Explore the medical device requirements currently available for Malaysia, organized by topic and linked to official sources.
What expires, what is retained periodically, and when must renewal start?
A registered medical device is kept in the Register for five years from the date of registration unless the registration is cancelled earlier; fees are on a per-application basis for the 5-year validity period.
The re-registration function in MeDC@St 2.0+ opens exactly one year before the current registration certificate expires; the system automatically deactivates certificates upon expiry and does not allow any re-registration submission after expiry (including unsubmitted drafts), after which a new registration application subject to the full conformity assessment process is required.
On cancellation of a registration the Authority notifies the registration holder in writing, who may submit a written show cause within ninety days from receipt of the notification.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Changes to registered devices fall into three categories: Category 1 - changes affecting safety and performance requiring new registration (e.g. new intended purpose, risk-class change, non-permissible variants); Category 2 - changes requiring MDA evaluation and endorsement prior to implementation; Category 3 - changes implementable immediately upon submission of complete documents through MeDC@St. A category-confirmation request may be made to MDA beforehand.
Category 1 triggers for a new registration application include: change to intended purpose (except indication reductions not driven by safety/performance concerns), change of risk classification, addition of devices beyond permissible grouping variants, certain IVD cluster variant additions, and addition of devices under different proprietary names.
MDA/GD/0072 'Change Management for Registered Medical Devices' (first edition, 2026) is published and will replace MDA/GD/0020, but is not yet implemented; it takes effect only upon the official launch of MedCAST 3.0, and until then MDA/GD/0020 remains applicable and in force.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Establishment (establismen) means (a) a manufacturer, importer or distributor responsible for placing a medical device on the market (retailer excluded), and (b) an authorised representative appointed by a manufacturer with its principal place of business outside Malaysia.
A manufacturer not located in Malaysia must appoint an authorised representative (AR) to act on its behalf; for imported devices the AR obtains all conformity evidence from the foreign manufacturer and is responsible for appointing an MDA-registered CAB to conduct the conformity assessment.
Which label and IFU elements, languages, symbols, and translation controls apply?
Bahasa Malaysia is required for home-use medical devices; English shall be used on labelling for other device types, and other languages may be used as necessary; where Bahasa Malaysia information is provided it shall appear on the label itself.
Confirms and refines the baseline labelling-language fact with the current 7th edition (22 May 2026).
Labels must not state or imply that marketing or use of the device is encouraged or endorsed by the Authority or Ministry of Health (fine up to RM10,000 and/or 3 months); labels must be clear, indelible and legible; the Sixth Schedule requires device identification (name, model, lot/serial, manufacture and expiry dates), manufacturer details and, for foreign-made devices, the authorised representative's name, address and contact number.
Electronic IFU (e-IFU) is eligible for devices intended for professional users; for home-use devices it depends on a documented risk analysis; users must always be able to obtain a paper copy on request at no additional cost, the web address must be printed on the physical label, and e-label content must be identical to the approved printed IFU.
Which current law, regulation, guidance, and transition provisions apply?
Framework: Medical Device Act 2012 (Act 737); Medical Device Regulations 2012 (P.U.(A) 500); Medical Device (Advertising) Regulations 2019 (P.U.(A) 317); Medical Device (Duties and Obligations of Establishments) Regulations 2019 (P.U.(A) 318); Medical Device (Exemption) Order 2024 (P.U.(A) 78); Medical Device (Amendment) Regulations 2025 (P.U.(A) 330); Medical Device (Designated Medical Device) Order 2026 (P.U.(A) 10).
MDA's official legislation inventory; each instrument was opened individually where cited elsewhere in this file.
The Medical Device Regulations 2012 came into operation on 1 July 2013.
The Medical Device (Advertising) Regulations 2019 came into operation on 1 July 2020.
Gazette PDF is scanned; text recovered by OCR from the official file.
Is the product a device, IVD, accessory, software, or borderline product locally?
Medical device (peranti perubatan) covers any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or similar article intended by the manufacturer for human use for diagnosis, prevention, monitoring, treatment or alleviation of disease, injury compensation, anatomical/physiological support, life support, contraception, device disinfection, or in vitro examination of specimens, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means. Software and IVD reagents/calibrators are expressly included.
The Minister may, by gazette order and taking into account public safety, health or risk issues, declare any article used on the human body to be a medical device, and may determine 'prescribed/designated medical devices' subject to a separate permit regime.
What local class follows from which rules and decisive product facts?
If an establishment disputes a CAB's classification, it may apply in writing to the Authority within 30 days of the dispute, and the Authority must notify its decision within 30 days of the application.
Which registration, notification, listing, reliance, or conformity route applies?
No medical device may be imported, exported or placed on the Malaysian market unless it is registered under Act 737; contravention is punishable with a fine up to RM200,000, imprisonment up to 3 years, or both.
Registration is two-stage: (Stage 1) conformity assessment by an MDA-registered Conformity Assessment Body (CAB) covering QMS, PMS system, technical documentation and Declaration of Conformity; (Stage 2) application to MDA via MeDC@St with the CAB report and certificate. Registration requires completion of the CAB conformity assessment procedure.
Confirms baseline market-access route with the Act provision; operational detail in MDA/GD/0070.
Class A medical devices are exempt from the CAB conformity assessment procedure; new and re-registration applications for Class A are submitted directly to MDA via MeDC@St.
From 1 June 2026, specified medical lasers used for aesthetic purposes (alexandrite 756nm, diode 800nm, Er:YAG, fractional CO2, Nd:YAG, pulse-dye, ruby) are designated medical devices; no person may use or operate a designated device without a designated medical device permit under Act 737 (fine up to RM100,000 and/or 1 year imprisonment).
Which foreign decisions or evidence can be reused, with what effect and conditions?
Devices holding at least one qualifying approval from MDA-recognised authorities may use CAB conformity assessment by way of verification instead of full assessment: EU Notified Bodies (specified MDR/IVDR and legacy directive certificates), Japan MHLW (Ninsho/Shonin), Australia TGA (ARTG), Health Canada (licence), US FDA (510(k)/PMA), UK MHRA (UKCA for GB; EC/UKNI certificates for Northern Ireland), Singapore HSA (SMDR registration), Thailand FDA (Class 2-3 notified / Class 4 licensed device certificates).
Replaces the list formerly in MDA Circular Letter No. 1/2025 Annex 1; Second Edition (13 October 2025) added HSA and Thai FDA.
Special-access-type authorisations are not eligible for the verification route, including US FDA EUA / Expanded Access / HDE, EU exceptional use authorisations, UK MHRA exceptional use, Health Canada SAP / Interim Orders, Japan compassionate use and emergency regulatory pathway, TGA SAS / Authorised Prescriber / emergency exemptions, HSA Special Access Routes, and Thai FDA section 27 non-commercial exemptions.
Pilot Phase 1 (30 July - 30 September 2025) under the MDA-NMPA MoU: Chinese-made IVDs (Class II approved by Provincial MPA or Class III by NMPA, manufacturer owning its China facility) are eligible for Malaysia's verification pathway, and Malaysian-made IVDs (Class B, C or D approved by MDA) are eligible for China's green channel; up to 6 applications per side, priority for rare-disease and innovative devices.
ARTG Registration Certificate from Australia TGA qualifies a Class B/C/D device for CAB conformity assessment by way of verification.
Specified EC certificates issued by EU Notified Bodies (MDR Annex IX Ch. I & III / Annex XI Part A; IVDR Annex IX Ch. I & III / Annex X + XI; and legacy 93/42/EEC, 90/385/EEC, 98/79/EC certificates) qualify for the verification route, mapped to the corresponding Malaysian class.
Health Canada Licence qualifies for the verification route.
Pre-market certification (Ninsho) from a Japanese registered certification body or pre-market approval (Shonin) from MHLW qualifies for the verification route.
Registration in the Singapore Medical Device Register (SMDR) qualifies for the verification route.
Thai FDA Class 2-3 Certificate of Notified Medical Device or Class 4 Certificate of Licensed Medical Device qualifies for the verification route.
For Great Britain: UKCA marking; for Northern Ireland: EC certificates (and UKNI together with EC certificates) from recognised EU NB approval types qualify for the verification route.
US FDA 510(k) clearance or Premarket Approval (PMA) qualifies for the verification route.
Which establishment licences, importer permissions, and distribution controls apply?
No establishment may import, export or place on the market any registered medical device unless it holds an establishment licence; contravention is punishable with a fine up to RM200,000, imprisonment up to 3 years, or both.
An establishment licence is recorded in the Register for three years from the date of issue unless cancelled earlier.
An application for renewal of an establishment licence shall be made to the Authority not later than one year before its expiry, and additional information requested must be provided within 30 days; on renewal the licence is again recorded for three years.
From 1 July 2024 MDA implements the 'one licence for each establishment role' policy: new establishment licence applications are limited to one role (manufacturer, importer, distributor or authorised representative) per application, and at renewal multi-role licence holders must keep one role in the renewed licence and separate the others via new licence applications.
MDA processes complete establishment licence applications within 14-21 working days.
Which evidence, local deltas, formats, and signatures are required?
Evidence of conformity is compiled per the Common Submission Dossier Template (CSDT) prescribed in Appendix 2 of the Third Schedule of MDR 2012; the CSDT shall be prepared in Bahasa Malaysia or English, and English and/or Bahasa Malaysia are the only acceptable languages for submissions and correspondence.
Conformity assessment for registration comprises four elements: (a) quality management system, (b) post-market surveillance system, (c) technical documentation, and (d) declaration of conformity; the CAB issues an assessment report and certificate that must be submitted with the registration application.
The registration dossier requires a Declaration of Conformity in the Appendix 3 (Third Schedule) format on manufacturer letterhead signed by top management; a QMS certificate (ISO 13485 or other acceptable QMS); for active devices electrical safety/EMC evidence (IEC 60601-1 series); and a post-market surveillance summary covering reportable adverse events and field corrective actions for the past 3 years; for re-registration, an updated DoC, updated PMS and a declaration of no change over the last 5 years if applicable.
Which current form, portal, account, and submission package must be used?
MeDC@St (Medical Device Centralised Online Application System, current version MeDC@St 2.0+) is the fully web-based portal through which all establishment licence and medical device (including IVD) registration applications, re-registrations and change notifications are submitted; one account per applicant suffices for all application types.
Registration and establishment licence applications are made in forms determined by the Authority (submitted through MeDC@St); an export permit application is made in Form MDA1 under regulation 15(2) of MDR 2012.
Which QMS, audit, inspection, and certificate scope is accepted or required?
The Third Schedule prescribes class-graded CAB scrutiny of the manufacturer QMS: Class A devices - CAB verification limited to sterility maintenance and/or metrology compliance; Class B - full QMS with CAB review and field audit where deemed necessary; Class C and D - full QMS with CAB review and field audit; the manufacturer, AR for a foreign manufacturer, importer and distributor must each operate a QMS appropriate to their role.
Confirms the baseline QMS fact with the regulation text.
For registration, updated ISO 13485 certificates are required from the legal manufacturer, or other acceptable QMS evidence: MDSAP, US FDA Quality System Regulation, Japan MHLW Ordinance 169, or ISO 9001 (only for a Class A empty gas cylinder).
MDA was recognised as an MDSAP Affiliate Member effective 16 September 2025 and accepts MDSAP audit reports and certificates as QMS evidence: local manufacturers for establishment licence applications (audit performed by an MDA-registered CAB with an MDA-registered MDSAP-qualified auditor) and foreign manufacturers for device registration (reports issued by any MDSAP-recognised Auditing Organisation).
What regulator fee applies to this class, route, event, and date?
If requested information is not provided within the stipulated time the registration application is rejected and the application fee is not refundable, without prejudice to the right to make a new application.
What review, validation, and applicant stop-clock rules apply?
Regulation 5(3) MDR 2012 requires additional requested information or samples within 90 days of request; under Act 737 s. 6(5) failure to provide requested information within the specified period (or granted extension) causes the application to be deemed withdrawn, without prejudice to a new application; operationally MDA/GD/0070 applies 30 working days for mandatory information (refusal ground if missed) and 90 working days for other additional information (rejection if missed).
Which UDI, device listing, database, and traceability duties apply?
UDI is not yet mandatory in Malaysia. MDA ran a UDI readiness pilot survey in two phases (Class D establishments 7 June - 31 July 2024; Class B establishments 15 August - 15 October 2024); survey results will determine the implementation timeline and updates in MeDC@St 3.0+. UDI means a numeric/alphanumeric code of Device Identifier (DI) plus Production Identifier (PI).
The medical device Register (MDAR) is available for public access (searches/copies on request against the Fifth Schedule fee); every establishment must maintain distribution records for each device manufactured, imported, exported or placed on the market and provide them to the Authority on request.
Which clinical or IVD performance evidence or study is required and accepted?
Unregistered devices imported for clinical research or performance evaluation are exempt from registration under section 5, subject to an exemption application/notification to the Authority: a Device Study (DS) notification (with Clinical Investigational Plan per ISO 14155, Clinical Performance Study Protocol and Investigational Brochure) or a Clinical Research Use (CRU) notification, submitted through the MeDCAst system.
Notification mechanics and ISO 14155 documents per MDA Clinical Research Study page (updated 24 December 2025).
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
Under the Medical Device (Exemption) Order 2024 (made under section 77 of Act 737), devices are exempted from registration for: personal use; demonstration for marketing; education; clinical research; performance evaluation; export only; import for re-export; custom-made devices; special access devices; orphaned, obsolete and discontinued devices. Categories (b)-(i) require an exemption application to the Authority; importers/exporters of exempted categories (except special access) are also exempt from the establishment licence requirement.
A special access medical device is one for use by medical practitioners in emergency situations or where conventional treatment has failed, is unavailable or unsuitable; qualifying situations include emergencies, compassionate use, stockout alleviation and enhanced procedure outcomes. The applicant is the local manufacturer or the Authorised Representative; the exemption is valid for 6 months; after expiry/termination the devices must be disposed of, exported, or proceed to registration, with records kept as proof; a healthcare professional request letter is required (Annex C template).
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
Every establishment must monitor the safety and performance of devices it manufactures, imports, exports or places on the market, operate a post-market surveillance system as prescribed by the Minister, and properly record and evaluate adverse-incident surveillance reports; it must also maintain documented complaint-handling procedures and records. The Medical Device (Duties and Obligations of Establishments) Regulations 2019 detail these duties (distribution records, complaint records, mandatory problem reporting, field corrective action, voluntary and mandatory recall), fully enforced from 1 July 2022.
2019 Regulations scope and enforcement date per official MDA announcement (portal.mda.gov.my pengumuman/634).
What is reportable, by whom, where, in what format, and by what deadline?
Establishments must report to the Authority incidents occurring in or outside Malaysia: within 30 days of awareness for device failure, deterioration in effectiveness, or labelling/IFU inadequacy; within 10 days where the incident led to (or could lead to) death or serious deterioration of health; within 48 hours for serious public health threats. Contravention: fine up to RM200,000 and/or 2 years imprisonment. If reportability is uncertain the report must still be submitted within the timeframe, and incomplete information must not delay reporting.
Operational timelines mirrored in MDA/GD/0014 cl. 3.4.1.
After completing the investigation of a reported incident, the establishment must submit the investigation report and form to the Authority within 30 days after submission of the Mandatory Problem Report; extensions of 90, 120 or 150 days after MPR submission may be granted on request.
Which recall, FSCA, notice, and authority-coordination duties apply?
The establishment must notify the Authority and all affected persons on or before initiating a recall, within the class-based timeframe: Class I recall (high risk, serious health consequences or death probable) - within 48 hours; Class II (medium risk) - within 3 working days; Class III (low risk) - within 5 working days. Statutorily, section 42(2) Act 737 requires information to be given to the Authority on or before conducting a recall, and the Authority may order a recall at any time for patient safety or public health.
The establishment shall submit a recall report to the Authority within 30 days after completion of the recall, covering the circumstances leading to the recall and consequent actions; under section 42(3) Act 737 the outcome and preventive actions must be reported as soon as possible after completion.
Which claims, audiences, channels, approvals, and restrictions apply?
No person may advertise any registered medical device without approval from the Authority (fine up to RM200,000 and/or 2 years imprisonment); separately, section 44(1) Act 737 prohibits advertising any device that is not registered (fine up to RM300,000 and/or 3 years) and section 44(2) prohibits misleading or false claims.
Applications for advertisement approval are made in writing with a copy of the proposed advertisement and a processing fee of one thousand ringgit (RM1,000), plus an appointment letter if the applicant is appointed by the registration holder; the advertisement must contain a statement that the device is registered under the Act and the MDA registration number.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
Query responses during evaluation are submitted in MeDC@St with a written response to each input-request query, referencing uploaded file names (Class A: Section 10 'Any related information'; Class B/C/D: CSDT-Misc section); the Authority may refuse registration on grounds including non-provision of mandatory information within 30 working days, inaccurate classification, non-medical-device status, or revoked establishment licence.
A person aggrieved by an Authority decision under sections 7, 9, 12, 14, 18, 22, 24, 30, 33, 35, 45 or 46 of Act 737 may appeal to the Minister: a copy of the notice of appeal must be sent to the Minister by registered post within thirty days of the decision, stating the appellant's particulars, the decision, the grounds and supporting documents, accompanied by the appeal fee (RM250 per Fifth Schedule); the Authority submits its reasons within 30 days, and the Minister may confirm, reverse or vary the decision, which is final and binding.
