MDA special access: an unregistered device for patients who need it now.

What special access is.

A special access medical device is a device for the use of medical practitioners in emergency situations, or when conventional medical treatment has failed, is unavailable or is unsuitable. Paragraph 3(1)(i) of the Medical Device (Exemption) Order 2024 (P.U. (A) 78) exempts it from registration under section 5 of Act 737, but only after an application to MDA. The procedure is MDA/GD/0043, Third Edition, March 2026: the application goes through MeDC@St, costs RM300, is reviewed within 7 working days of a complete submission, and the exemption letter lasts 6 months with no extension.

Special access at a glance

The four situations MDA accepts

A device qualifies only if it falls under one of the situations in Table 1 of MDA/GD/0043. MDA’s special access page warns that applications which do not meet these criteria, or lack proper justification, will be rejected.

The applicant must also be sure the product is a medical device at all. If in doubt, MDA points to MDA/GD/0006 on the definition of a medical device and to its product classification application; see our classification guide.

Who applies, and who asks for the device

Special access has two parties, and neither can file without the other.

• The applicant is the person responsible from a local manufacturer or an authorised representative. Paragraph 4 of the Order exempts importers and exporters of other exempted devices from the establishment licence, but it excludes special access devices, and the MeDC@St form says an applicant without an establishment licence is not eligible. MDA’s special access page (updated 11 May 2026) goes further: applicants must hold a valid licence “specifically as an Authorized Representative and Importer”. A local manufacturer relying on a manufacturer licence alone should confirm with MDA before filing.
• The medical practitioner requests the device or takes responsibility for it at the declared premises. The form records the practitioner’s name, title (hospital director, head of department, specialist or physician, or medical officer), annual practising certificate number and the healthcare facility where the device will be used.

In practice a hospital that needs an unregistered device asks the manufacturer’s licensed AR, or another licensed AR the manufacturer authorises, to apply; the letter of authorisation from the legal manufacturer is one of the supporting documents where applicable.

Documents for the MeDC@St application

1. Manufacturer’s ISO 13485 QMS certificate
2. Pre-market approval or registration certificate from other countries
3. Instructions for use, operations manual or product brochure from the manufacturer
4. Clinical evidence of the device’s safety and effectiveness for the intended use, if relevant
5. The special access label
6. Establishment licence (AR or manufacturer)
7. Letter of authorisation from the legal manufacturer, if applicable
8. The practitioner’s request letter with the clinical justification and statement of undertaking, on the healthcare facility’s letterhead (template in Annex C)

What the medical rationale section asks

Section D of the form is where most applications are won or lost. It asks for:

• the qualifying situation, ticked from the four above;
• the diagnosis or condition, the treatment or procedure, why the device should be exempted and why an alternative treatment is not used;
• the registration status: the registration issue, the MeDC@St submission ID (draft or under evaluation), the CAB assessment status, and any previous registration number and validity;
• the MDA-registered devices that were considered and why they would not meet the patient’s needs;
• the risks and benefits, and how the benefits outweigh the risks;
• a summary of the known safety and effectiveness information;
• where conventional treatment has failed or is unsuitable, the patient’s condition;
• in an emergency, the number of devices needed to treat the patient for one month; and
• the quantity for batch release, if batch release is required.

Quantity and scope

One application covers one group of devices (a system, family or set is listed device by device with its identifier and quantity) for one healthcare facility. The quantity is only what will be supplied to that facility under that application; MDA/GD/0043 states that the quantities are not for future supply. A second hospital, or a later need, means a new application.

Step by step

If MDA rejects the application, or it lapses for want of a reply, the RM300 is not refunded, but a fresh application may be made. A device that does not meet the criteria has to be registered; see MDA registration.

The special access label

Paragraph 7(1)(a) of the Sixth Schedule to the Medical Device Regulations 2012 requires a special access device to be identified as such, with a statement that it is used only by a qualified practitioner for patients under their care. MDA/GD/0043 gives the wording:

“Special Access Medical Device. For use only by a medical practitioner for patients under his/her care.”

The label is uploaded with the application. The rest of the labelling rules are on our labelling page.

Duties while the letter is in force

Clause 8 of MDA/GD/0043 makes the exemption conditional on the applicant’s duties:

• No import or supply before the exemption letter is issued.
• The device is used only for the purpose in the letter and is not repurposed.
• Every device carries the special access labelling.
• The applicant provides the IFU and user manuals and, where applicable, on-site training for practitioners, users and technical staff.
• Active devices that need installation are installed, tested, commissioned and accepted by personnel trained, appointed or certified by the manufacturer, with warranty, technical support and spare parts available to the facility.
• After an adverse incident the applicant takes immediate corrective action and handles post-market issues under the Medical Device (Duties and Obligations of Establishments) Regulations 2019. The applicant is a licensed establishment, and section 40 of Act 737 sets the incident-reporting deadlines for establishments; see mandatory problem reporting.
• Records of every action, including what happened to the devices after expiry, are kept at the applicant’s premises for MDA to review.
• To keep supplying after the six months, the device is registered under section 5 of Act 737.

The practitioner’s undertaking adds the user side: the device is used only for the stated purpose, it is used safely and appropriately or under supervision in line with section 43 of Act 737, and adverse events are reported to MDA immediately.

A breach of the letter’s terms may lead MDA to revoke the exemption and may amount to a breach of section 5 of Act 737, which carries a fine of up to RM200,000, up to three years’ imprisonment, or both.

When the six months end

Devices that have not been installed, placed in the market or registered by the end of the validity period are dealt with in one of three ways:

1. disposal of the device;
2. export out of Malaysia; or
3. registration with MDA.

The applicant emails a post-handling notice on the Annex D form, which MDA asks to be returned to sa.cm@mda.gov.my, no later than 30 days after the validity period ends. The form lists each device, the quantity imported and the quantity handled by each method, and the signatory declares that the unregistered devices have been disposed of, destroyed or exported. Keep the disposal records, export documents and any registration certificates as proof.

Special access compared with research and demonstration

Custom-made, export-only and obsolete-device exemptions are covered in our Exemption Order 2024 guide. A patient buying a home-use device for themselves does not need special access; see personal-use imports.

What changed in the Third Edition

The Second Edition (May 2020) was written under the 2016 Exemption Order and a COVID-19 emergency. The Third Edition (March 2026) made these changes:

• It cites the Exemption Order 2024 and calls the process an exemption application; the 2020 edition used a notification and a “No restriction letter”.
• Route A (emergencies) and Route B (the other situations) were removed; all four situations now follow one process.
• Submission moved from an emailed form to MeDC@St.
• Payment moved from a bank draft to BayarNow. The 2020 edition waived the charge for donations; the Third Edition mentions no waiver.
• A 6-month validity period was added, with no extension.
• Record-keeping for post-expiry handling was added, along with the Annex C request letter template.

Searches for a “special access route” or “special access programme” often return Singapore, Canada or Australia, which run their own schemes. In Malaysia the route is paragraph 3(1)(i) of the Exemption Order 2024 and MDA/GD/0043.