The Directorate General of Drug Administration (DGDA) published the Drug and Cosmetics Act 2023 formalizing the regulatory requirements of medical and diagnostic devices in Bangladesh with immediate effect. A translated version of the document is available on Asia Actual’s website here. All medical devices now require a Marketing Authorization Certificate to clear Customs and be sold on the market in Bangladesh.
India Grants Import License Grace Period for Class C/D Devices
/in India, Latest Updates/by Gunjan VermaOn October 12, 2023, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2023-DC (344), granting a grace period for Import Licenses to qualifying Non-Regulatory Class C and D medical devices.
Indonesia to Require Post-Market In-Country Testing of Medical Devices
/in Indonesia, Latest Updates/by Ilham HidayattulahIndonesia’s Ministry of Health announced that as of September 2023 certain medical devices will require post-market in-country product testing. While the Ministry of Health explained that initially there is no compulsion to carry out the testing currently, there are rewards for doing so.
China’s NMPA Updates Medical Device Classification Catalogue
/in China, Latest Updates/by Albert PranotoChina’s National Medical Products Administration (NMPA) maintains a list of all medical device categories called the Medical Device Classification Catalogue. NMPA published a notice on August 17, 2023, that they had released amendments to the Medical Device Classification Catalogue. It’s important for manufacturers to understand these changes as they can significantly impact the cost and time to register medical devices.
Thai FDA Drafting New Guidance for SaMD and AI Device Registration
/in Latest Updates, Thailand/by Noi SuwannabotThai FDA is drafting new guidelines for AI Regulation. The novel characteristics of artificial intelligence (AI) software cause issues with the medical device registration process in most countries. The Thai Food and Drug Administration (Thai FDA) is working to address this important issue, most recently by hosting a meeting with interested parties on July, 2023, which Asia Actual Thailand employees were invited to attend.