Medical Devices

Guangdong’s MPA and Health Commission issued the 2025 GBA Connect “urgently needed” catalogue covering 115 Hong Kong–Macao drugs and devices.

Vietnam’s Ministry of Health moves to standardize and digitize medical device administration, improving transparency and compliance.

Indonesia’s BPS has updated KBLI business classification codes, impacting licensing, OSS data, and compliance for regulated sectors.

The draft 2026 catalogue defines which Class III medical devices would require clinical trial approval before trial initiation.

Learn about the 104 products China’s NMPA admitted into the Special Review Procedure for Innovative Medical Devices in 2025.

GB 4824-2025 aligns China’s EMC rules with CISPR 11:2024 and expands coverage to ISM equipment, robots, and medical electrical devices.

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.

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.

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