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Latest News
Malaysia’s MDA publishes the 7th edition of guidance on medical device labelling, with new e-labelling, e-IFU, and accessibility requirements
Vietnam’s Drug Administration (DAV) is stepping up cosmetic product recalls as post-market surveillance tightens.
BPOM confirms pharmaceutical authorization, GMP oversight, and regulatory authority remain unchanged under the Indonesia–US trade agreement.
The 26 new medical device standards cover orthopedic implants, IVDs, active devices, and software risk management.
China’s NMPA has opened consultation on a draft mandatory toothpaste safety standard that could tighten product requirements.
China's HAF003 reform and participation in the "Tripling Nuclear Energy Declaration" signals stricter compliance and new opportunities.
Latest 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.
Latest Whitepapers
Learn about regulatory pathways, classification rules, testing requirements, and lifecycle compliance for IVD reagents.
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China Energy Label (CEL) requirements explained. Learn about product categories, energy efficiency testing, labeling rules, and approval procedures for China.
China NMPA drug registration explained. Learn about pharmaceutical approval pathways, regulatory framework, clinical trials, and market authorization for drugs in China.
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Learn how the China Manufacturer License (CML) applies to pressure vessels, boilers, and special equipment approvals.
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Latest Webinars
Watch the on-demand webinar with Hamish King and Victoria Caldy covering key China medical device regulatory updates from 2024, approval trends, the new draft law, GBA fast-track pathways, and compliance considerations for 2025.
Watch Cisema’s webinar on accessing China’s Greater Bay Area via Hong Kong listing. Learn about GBA pathway approvals, Hong Kong drug registration, and medical device market entry.
Join a free webinar on China’s MedTech market, regulations, and fast-track pathways during the UK’s International Trade Week 2025.
Join Cisema and HKSTP for a webinar on Hong Kong’s regulatory pathways and GBA market access for life and health tech ventures.
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