Medical device exemptions in Malaysia: the Exemption Order 2024.

The exemption routes at a glance.

Paragraph 3(1) of the Order exempts these devices from registration under section 5 of Act 737. Paragraph 3(2)(a) requires anyone who imports, exports, manufactures or places a device on the market under routes (b) to (i) to apply to MDA for the exemption. Routes (a), (j), (k) and (l) are handled in the manner MDA sets.

Import for re-export (route (g)) is also exempt. MDA routes it to the same unit as export-only and personal use, but we have not found a separate published procedure for it. Charges are MDA’s administrative charges, paid through BayarNow; the guidance for each RM300 route says the charge is not refunded if the application fails.

What changed from the 2016 Order

• The 2016 Order (P.U. (A) 103/2016) had six exemptions. The 2024 Order has twelve: it adds export only, import for re-export, orphaned, obsolete and discontinued devices, and splits clinical research from performance evaluation.
• The 2016 Order asked importers and manufacturers to notify MDA in writing. The 2024 Order requires an application for exemption in the form MDA sets.
• The 2016 licence exemption covered people who import or manufacture exempted devices. The 2024 one covers people who import or export them, and excludes special access devices.
• Custom-made devices are now defined to exclude mass-produced devices that are adapted for a practitioner, and “personal use” now also bars use on a third party.
• Exemptions granted under the 2016 Order stay in force until amended or revoked (para 6(2)).

Special access: unregistered devices for patients

A special access device is one a medical practitioner needs in an emergency, or when conventional treatment has failed, is unavailable or is unsuitable. MDA/GD/0043 (Third Edition, March 2026) accepts four situations: an emergency that threatens a patient’s life or long-term wellbeing, compassionate use, a stock-out of a similar device (for example during a pending registration or change notification), and a device whose design is likely to improve the outcome of the procedure.

• Applicant: a local manufacturer or authorised representative holding an establishment licence. Without a licence the application is not eligible.
• Documents: the practitioner’s request letter with clinical justification and undertaking, ISO 13485 certificate, approvals in other countries, IFU or brochure, clinical evidence where relevant, the special access label and, where applicable, a letter of authorisation from the manufacturer.
• Scope: one application covers one healthcare facility and one group of devices, in the quantity for that supply only.
• Timing: RM300, reviewed within 7 working days of a complete submission; queries must be answered within 3 working days. The letter is valid for 6 months with no extension.
• Label: “Special Access Medical Device. For use only by a medical practitioner for patients under his/her care.”
• Afterwards: unused stock is disposed of, exported or registered, and a post-handling notice goes to MDA within 30 days of the letter expiring. To keep supplying, register the device under section 5.

Custom-made devices

A custom-made device is made to a healthcare professional’s written prescription for the sole use of one patient. Patient-matched, adaptable and mass-produced devices are not custom-made and must be registered (MDA/GD/0064). Typical examples are dental appliances, artificial eyes, hearing aid moulds, orthopaedic footwear and joint implants designed for one patient; see our dental device guide for crowns and aligners.

• The prescription names the patient, sets out the design characteristics specific to that patient and gives the planned surgery or fitting date where there is one.
• The manufacturer signs a statement for the custom-made device, and MDA’s page (updated 7 September 2026) says all manufacturers of custom-made devices must be certified to ISO 13485.
• Applications go through MeDC@St 2.0+: RM300, with an estimated 20 working days if the file is complete.
• Custom-made devices may not be advertised to the public (section 44 of Act 737). Records are kept for 5 years plus the device’s projected useful life.

Clinical research and performance evaluation

MDA/GD/0016 (April 2017) sets two routes, which MDA now takes in MeDC@St as Device Study and Clinical Research Use notifications:

• Clinical investigational use, a study that generates safety and performance data for registration. MDA’s technical committee reviews it (about 30 working days), then the ethics committee must approve the study before MDA issues the No Restriction Letter. The study must have a National Medical Research Registry (NMRR) ID.
• Clinical use or research-supportive use, such as an unregistered companion diagnostic in a drug trial. The notification goes to MDA without technical committee review.

In 2026 the committee meets monthly from January to November, with a submission deadline two to three weeks before each meeting and no December meeting. MDA/GD/0016 does not cover IVDs; ask MDA how an IVD performance evaluation should be filed before you ship samples.

Demonstration and education

Demonstration covers trade fairs, exhibitions and symposia. Education covers teaching and training with no marketing intent. In both cases the device must not be used on people. Under MDA/GD/0018, apply in MeDC@St at least 14 working days before import and pay RM300. A demonstration may last up to 90 days from the date of import, with one extension of up to 90 days at a different location. Devices are labelled “For Demonstration or Education Purpose Only. Not For Use On Human”, free samples are prohibited, and a post-handling notice is due within 30 days of the end of the demonstration. Advertising an unregistered device is a separate matter; see advertisement approval.

Export only and import for re-export

A device intended only for export does not need MDA registration, but the exporter applies for an Export Only Exemption Letter before shipping: RM500 per device nomenclature, valid 5 years, with no renewal. Where a buyer needs a certificate, MDA issues an Export Certificate for these devices, not a Certificate of Free Sale; fees and steps are on our Certificate of Free Sale guide.

Personal use

No application is needed, but MDA’s conditions (published 10 July 2026) apply. The buyer must be an individual buying in their own name for themselves or immediate family, not a company. The device must not be resold or used on a third party, its labelling must be kept, and no same or similar device may be registered in Malaysia. For professional-use devices, MDA may ask for a prescription or a recommendation letter. The guide quantity is one unit of each device type and three months’ supply of consumables. Personal-use imports are also exempt from the import permit.

Obsolete, discontinued and orphaned devices

These exemptions keep devices already in hospitals and clinics in service after their registration cannot be maintained. MDA/GD/0071 (First Edition, March 2026) covers obsolete and discontinued devices that were previously registered and are still in good working order. The manufacturer or AR applies with the manufacturer’s declaration, a declaration from each facility and a maintenance transition plan. The charge is RM300. MDA issues an invoice within 1–7 working days, which must be paid within 3 working days, and decides within 10 working days of a complete application with cleared payment. The Exemption Letter lasts 3 years and allows import and export only for maintenance and repair. The establishment keeps post-market duties for 5 years. Orphaned devices, whose manufacturer or AR has stopped operating, wait for a separate guidance document. Refurbishing or reselling used equipment is a different regime; see refurbished devices.

Class A: exempt from the CAB, not from registration

Paragraph 5 exempts Class A devices from conformity assessment by a CAB. They still need registration, filed directly with MDA; see our Class A registration guide. For Classes B to D, or once an exemption runs out, the route is full MDA registration.