Medical Devices

Understand MFDS clinical trial requirements for digital medical devices, including real-world evidence, data-based studies, and software validation expectations.

Supporting foreign manufacturers entering South Korea with regulatory services for medical devices, IVDs, and quasi-drugs.

Learn which products are covered by Indonesia's halal framework, the labeling and manufacturing obligations, and phased compliance timelines.

Cisema offers regulatory insight and market access strategy for medical devices in Thailand, Indonesia, and the Philippines.

Learn how to register medical devices in Indonesia, including Authorized Representative rules, classification, dossiers, timelines, and fees.

Understand the pathway for intraocular lens (IOL) registration in China, including NMPA requirements and key compliance steps.

China’s 15th Five-Year Plan signals stronger support for innovative drugs, advanced medical devices, reimbursement reform, and NMPA regulatory pathways.

Enter Southeast Asia’s dental market with a clear strategy: navigate regulatory complexity, sequence market entry, and retain control of registrations to scale efficiently.

A complete guide to China hyaluronic acid registration, covering classification, NMPA requirements, and compliance steps for manufacturers.

Track all imported Class II and III medical device approvals in China with this monthly updated NMPA submission tracker.

Learn how Malaysia classifies drug–medical device combination products and how the PMOA determines pathways and compliance responsibilities.

Practical China medical device glossary explaining NMPA terms, with clear comparisons to US FDA and EU MDR terminology.