Medical Devices

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.

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

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

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.

NMPA issues draft changes to China’s IVD Classification Catalogue, adding new risk classes and technology platforms.

Indonesia revises medical device and IVD registration timelines under Permenkes 11/2025, extending approval timelines.

The new GMP for medical devices, effective Nov 1 2026, introduces stricter quality, personnel, and supplier controls.

Malaysia’s MDA introduces a two-year validity for Product Classification Letters from May 1, 2025 – see timelines and requirements.

Rising Class III medical device registrations in China during Q1–Q3 2025 signal opportunities for foreign manufacturers of advanced devices.

Malaysia’s MDA has increased Class A medical device registration fees effective January 2026 — impacting all new and renewal submissions.