Thursday, 19, March, 2026 / Published in Blog, China, Medical Devices

Entering China’s Intraocular Lens (IOL) Market: NMPA Registration Requirements for Foreign Manufacturers

Intraocular lens (IOL) registration in China is the gatekeeper to market access, determines whether global ophthalmic innovation can successfully translate…

Friday, 13, March, 2026 / Published in Blog, China, Medical Devices

Accelerating NMPA Approval: Building the Right China Medical Device Clinical Trial Strategy from Day 1

A well-designed China medical devices clinical trial strategy often determines whether a product reaches the Chinese market in 12 months…

Tuesday, 10, March, 2026 / Published in Blog, China, Medical Devices

China Dental Medical Device Registration: 5 Key Considerations For Entering The Dental MedTech Market

China’s dental MedTech market is one of the fastest-growing globally, with strong demand across dental implants, imaging systems, high-performance equipment,…

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

China Medical Device and IVD Registration FAQs: What Foreign Manufacturers Need to Know About NMPA Requirements

While China’s regulatory framework is well defined, many overseas companies still encounter uncertainty around classification rules, Chinese technical standards, Product…

Thursday, 12, February, 2026 / Published in Blog, China, IVDs, Medical Devices

China IVD Risk Classification Explained: How NMPA Class Shapes Registration Pathways

China IVD risk classification is the first and most consequential regulatory decision foreign manufacturers face when bringing an in vitro…

Thursday, 12, February, 2026 / Published in Blog, China, Medical Devices

China Medical Device Risk Classifications: How NMPA Device Class Determines Registration Pathways

China medical device risk classifications are the starting point for every regulatory decision a manufacturer makes when entering the China…

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…

Tuesday, 3, February, 2026 / Published in Blog, Malaysia, Medical Devices, Medical Devices, Medical Devices, Singapore, Vietnam

Medical Device Market Access in ASEAN: Malaysia, Singapore, and Vietnam Compared

Medical device market access in ASEAN has become a strategic priority for international manufacturers seeking sustainable growth in Southeast Asia.…

Friday, 16, January, 2026 / Published in Blog, China, GBA Connect, Hong Kong, Medical Devices, Pharma & Biotech

GBA Connect Scheme: Using Real World Data to Support China NMPA Approval

Real World Data (RWD) collected through the GBA Connect Scheme can be transformed into standard clinical evidence for the National…