Blog Posts

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

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

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

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

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

This guide explains Singapore’s HSA regulatory system and why it is a strategic first step for entering Southeast Asian markets with medical devices, pharmaceuticals, and cosmetics.

From registration to tariffs and CPTPP benefits, here’s what Japanese cosmetics manufacturers need to know about Vietnam’s cosmetics market.

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

Learn how to prepare a compliant dossier for Vietnam medical device registration in this guide for foreign manufacturers.

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

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

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.

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

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

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

Learn how to fast-track medical device registration in ASEAN: timelines, costs, and license options in Malaysia, Singapore, and Vietnam.

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

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

Learn about China's Unique Device Identification (UDI) system and how to navigate China’s evolving medical device market.