Monday, 2, March, 2026 / Published in China, IVDs, Medical Devices, News

China NMPA Issues 2026 Medical Device Industry Standards Development and Revision Plan

On February 11, 2026, the National Medical Products Administration (NMPA) published “Notice on Issuing the 2026 Medical Device Industry Standards…

Wednesday, 11, February, 2026 / Published in Blog, Indonesia, IVDs, Medical Devices

Medical Device Registration in Indonesia: A Practical Guide for Foreign Manufacturers

Medical device registration in Indonesia is rarely “just paperwork” for foreign manufacturers. Early regulatory choices can lock in, or limit,…

Thursday, 5, February, 2026 / Published in Blog, China, IVDs, Medical Devices

Medical Devices in China: A Regulatory Glossary for NMPA Compliance

Entering the market for medical devices in China rarely feels like a simple extension of a US FDA or EU…

Thursday, 29, January, 2026 / Published in China, IVDs, Medical Devices, News

China NMPA Clears 104 Innovative Medical Devices for Special Review in 2025

In 2025, China’s National Medical Products Administration (NMPA), through its Center for Medical Device Evaluation (CMDE), released 12 batches of…

Friday, 16, January, 2026 / Published in Hong Kong, IVDs, News, Pharma & Biotech

Hong Kong Launches Pre-NDA Meetings Under the “1+” Drug Registration Mechanism

The Department of Health (DH) announced the operational launch of Pre-New Drug Application (Pre-NDA) meetings on December 22, 2025. This…

Thursday, 15, January, 2026 / Published in Hong Kong, IVDs, Medical Devices, News

Hong Kong DH Mandates Medical Device Listing for Public Procurement by March 2026

On December 18, 2025, the Hong Kong Department of Health (DH) announced the formal implementation of Stage C under its…

Tuesday, 30, December, 2025 / Published in China, IVDs, Medical Devices, News

China Medical Device Imports Remain Stable in H1 2025

China’s medical device import market demonstrated continued stability in the first half of 2025, even as structural adjustments became more…

Thursday, 27, November, 2025 / Published in China, IVDs, Medical Devices, News

China’s NMPA Releases Draft Adjustments to the IVD Classification Catalogue

China’s Center for Medical Device Standards Management under the National Medical Products Administration (NMPA) recently issued a public notice seeking…

Thursday, 23, October, 2025 / Published in IVDs, Malaysia, Medical Devices, News

Malaysia MDA Launches Public Consultation on Medical Device Labelling: Expanding e-Labelling and Accessibility Standards

On 16 October 2025, the Medical Device Authority (MDA) released the Draft 7th Edition of Guidance Document MDA/GD/0026 – Requirements…

Thursday, 23, October, 2025 / Published in China, IVDs, Medical Devices, News

UDI in China: Most Medical Devices Now Covered Under the Latest NMPA Drafts 

On 25 September 2025, the National Medical Products Administration (NMPA) released two draft announcements for public consultation: These drafts propose…