KUALA LUMPUR, Oct 29 — The Malaysia-United States Agreement on Reciprocal Trade (ART) does not grant automatic market entry into Malaysia for medical devices manufactured in the US, said the Medical Device Authority (MDA).
The medical device regulator explained that under the bilateral agreement signed by Prime Minister Anwar Ibrahim and US president Donald Trump here last Sunday, Malaysia retained its authority to register American-made medical devices, ensuring that product safety, quality, and compliance with national requirements remained in place.
“Acceptance of US FDA (Food and Drug Administration) approvals does not mean automatic market entry, as all medical devices must still be registered with the MDA to ensure safety, quality, and compliance with local regulations,” said MDA in a statement.
CodeBlue reported yesterday the text of ART, which was published by the White House, that compels Malaysia to accept prior FDA approval or clearance as “sufficient evidence that a medical device manufactured in the United States meets Malaysia’s requirements for marketing authorisation”.
Malaysia also shall not require market authorisation for low-risk medical devices where marketing authorisation is not required by the FDA.
“A technical footnote in Article 2.4 clarifies that Malaysia may maintain its registration requirements while avoiding duplication of conformity assessments,” said MDA.
Malaysia’s medical device regulator noted that the 19 per cent US tariff rate on medical devices imported from Malaysia has been retained under ART, with tariff exemptions granted for three additional categories under the HS Codes 3006.30.10 (contrast media for diagnostic imaging), 3006.70.00 (medical lubricant), and 3808.94.10 (disinfectant for disinfecting medical devices).
“This measure supports both industry competitiveness and access to advanced health care technologies,” said MDA.
ART requires Malaysia to recognise audits and certificates of device manufacturers’ quality management systems that are in accordance with the requirements established by the Medical Device Single Audit Program (MDSAP) and conducted by auditing organisations authorised by the regulatory authorities participating in MDSAP to audit under the MDSAP requirements, “and shall not impose additional regulatory requirements beyond those required for MDSAP”.
Malaysia must also adopt relevant scientific or technical guidance documents developed through the International Medical Device Regulators Forum (IMDRF), when developing or implementing regulations for marketing authorisation of medical devices.
“Malaysia has accepted the requirements to become a member of IMDRF and MDSAP, in line with its commitment to global regulatory harmonisation,” said MDA.
“Malaysia has been a member of both initiatives since February 2025, reflecting the nation’s proactive approach toward international collaboration and regulatory excellence.”
MDA praised ART as an “important milestone in strengthening Malaysia’s position in the global medical device landscape.”
Besides the reduction of non-tariff barriers for medical devices, the trade deal compels Malaysia to accept FDA approvals and prior marketing authorisations for pharmaceuticals as “sufficient evidence” that such products meet Malaysia’s requirements for local marketing authorisation.
CodeBlue has requested comments from the National Pharmaceutical Regulatory Agency (NPRA) on the trade agreement.
