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Malaysia medical device registration resources

Research MDA registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Malaysia medical device resource.

49,700 registration records11 free resources24/25 requirements covered12 regulations trackedAug 2026 fees reviewed
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Medical device registration database

Search official MDA device registration records.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official MDA regulations and guidance documents.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Government registration fees

Review current MDA application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely MDA pathway, government fees, dossier preparation time, review timeline, and registration steps.

Medical device regulation news

Follow recent MDA policy, guidance, and compliance updates.

AI medical device classifier

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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Malaysia requirements.

AI similar registered product finder

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Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Structured regulatory requirements

Explore all 63 source-linked facts →

24 of 25 research dimensions currently covered · 29 official sources · latest verification 2026-09-07

Market entry

D01

Authority & regime

Verified
Competent authority
Medical Device Authority (MDA, Pihak Berkuasa Peranti Perubatan), established under the Medical Device Authority Act 2012 [Act 738], is the competent authority implementing the Medical Devi…
Minister of Health role
The Minister of Health makes regulations and orders under section 79(2) of Act 737, designates devices by order, and determines appeals against Authority decisions; the Minister's appeal de…
2 source-linked facts
Checked 2026-08-25
Open details →
D02

Legal basis & guidance

Verified
Current binding instruments
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 Obligati…
Medical Device Regulations 2012 commencement
The Medical Device Regulations 2012 came into operation on 1 July 2013.
3 source-linked facts
Checked 2026-08-25
Open details →
D03

Device definition & scope

Verified
Medical device definition
Medical device (peranti perubatan) covers any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or similar article intended b…
Borderline products by Ministerial declaration
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 'prescr…
2 source-linked facts
Checked 2026-08-25
Open details →
D04

Classification rules

Verified
Risk classes A through D.
Class A, Class B, Class C, Class D
1 maintained scheme · 1 related fact
Checked 2026-08-25
Open details →
D05

Registration pathways

Verified
Registration requirement
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…
Two-stage registration process
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 Conform…
4 source-linked facts
Checked 2026-08-25
Open details →
D06

Reliance & recognition

Verified
Recognised foreign approvals for the verification route
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 (spe…
Approvals excluded from the verification route
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, Hea…
11 source-linked facts
Checked 2026-08-25
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D07

Economic-operator roles

Verified
Establishment roles
Establishment (establismen) means (a) a manufacturer, importer or distributor responsible for placing a medical device on the market (retailer excluded), and (b) an authorised representativ…
Authorised representative appointment and duties
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 manu…
2 source-linked facts
Checked 2026-08-26
Open details →
D08

Establishment, import & distribution

Verified
Establishment licence requirement
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, i…
Establishment licence validity
An establishment licence is recorded in the Register for three years from the date of issue unless cancelled earlier.
5 source-linked facts
Checked 2026-08-25
Open details →
D09

Dossier requirements

Verified
Dossier format and language
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 Malaysi…
Conformity evidence elements
Conformity assessment for registration comprises four elements: (a) quality management system, (b) post market surveillance system, (c) technical documentation, and (d) declaration of confo…
3 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
MeDC@St online system
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 (includ…
Prescribed forms
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 regula…
2 source-linked facts
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Labelling and IFU language
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 info…
Statutory labelling content and endorsement ban
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 cle…
3 source-linked facts
Checked 2026-08-25
Open details →
D12

QMS, audit & inspection

Verified
QMS assessment depth by class
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…
Acceptable QMS certificates
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 16…
3 source-linked facts
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
MDA electrical/EMC evidence
Electrical safety
MCMC/SIRIM communications product certification
Wireless / radio
JAKIM medical-device halal certification
Halal / materials
5 maintained overlays
Checked 2026-09-07
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D14

Fees

Verified
Registration application fee - Class A
MYR 500
Registration application fee - Class B
MYR 250
22 maintained fee lines · 1 related fact
Checked 2026-08-25
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D15

Review clocks

Verified
Class A · Registration
14-20 working days
Class B · Registration
30 working days
Class C · Registration
30 working days
4 maintained pathways · 1 related fact
Checked 2026-08-30
Open details →
D16

Approval validity & renewal

Verified
Registration validity
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…
Re-registration window and lapse
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 do…
3 source-linked facts
Checked 2026-08-26
Open details →

Lifecycle & post-market

D17

Change control

Verified
Change notification categories
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 p…
New-registration change triggers
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 classific…
3 source-linked facts
Checked 2026-08-26
Open details →
D18

UDI, listing & traceability

Verified
UDI implementation status
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); surv…
Public register and traceability duties
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 eac…
2 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical research and performance evaluation route
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…
1 source-linked fact
Checked 2026-08-25
Open details →
D20

Special access & derogation

Verified
Registration exemption categories
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; clinica…
Special access exemption conditions
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 situatio…
2 source-linked facts
Checked 2026-08-25
Open details →
D21

Manufacturer PMS

Verified
Post-market surveillance duties
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…
1 source-linked fact
Checked 2026-08-25
Open details →
D22

Vigilance & incident reporting

Verified
Mandatory problem reporting deadlines
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 inad…
Investigation report deadline
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…
2 source-linked facts
Checked 2026-08-25
Open details →
D23

Recall, FSCA & market surveillance

Verified
Recall notification timeframes by class
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 consequenc…
Recall final report
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…
2 source-linked facts
Checked 2026-08-25
Open details →
D24

Advertising, claims & promotion

Verified
Advertisement pre-approval requirement
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 adv…
Advertisement application and content
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 t…
2 source-linked facts
Checked 2026-08-25
Open details →
D25

Submission communications & appeal

Verified
Deficiency response process
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…
Appeal route and deadline
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…
2 source-linked facts
Checked 2026-08-25
Open details →

Government fees

Full fee schedule (22 lines) →

MDA registration fees in MYR · reviewed 2026-08-25

Fee lineAmountProvenance
Registration application fee - Class AMYR 500Verified
Registration application fee - Class BMYR 250Verified
Registration application fee - Class CMYR 500Verified
Registration application fee - Class DMYR 750Verified
18 more fee lines on the full schedule · 22 of 22 rows source-verified

Registration timeline

Full registration timeline →

Medical Device Authority (MDA) review clocks and planning ranges · 4-class (A, B, C, D) classification

Class / pathwayReview clockPlanning totalProvenance
Class A(Registration)14-20 working days1-3 monthsVerified
Class B(Registration)30 working days3-6 monthsVerified
Class C(Registration)30 working days3-6 monthsVerified
Class D(Full Registration)30 working days3-6 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(14-20 working days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All Malaysia regulation news →

Newest official MDA headlines from the daily-refreshed feed — every row links directly to the authority publication.

Aug 19MDMedical Device AuthorityTraining 12: Fundamentals of Software as a Medical Device (SaMD)MalaysiaAug 19MDMedical Device AuthorityTraining 14: Mastering risk classification and grouping of IVDsMalaysiaAug 11MDMedical Device AuthorityMedical Device Act 2012 (English)MalaysiaAug 6MDMedical Device AuthorityPress Release: Implementation of the Hologram Security Label for Medical DevicesMalaysiaOct 06, 25MDMedical Device AuthorityGuideline on How to apply for establishment License under medical device act 2012 (Act 737)Malaysia

Key regulations

All 12 Malaysia regulations →

Official MDA rules and guidance · 12 of 12 documents linked to official sources

Act 737Medical Device Act 2012 - Full Legal Text
GeneralVerified
P.U. (A) 500Medical Device Regulations 2012
GeneralVerified
Legislation CollectionMDA Legislation Documents Collection
GeneralVerified
MDA PortalMedical Device Authority Official Portal
GeneralVerified

Registry insights

Full registry statistics →

Computed from 49,700 official MDA registration records · data as of 2026-08-25

49,700
Registrations
2,462
Authorized Representatives
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Build a reusable product master

Structure company, product, model, approval, certificate, and evidence facts before starting Malaysia work.

Malaysia market-launch workpaper

Connect the MDA route, evidence, labels, local role, timing, and dependencies to a wider launch plan.

Malaysia dossier reuse and delta

Compare an existing authorization and evidence set against MDA administrative, testing, labeling, and dossier needs.

Malaysia change notification workpaper

Map a product or manufacturing change to MDA evidence, notification, timing, and implementation questions.

Malaysia regulatory change impact

Assess a current MDA update against one product and turn it into an owner-ready action workpaper.

Malaysia cybersecurity evidence review

Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Malaysia (MDA).

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