Custom-made medical devices: exempt from registration, not from MDA.

What the custom-made route is.

Paragraph 3(1)(h) of the Medical Device (Exemption) Order 2024 (P.U. (A) 78) exempts a custom-made medical device from registration under section 5 of Act 737. The exemption is conditional: paragraph 3(2)(a) requires anyone who imports, exports, manufactures or places a custom-made device in the market to apply to MDA first. MDA’s guidance is MDA/GD/0064(First Edition, 28 February 2023), and its custom-made page (updated 7 September 2026) sets the current process: an application in MeDC@St 2.0+, an RM300 charge, about 20 working days, and an ISO 13485 certificate for every custom-made manufacturer.

The route is narrow. A device that is patient-matched, adaptable or mass-produced is not custom-made, even if it is made for one person, and has to be registered.

The custom-made route at a glance

Custom-made, patient-matched, adaptable or mass-produced?

MDA/GD/0064 borrows the IMDRF definitions for personalised devices, and only one of the four categories can use the exemption:

Annex C of MDA/GD/0064 draws this as a decision tree. Read as questions, in order:

1. Is the device intended for a specific patient’s anatomo-physiological features or pathological condition? If not, it is not custom-made.
2. Is it mass-produced and then adapted, adjusted, assembled or shaped at the point of care? Then it is an adaptable device.
3. Is it made in batches by a process that can be validated and reproduced? Then it is patient-matched.
4. Was it made from the written request of an authorised healthcare professional? If yes, it is custom-made; if not, it is not.

MDA’s worked examples

Annex E of MDA/GD/0064 gives four cases:

• A mass-produced knee-ankle-foot orthosis (KAFO) that is assembled or adapted to the patient after supply is adaptable, so it is registered.
• A personalised acetabular cage and cup for an 81-year-old revision patient, which the implant maker designs within its specified design envelope using its existing production and verification methods, is patient-matched, so it is registered.
• An expandable distal femoral prosthesis whose characteristics the orthopaedic surgeon designs in a written request, outside the manufacturer’s own design characteristics, is custom-made.
• A 3D-printed distal tibial prosthesis made to an orthopaedist’s prescription from the patient’s CT images, specifying the dimensions, the medullary needle and the number, type and position of fixation screws, is custom-made.

The test is who sets the design and whether the process is validated, not whether the device fits one person. A 3D-printed implant can fall on either side.

Who prescribes, who makes, who applies

Annex D of MDA/GD/0064 lists the usual pairs of prescriber and maker, and the same device categories appear as tick-boxes on the application form:

• The prescriber. MDA/GD/0064 and MDA’s July 2026 form accept a medical practitioner, dental practitioner, pharmacist, clinical psychologist, nurse, midwife, medical assistant, physiotherapist, occupational therapist or another allied health professional listed in the Second Schedule of the Allied Health Professions Act 2016. The Exemption Order 2024 itself speaks of a prescription from a “qualified medical practitioner”. If your prescriber is not a doctor or dentist, confirm with MDA before relying on the prescription.
• The manufacturer is the legal person responsible for the design, manufacture, packaging and labelling of the device under its own name. It may be in Malaysia or abroad; the form asks a foreign manufacturer’s details to be entered with the state and city set to “Others”, and that section is left blank when the applicant is the local manufacturer.
• The applicant can be the establishment, the healthcare practitioner, a government department, or a government or private healthcare facility. Paragraph 3(2)(a) of the Order puts the duty to apply on whoever imports, exports, manufactures or places the device in the market, so agree in advance who files.

The written prescription

Clause 4.3 of MDA/GD/0064 says the prescription is issued by a healthcare professional and contains at least:

1. the name of the particular patient;
2. design characteristics specified by the professional that are unique to that patient’s anatomo-physiological features or pathological condition; and
3. the planned surgery date or device application date, where applicable.

Models (physical or 3D model data), moulds for dental or orthotic use and dental impressions that accompany the prescription also count as design characteristics. MDA’s page now offers an HCP template: a request addressed to MDA’s Chief Executive that gives the patient name and ID, the planned date, the device and a clinical justification. The professional confirms they accept responsibility for prescribing the device and acknowledges that it is not a registered medical device in Malaysia and that MDA does not assess or review its technical documentation in this process.

The manufacturer’s statement

Clause 4.4 of MDA/GD/0064 requires the manufacturer to draw up a statement of conformity for each custom-made device. It contains the data that identify the device (description, brand, model), the name of the patient it is for, the name of the requesting professional and their facility, the design characteristics that professional specified, and the manufacturer’s name and address. The Annex B template MDA now links adds:

• identifying features such as branding, material colour and size;
• anything packaged with the device;
• a table of the specified characteristics, for example “length: 15 mm”;
• the manufacturer’s certification that the device is safe and performs as intended; and
• a declaration that the manufacturer holds a valid ISO 13485 certificate, with its number, scope, date of issue and expiry date.

The statement is signed by the company’s responsible person and stamped.

ISO 13485 and the establishment licence

MDA’s custom-made page carries an important notice, last updated 7 September 2026, with two points:

• All manufacturers of custom-made medical devices are required to be certified to ISO 13485. The July 2026 requirement list asks for a copy of the manufacturer’s valid certificate with the device documents. MDA/GD/0064 (2023) did not mention ISO 13485; its only manufacturer duties were to meet the custom-made criteria, classify the device under the First Schedule of the Medical Device Regulations 2012, and ensure it is safe and performs as intended. If your lab or workshop is not certified, see our ISO 13485 service.
• The establishment licence exemption applies only to a person who imports or exports the exempted device. That is paragraph 4 of the Order. An importer bringing in a custom-made device made overseas is exempt from the licence for it; a Malaysian manufacturer that makes and supplies custom-made devices is not covered by the exemption. See establishment licence.

Applying in MeDC@St

MDA/GD/0064 describes an emailed form and payment by bank draft. MDA has moved the route online: applications are submitted through MeDC@St 2.0+. MDA warns that the custom-made module runs on an earlier version of MeDC@St 2.0 and may show system bugs, which it says will not affect submission. An applicant without an account signs up at MeDC@St and chooses Notification as the reason for the account.

What the form asks for

1. Applicant details: role, name, NRIC or passport, designation and organisation.
2. Prescriber details: name, annual practising certificate number (NA if not applicable), contact details and healthcare facility.
3. Manufacturer details, unless the applicant is the local manufacturer.
4. The custom-made statement with the patient-specific design characteristics (models, moulds or impressions) and the written prescription naming the patient and the planned date.
5. The patient’s reference number (MRN or hospital information system ID).
6. The attestation and declaration.
7. Device details (Annex A): name, grouping, description and intended use (each up to 255 characters), brand, model, the manufacturer’s name and address exactly as on the label, the class and classification rule, and any marketing approval in other countries. MDA notes that these details are printed on the letter.
8. Uploads: instructions for use, product brochure, product label, the manufacturer’s statement (Annex B) and the manufacturer’s ISO 13485 certificate.

In the declaration the signatory confirms the product is a medical device under section 2 of Act 737, meets the custom-made definition and complies with MDA/GD/0064, and accepts responsibility for post-market surveillance and vigilance. A false declaration is an offence under section 76 of Act 737.

Timeline

If MDA asks for more information, MDA/GD/0064 gives the applicant 30 working days to provide it; after that the application may be cancelled and a new one is needed. The guidance calls MDA’s approval a “No restriction letter / Certificate of Exemption for Custom made medical device”, which permits the applicant to import or place the device in the Malaysian market. Neither MDA/GD/0064 nor MDA’s page states a validity period for it, and MDA can revoke it if the conditions are breached.

Labelling

Paragraph 7(1) of the Sixth Schedule to the Medical Device Regulations 2012, repeated in clause 4.5 of MDA/GD/0064, requires the labelling of a custom-made device to include:

• identification as a custom-made device, with a statement that it is only used by a qualified practitioner for a patient under their care (para 7(1)(a)); and
• an indication that it is for use by a single individual and was manufactured according to a written prescription or pattern (para 7(1)(o)).

The rest of the labelling rules are on our labelling page.

Duties once the device is supplied

Clause 6 of MDA/GD/0064 makes the applicant responsible for these conditions:

• Notify MDA of the import or placement of the device.
• The exemption covers only the device and site listed in the application, and only the declared purpose.
• The applicant is responsible for the import and placement, including supply chain activities, and keeps the device traceable through the supply chain.
• No advertisement to the general public.
• Post-market surveillance and vigilance under Chapter 3 of Act 737 and the Medical Device (Duties and Obligations of Establishments) Regulations 2019; see mandatory problem reporting and post-market surveillance.
• Records, including the application documents, kept for 5 years on top of the projected useful life set by the manufacturer. MDA’s example: a one-year useful life means six years of records.
• Comply with MDA’s directions and allow inspection at any time without prior notice.

If these conditions are not met, MDA can revoke the exemption letter. Supplying an unregistered device without a valid exemption is an offence under section 5 of Act 737: a fine of up to RM200,000, up to three years’ imprisonment, or both.

Common situations

• Dental laboratories. Crowns, bridges and dentures made to a dentist’s prescription and impression are MDA’s first example of custom-made devices. MDA’s announcement of 11 November 2024 clarified that dental products, including crowns and aligners, are medical devices, that local laboratories making them must register them, and that products meeting the custom-made criteria may instead apply for the exemption. Details are on our dental device page.
• Clear aligners. Aligners produced from a scan through a validated digital workflow within a design envelope fit the patient-matched definition and are registered.
• Implants made overseas for one patient. The hospital or the importer applies, with the surgeon’s prescription and the foreign manufacturer’s statement and ISO 13485 certificate. The importer is exempt from the establishment licence for that device under paragraph 4 of the Order.
• Orthoses and prostheses. A prescribed, individually designed limb prosthesis or orthopaedic shoe can be custom-made. A stock orthosis fitted or adjusted at the clinic is adaptable and is registered, like MDA’s KAFO example.
• Hearing aids. Hearing aid inserts and moulds, and in-the-ear aids, made to an audiologist’s or audiology technician’s specification are on MDA’s list of examples. A standard behind-the-ear aid supplied from stock is mass-produced and is registered.

What has changed since MDA/GD/0064 was published

• The Order. MDA/GD/0064 was written under the Medical Device (Exemption) Order 2016, which the 2024 Order (gazetted 5 March 2024) revoked. The 2024 definition expressly excludes mass-produced devices adapted to a practitioner’s or other professional user’s requirements, and paragraph 3(2)(a) calls the process an application for exemption.
• Submission. From an emailed form with a bank draft or BayarNow payment to MeDC@St 2.0+.
• Timeline. MDA/GD/0064 gave 14 days on a complete application; MDA’s current process flow gives 14 working days for the evaluation inside an estimated 20 working days in total.
• ISO 13485. Now required of every custom-made manufacturer, with the certificate uploaded and declared in the statement (July and September 2026).
• HCP template. A standard prescription and request letter, with the professional’s acknowledgement that MDA does not review the technical documentation.

One inconsistency to be aware of: the declaration in Annex A of MDA/GD/0064 warns of a fine of up to RM500,000 or three years’ imprisonment under section 76, while section 76(1) of the Act on MDA’s portal sets up to RM100,000 or two years, or both.

Our reading

• Decide the category before you file. A product from a validated, reproducible digital workflow is usually patient-matched, not custom-made. If the manufacturer’s process sets the design, plan for registration.
• The file is built around one patient. The prescription, the statement and the form all name a patient and a prescriber. It is not a product approval you reuse for the next order.
• Get ISO 13485 in place first. Since 2026 the certificate is part of the application, so a workshop without one does not meet MDA’s requirements for the route.
• Keep the records for the device’s life plus five years. For an implant with a long projected life, that is a long time; build it into your document control.

Other exemption routes, including special access for unregistered devices a doctor needs now, are compared in our Exemption Order 2024 guide.