Malaysia

Learn how Malaysia classifies drug–medical device combination products and how the PMOA determines pathways and compliance responsibilities.

Learn about Malaysia’s conformity assessment bodies — including CAB evaluation routes, risk classifications, and MDA registration steps.

Learn about license validity and renewal rules for medical devices in Southeast Asia.

Learn how to register cosmetics in Malaysia under NPRA’s notification system aligned with the ASEAN Cosmetic Directive.

Explore fast-track medical device registration in Southeast Asia, cut timelines by 6–12 months, and accelerate market entry with Cisema.

Learn how to fast-track medical device registration in ASEAN: timelines, costs, and license options in Malaysia, Singapore, and Vietnam.

Learn the Malaysia medical device registration process, covering MDA requirements, classification, CAB assessment, timelines, costs, and Authorised Representative roles.

Malaysia’s MDA publishes the 7th edition of guidance on medical device labelling, with new e-labelling, e-IFU, and accessibility requirements

Circular No. 1/2026 clarifies regulatory requirements for medical device procurement tenders, such as licensing and GDPMD compliance.

Malaysia’s NPRA introduces reliance and priority review pathways for additional indications of registered innovator drugs.

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

Malaysia’s NPRA mandates DEG and EG testing for high-risk oral liquid products , with mandatory compliance starting April 1, 2027.

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

Malaysia’s NPRA issues Directive No. 7 of 2026 mandating the Malaysian Guideline for GCP 5th Edition for clinical trials.

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

NPRA Circular No. 1/2026 updates Malaysia’s cosmetic ingredient annexes to align with the ASEAN Cosmetic Directive

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