Blog Posts

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

Learn all about HSA medical device registration in Singapore with timelines, fees, and AR requirements in this step-by-step guide.

Explore Vietnam’s fast-track and standard medical device registration pathways and the role of reference approvals in shortening timelines.

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

Discover how leveraging Real World Data generated in the Greater Bay Area can accelerate market entry for medical products in China.

Learn how the medical device markets of Thailand, Indonesia, and the Philippines differ in terms of regulation, healthcare growth, and commercial opportunity.

Gain an overview of the medical device registration process in Vietnam with timelines, fees, and Authorized Representative requirements.

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.

Navigate cosmetic product registration in Singapore in this guide offering key insights and practical tips.

Learn how a smart clinical trial strategy for medical devices in China can speed up NMPA approval and bring your product to market faster.

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 5 key steps for China dental medical device registration, covering classification, biocompatibility testing, and legal agent selection.

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.