Medical Devices

From Sept 2025, Malaysia and Singapore launch a 6-month pilot to fast track medical device registration across ASEAN. Contact Cisema today.

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

Malaysia’s MDA will regulate aesthetic and cosmetic medical devices under the Medical Device (Designated Medical Devices) Order 2026.

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

Malaysia’s MDA and Thailand’s FDA launch a medical device reliance pilot to accelerate market access for Class B–D devices.

Malaysia clarifies that medical device tenders count as market placement, triggering licensing and compliance requirements.

Malaysia’s MDA withdraws personal use medical device importation Guidance Document, directing stakeholders to updated exemption requirements.

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

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

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

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

One of the primary objectives of China's centralized procurement mechanism is ensuring that the medicines and medical consumables...|One of the primary objectives of China's centralized procurement mechanism is ensuring that the medicines and medical consumables...