Insights from Across Asia-Pacific

Understand the key differences between China Medical Device GMP and ISO 13485, including requirements for quality management, suppliers, facilities and documentation.

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

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

Learn when medical device and IVD changes in Indonesia require a notification, variation, or new registration, and how to maintain ongoing regulatory compliance.

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.

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

Avoid common China infant formula labeling mistakes involving registration, allergen statements, date marking, milk-source claims, production changes, and existing inventory.

Track China’s 2026 imported health food approvals, monitor SAMR regulatory trends, and compare market activity by category and source with Cisema’s interactive tracker.

Gain clarity on often-misunderstood China Manufacture License (CML) requirements, including SELO approval, demo products, and CSEI audits.

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 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.

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

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

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

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

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

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

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

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