The Medical Device Authority (MDA) of Malaysia has announced the successful conclusion of the Malaysia–United States Agreement on Reciprocal Trade, marking a landmark achievement for the nation’s medical device industry. The announcement coincides with the ASEAN Summit 2025, underscoring Malaysia’s commitment to advancing international trade and regulatory cooperation in the healthcare sector.
Scope
Summary of the press – release by the Medical Device Authority (MDA) concerning the Malaysia–United States Agreement on Reciprocal Trade, which strengthens bilateral collaboration in the medical device sector and reinforces regulatory alignment with global standards.
Key Highlights
Regulatory Authority & Oversight
- Malaysia retains regulatory authority to register U.S.-manufactured medical devices, ensuring that all products continue to meet national safety, quality, and compliance standards.
Recognition of U.S. FDA Approvals
- While U.S. FDA approvals are recognised as part of the verification process, they do not confer automatic market access.
- All medical devices must still undergo registration with the MDA prior to being marketed in Malaysia.
Tariff Updates
The existing 19% tariff rate on medical devices remains in effect, with exemptions introduced for three additional categories under HS Codes
- 3006.30.10
- 3006.70.00
- 3808.94.10.
International Regulatory Cooperation
- Malaysia reaffirms its commitment to global regulatory harmonisation by joining the International Medical Device Regulators Forum (IMDRF) and the Medical Device Single Audit Program (MDSAP).
- Membership took effect in February 2025, enhancing Malaysia’s alignment with international regulatory frameworks.
Read the official press release issued by the Medical Device Authority (MDA) of Malaysia: [PDF linked here]
Effective Date
To be announced upon implementation of the Agreement.
Implications to Stakeholders
This agreement represents a pivotal step in streamlining trade and enhancing Malaysia’s competitiveness in the global medical device market. Manufacturers and distributors should monitor forthcoming implementation updates and prepare for continued compliance with MDA registration procedures, even for devices already approved by the U.S. FDA.
For inquiries or support regarding medical device registration under the new trade framework, please contact sales@andamanmed.com or reach out to us.
