Insights from Across Asia-Pacific

Explore fast-track medical device registration in Southeast Asia, cut timelines by 6–12 months, and accelerate market entry with Cisema.

Learn the Malaysia medical device registration process, covering MDA requirements, classification, CAB assessment, timelines, costs, and Authorised Representative roles.

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

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

Learn about Malaysia’s conformity assessment bodies — including CAB evaluation routes, risk classifications, and MDA registration steps.

Learn how China medical device risk classification works under NMPA rules and see common compliance pitfalls to avoid.

Understand the key components of the Malaysia Medical Device Registration Dossier for Class B, C and D device submissions.

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

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

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

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

Learn how Indonesia halal cosmetic certification works, including BPJPH requirements, halal labeling rules, ingredient compliance, and registration obligations.

Understand Indonesia halal certification requirements for health supplements, including BPJPH registration, ingredient review, and halal labeling obligations.

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

Identify China medical device GMP gaps and prepare QMS, supplier, data, and inspection controls before NMPA market entry.

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

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.

Learn about Cisema’s redesigned website with faster performance, clearer navigation and expanded Asia Pacific coverage.