MDA Certificate of Free Sale and export certificates.

Registered device or export-only device.

MDA fees as published on MDA’s CFS and Export Certificate pages. They are set administratively, not in the Fifth Schedule, and were not changed by the 2026 fee amendment.

Certificate of Free Sale for registered devices

Since 1 October 2023, MDA issues a CFS only for registered medical devices. The applicant needs an establishment licence and proof of registration.

Documents

• Company registration certificate (SSM).
• Copy of the MDA establishment licence.
• Proof of registration: registration certificate, notification or acknowledgement letter.
• Device list on MDA’s template.

Fees and limits

• RM100 per registration number per country for 2 years, or RM300 for 5 years.
• One attachment of up to 25 devices included; RM5 for each extra page.
• Up to 25 registration numbers per application, all from one manufacturer.

Timeline

1. Invoice in BayarNow within 3 working days.
2. Complete applications processed within 14 working days.
3. Certificate emailed about 7 working days after payment clears.

If MDA asks for more information, reply within 14 working days or the application is treated as withdrawn. A device that is not yet registered needs MDA registration first.

Export-only devices: exemption letter, then Export Certificate

The Medical Device (Exemption) Order 2024 (P.U. (A) 78, in force 5 March 2024) exempts devices made solely for export (paragraph 3(1)(f)) and devices imported for re-export (paragraph 3(1)(g)) from registration, and exempts their importers and exporters from the establishment licence (paragraph 4). The exemption is not automatic: the manufacturer or exporter applies to MDA for it.

1. Export-only exemption letter. RM500 per device nomenclature, valid 5 years, no renewal (you reapply). Documents: company registration, application form, traceability or conformity attestation, the manufacturer’s ISO 13485 certificate (with a letter of authorisation from the certificate holder where needed), datasheet or IFU, and the establishment licence if you hold one.
2. Export Certificate. RM250 application fee plus RM100 (2 years) or RM300 (5 years) per country, RM5 per extra page. Documents: application form, the exemption letter, device list, the label for the importing country and an attestation. MDA’s example: one country, 100 devices, 2 years = RM365.

Export-only devices may not be sold or advertised in Malaysia. Certificates of Free Sale already issued for export-only devices under the old route stay valid until they expire.

Manufacturing Certificate

Manufacturers can apply for a Manufacturing Certificate through the same CFS system. An export-only manufacturer submits the same documents as for a CFS. An OEM manufacturer needs no establishment licence or registration, but submits an OEM declaration letter and a brochure.

Export permit under section 45

Act 737 section 45 also lets a licensed establishment apply for a permit to export a registered device (Form MDA1, regulation 15, RM100). MDA/GD/0024 states that neither the export permit nor a CFS is mandatory; they are needed when the importing country asks for proof that the device is sold in, or eligible for export from, Malaysia.

Using a Malaysian CFS abroad

A CFS is a supporting document, not a registration. The importing regulator still runs its own process. For the main export markets see CE marking under EU MDR, FDA 510(k), MDSAP and the Singapore HSA verification route.