Regulatory News from Across Asia-Pacific

China issues technical guidance clarifying when post-filing updates to new cosmetic raw materials are permitted.

Taiwan issued regulations under the Regenerative Medicine Preparations Act, covering cell sourcing, recruitment, registration, and data retention.

China has issued the Fourth Batch of its Encouraged Generic Drugs Catalogue, opening new market opportunities for pharmaceutical companies.

China’s NMPA updated the Medical Device Classification Catalogue, revising requirements and classifications for 31 product categories.

Vietnam's Decree No. 26/2026/ND-CP” confirms MoH oversight of chemicals in medical devices, IVDs, and medicines.

Hong Kong’s Department of Health introduces Pre-NDA meetings to streamline new drug registrations under the “1+” mechanism.

Guangdong MPA expands GBA Connect Scheme to 71 hospitals, speeding urgent clinical access for Hong Kong and Macau-approved medical products.

The Department of Health has mandated MDACS listing for public procurement eligibility — see which devices are affected and how to prepare.

Indonesia’s Ministry of Health now enforces annual internal audits for medical device distributors under PP No. 28/2025.

Vietnam’s DAV intensifies inspections through March 2026, targeting cosmetic notification compliance and Product Information File readiness.

China’s H1 medical device imports reached approx. USD 24 billion, showing stable demand amid shifts in key categories and sourcing countries.

China signaled a shift in medical device procurement away from price focus, emphasizing clinical use and product quality.

China’s National Health Commission approved 14 new “Three New Foods,” covering novel food raw materials, food additives, and food-related products, with defined compliance conditions for use

China’s GACC Order No. 280 formalizes registration rules for overseas food manufacturers exporting to China.

China’s SAMR approved six imported health foods in 2025, ending a seven-year pause. Learn what this means for overseas brands.

Indonesia has expanded retail access for selected low-risk medical devices, opening new sales channels to benefit consumers.

China's multi-ministry pilot to classify imported food-medicine substances by use aims to simplify customs clearance for non-medicinal imports.

Indonesia’s Ministry of Health will temporarily close key medical device licensing and registration systems from December 2025 to January 2026

Vietnam’s Ministry of Health has delegated medical device oversight to specialized agencies, impacting registration and post-market surveillance.

China will launch a cosmetic e-label pilot on February 1, 2026. Explore the labeling requirements and what preparation is required.