Blog Posts

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

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

Get answers to common China medical device and IVD registration questions, from NMPA classification rules to testing and renewal requirements.

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

Learn about license validity and renewal rules for medical devices in Southeast Asia.

Learn how to register cosmetics in Malaysia under NPRA’s notification system aligned with the ASEAN Cosmetic Directive.

Cosmetic product registration and notification in Vietnam involves specific processes, fees, and timelines under the ASEAN Cosmetic Directive.

Explore the medical device market opportunities, regulations, and registration pathways across Malaysia, Singapore, Vietnam, and other key ASEAN countries.

Learn how MFDS’s Digital Medical Product Safety Management Roadmap will shape future compliance requirements for digital medical products in Korea.

Learn how to manage medical device renewals, variations, and change notifications in Vietnam with step-by-step MOH submission guidance.

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.

Learn how overseas cosmetic manufacturers can meet Indonesia’s BPOM notification requirements and legally bring their products to market.

Learn how South Korea medical device classification works under the MFDS.

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

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

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

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