MDA · structured requirements

🇲🇾 Malaysia IVD regulatory data

Explore the IVD requirements currently available for Malaysia, organized by topic and linked to official sources.

14 facts7 dimensions9 official sourceslatest verification 2026-10-21

Changes after registration

Common questions about changing a registered IVD in Malaysia. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Source-linked rules available
How do I update a manufacturer's name without changing the legal entity? →Source-linked rules available
What changes when the manufacturer's office address changes? →Source-linked rules available
Does a catalogue or reference code change affect registration or UDI? →Source-linked rules available
Can a registration transfer to a different legal entity? →Source-linked rules available
Can several changes be filed together? →Source-linked rules available

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

Compare countries

Transfer of the registration between ARs

answers.ar-holder-transfer

Fact-level verified

GD0041 provides a registration-ownership application by the new AR after registration and after pending applications are completed or withdrawn. The effective transfer date is MDA approval, not the manufacturer appointment-letter date. Its current/new AR forms and unchanged manufacturer field do not establish unrestricted substitution of a different foreign legal manufacturer.

Conditions

Distinguish a real new AR/registration-holder legal person from a same-entity rename and from a new foreign manufacturer.

Logo and other label edits

answers.artwork-other-labels

Fact-level verified

A logo or layout edit must be checked against GD0020 5.6.3. Other label-information changes can be Category 3; the listed no-CN exceptions cover rephrasing/reordering IFU information, adding/removing languages not required by MDA, and distributor information that does not affect registered information. A new device name or registered identifier is assessed separately under the Category 2 row; a logo edit is not automatically exempt.

Combining changes and pending applications

answers.cn-bundles-and-sequence

Fact-level verified

The official FAQ permits any Category 2/3 changes for one medical device in one CN. Combining2-50 devices requires similar changes and is limited to the listed types, including specified facility/QMS/manufacturer-name or administrative-address changes. A pending CN for the same device must finish before another CN can be submitted. List every related change in Annex B; this permission does not combine an ownership transfer automatically.

MDA/GD/0020 Change Notification for Registered Medical Device, Fourth Edition (21 November 2022)

Manufacturer name and administrative office changes

answers.manufacturer-office-cat3

Fact-level verified

GD0020 Table 2 5.6.4(c) assigns manufacturer registered-name or administrative-office-address changes, and manufacturing-site-name-only changes with no site-address change, to Category 3. These changes may be implemented after complete documents are submitted. A physical manufacturing-site move has a different Category 2 branch; it is not assumed for an office-only change.

Name and registered identifier changes

answers.name-identifier-cat2

Fact-level verified

A change to a registered device name or identifier with no change to intended use or technical specifications is Category 2 under GD0020 Table 1 5.5.6(d). A proprietary-name change caused by acquisition or merger is also listed there. Obtain MDA evaluation and endorsement before implementation and market placement. An additional device under another proprietary name may instead trigger new registration under 5.3(f).

Conditions

The common registered-device rules expressly include IVDs; IVD-specific technical changes retain their separate categories.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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AR transfer documents, fee and timing

answers.ar-transfer-materials-fee-clock

Fact-level verified

GD0041 requires Annex A signed by the new AR, its establishment licence, manufacturer LOA under GD0027 and a manufacturer request naming the devices and appointment date before submission. The current AR supplies Annex B, surrenders certificates and transfers distribution/complaints records. The guide gives approximately 30 working days from complete submission and RM 500 per registration ID; original certificate validity continues from its initial registration date.

Conditions

The guide describes registration-holder/AR transfer; it is not a complete foreign-manufacturer succession dossier.
Approximate timing is not a guarantee.

Documents for manufacturer name or office CN

answers.manufacturer-office-documents

Fact-level verified

The Category 3 manufacturer-information row calls for a declaration of conformity, the manufacturer undertaking to support devices already supplied under its former name where applicable, amended labels, an updated QMS certificate or relevant official evidence of the change, and annexes. The undertaking is post-market support evidence; it does not grant an unrestricted old-label sell-through period.

Evidence for a name or identifier CN

answers.name-identifier-documents

Fact-level verified

The Category 2 name/identifier row requires a declaration of conformity, a manufacturer declaration that the device is unchanged including intended use and technical specifications, updated configurations identifying affected devices, labels showing every amended section and annexes. The summary must state present/proposed information and reasons for all related changes.

Fees

What regulator fee applies to this class, route, event, and date?

Compare countries

Change-notification fees by category and ID

answers.cn-specific-fees

Fact-level verified

The official CN fee table charges Category 2 RM 50/500/1000/1500 for Classes A/B/C/D respectively, or RM 2500 for a device containing a medicinal product; Category 3 is RM 30 across the merged class column. For a single ID with both categories, add the category fees; for multiple IDs multiply each applicable category fee by its ID count. The printed three-Class B-ID Category 2+3 example totals RM 1590.

Conditions

These are CN fees, separate from new-registration, CAB, ownership-transfer or export-certificate charges.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

Compare countries

Labels must stay aligned with the registered device

answers.labels-and-ivd-details

Fact-level verified

GD0026 Seventh Edition requires device name/model and manufacturer information, plus the applicable local manufacturer/AR contact and IVD particulars. Labelling compliance may be completed after import or manufacture but before market placement; added AR/importer/translation labels must preserve the specified original traceability/date information. Changes to electronic labels follow GD0020, and corresponding paper IFUs must remain aligned.

Conditions

Bahasa Malaysia is required for home-use devices; English applies to other devices.
Relabelling permission is not a blanket old-stock grace or permission to market changed Category 2 devices before endorsement.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Malaysia approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Malaysia (9 records)

MalaysiaUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: Accepted as reference-country evidence supporting the conformity assessment, but the MDA publishes no shorter period for it
Timeline Savings: None published

MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround ACCSQ Medical Device Product Working Group — Implementing the ASEAN Medical Device Directive: "Not intended to confer mutual recognition; each member state retains sovereign right for registration decisions"

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MalaysiaNMPA

Prior approval / evidence record

Malaysia-China Phase 2 joint evaluation: excludes already registered devices

reliance.china-nmpa-bilateral-programme

Fact-level verified

Statement: Following the 2025 IVD reliance pilot (Phase 1, held), MDA and NMPA launched Pilot Phase 2, the Malaysia-China Joint Evaluation Pilot Programme, from 1 July to 30 September 2026 under the GHWP Common Evaluation Reliance Practice (CERP) framework. Phase 2 replaces one-way reliance with simultaneous, collaborative assessment by both regulators of devices not yet registered in either country: Chinese manufacturers submit to NMPA under its Special Channel Pilot Programme and Malaysian manufacturers submit to MDA for full conformity assessment, with each authority evaluating and issuing its own certificate. This is not a pathway for a product that already holds a China NMPA registration certificate.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: No prior registration certificate in either China or Malaysia (eligibility prerequisite)
Target Jurisdiction Id: malaysia
China Classes In Scope: China-made NMPA Class II or III general medical devices and IVDs (via NMPA 'Special Channel Pilot Programme'); Malaysian-made Class B/C/D GMD and IVDs (via MDA full conformity assessment)
Edge Type: Bilateral Programme
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Pilot window 1 July - 30 September 2026
Manufacturer must be based in, and own and operate, the manufacturing facility in China (for China-made) or Malaysia (for Malaysian-made)
Device must not already hold a registration certificate in Malaysia or China
Not open to third-party brand owners (rebranders, relabelers, contract assemblers)
Malaysian route: establishment licence, premarket screening by MDA, CAB full conformity assessment per MDA/GD/0031, MeDC@St submission, 5-year MDAR listing
China-made route: submission to NMPA (contact info@ChinaMedDevice.com per announcement)

Effective from 2026-07-01 · Effective until 2026-09-30

Source passage: The second phase introduces a Joint Evaluation approach. Unlike the previous reliance model, this phase enables collaborative, simultaneous assessment by both the MDA and NMPA. ... Device Classes: Class B, C, or D (GMD or IVD) [Malaysian-Made] / Class II or Class III (GMD or IVD) [China-Made]. Prior Registration Status: The device must not have obtained registration certificates in Malaysia or China.

MalaysiaASEAN

Prior approval / evidence record

ASEAN Medical Device Directive (AMDD) harmonisation

Name: ASEAN Medical Device Directive (AMDD) harmonisation
Description: The AMDD gives the ten member states one device definition, one set of classification rules, one set of essential principles and one dossier structure, the Common Submission Dossier Template. It is not a reliance route. The ACCSQ Medical Device Product Working Group states in terms that the Directive is "not intended to confer mutual recognition" and that each member state retains the sovereign right to make its own registration decisions, so a registration in one ASEAN market authorises nothing in another and shortens no national review period.
Timeline Reduction: None — the saving is in dossier preparation, since one CSDT core can be reused across member states with national addenda
Eligibility: Any device filed in an ASEAN member state that has transposed the AMDD into national law

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MalaysiaASEAN

Prior approval / evidence record

ASEAN member-state registration

Authority: ASEAN member-state registration
Accepted: No
Benefit: There is no ASEAN mutual recognition agreement for device registration — the AMDD harmonises the dossier, not the decision
Timeline Savings: None

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MalaysiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Singapore HSA · TFDA (jurisdiction not specified in this entry)

Prior approval / evidence record

Class B

class-b

Class Name

Class B

Risk Level

medium

Pathway

Registration

Official Timeline

Min: 30
Max: 30
Unit: working-days

Verification Status

official-verified

Official Source

Title: MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
Url: https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
Accessed Date: 2026-08-25

Realistic Timeline

Min: 3
Max: 6
Unit: months

With Prior Approval

Min: 3
Max: 6
Unit: months

Prior Approval Benefits

EU CE Mark
MHLW
TGA
Health Canada
FDA
MHRA
HSA
TFDA

Notes

MDA/GD/0070 cl. 6.4: Class B registration turn-around 30 working days from complete documents and cleared payment
ASEAN harmonization applies

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MalaysiaNMPA

Regulatory reference

China NMPA approval: not reference

reliance.china-nmpa-not-reference

Fact-level verified

Statement: Outside the time-limited bilateral pilots, MDA's verification route (abbreviated CAB conformity assessment) is available only for devices holding a qualifying approval from the authorities enumerated in MDA/GD/0070 Annex 1 Table 5: EU Notified Bodies, Japan MHLW, Australia TGA, Health Canada, US FDA, UK MHRA, Singapore HSA and Thai FDA. China's NMPA is not in the table, so an NMPA-only device must undergo full conformity assessment.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: malaysia
China Classes In Scope: Class B/C/D devices and IVDs under the standard conformity-assessment-by-verification route; NMPA approvals not eligible
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Recognised authorities per Table 5: EU NB, Japan MHLW (Ninsho/Shonin), Australia TGA (ARTG), Health Canada licence, US FDA 510(k)/PMA, UK MHRA (UKCA / EC-UKNI), Singapore HSA (SMDR), Thai FDA (Class 2-3 notified / Class 4 licensed)
Apply the current verification eligibility and exclusions in MDA/GD/0070. The September 2025 revision removed the one-year prior marketing requirement; do not reintroduce it.
This conclusion is limited to the ordinary verification pathway, not every possible bilateral programme.

Effective from 2025-10-13

Source passage: Types of approvals eligible for conformity assessment by way of verification process

MalaysiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Singapore HSA · TFDA (jurisdiction not specified in this entry)

Prior approval / evidence record

Class C

class-c

Class Name

Class C

Risk Level

high

Pathway

Registration

Official Timeline

Min: 30
Max: 30
Unit: working-days

Verification Status

official-verified

Official Source

Title: MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
Url: https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
Accessed Date: 2026-08-25

Realistic Timeline

Min: 3
Max: 6
Unit: months

With Prior Approval

Min: 3
Max: 6
Unit: months

Prior Approval Benefits

EU CE Mark
MHLW
TGA
Health Canada
FDA
MHRA
HSA
TFDA

Notes

MDA/GD/0070 cl. 6.4: Class C registration turn-around 30 working days from complete documents and cleared payment
Clinical data may be required

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MalaysiaUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · UK MHRA · Singapore HSA · TFDA (jurisdiction not specified in this entry)

Prior approval / evidence record

Class D

class-d

Class Name

Class D

Risk Level

highest

Pathway

Full Registration

Official Timeline

Min: 30
Max: 30
Unit: working-days

Verification Status

official-verified

Official Source

Title: MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
Url: https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
Accessed Date: 2026-08-25

Realistic Timeline

Min: 3
Max: 6
Unit: months

With Prior Approval

Min: 3
Max: 6
Unit: months

Prior Approval Benefits

EU CE Mark
MHLW
TGA
Health Canada
FDA
MHRA
HSA
TFDA

Notes

MDA/GD/0070 cl. 6.4: Class D registration turn-around 30 working days from complete documents and cleared payment
Clinical evidence required

Clinical Trial Required

Yes

Local Testing Required

Gmp Required

Yes

MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

MalaysiaEU conformity assessment

Prior approval / evidence record

EU CE Mark

Authority: EU CE Mark
Accepted: Yes
Benefit: Accepted as reference-country evidence supporting the conformity assessment, but the MDA publishes no shorter period for it
Timeline Savings: None published

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

CN review targets and implementation points

answers.cn-specific-times

Fact-level verified

GD0020 Table 5 lists30 working days for a single submission ID in Category 2 or3,60 working days for a single ID combining2+3, and60 working days for multiple IDs. These targets start with a complete application and supporting documents. Category 2 still requires endorsement before implementation; Category 3 may be implemented on complete submission rather than waiting for that administrative target.

Source provenance & time

Which original source, locator, and effective period support each fact, and when was it last verified?

Compare countries

GD0020 remains the conditional current basis

answers.current-transition-and-renewal

Fact-level verified

MDA announcement1799 makes GD0072 implementation conditional on the formal launch of MeDC@St3.0. The 14 October2026 re-registration guide still describes3.0 as under development, with a December2026 target and a further announcement before implementation. Use GD0020 for the recorded current CN answer unless a formal launch changes that condition. The automated2.0+ renewal route requires no active/pending CN or COO for the device.

Conditions

A development target or visible3.0 login page is not the formal implementation event.
Recheck a later launch announcement before an actual filing.

MDA Automated Re-Registration Route guide, Revision2,14 October2026

Related structured datasets

Classification systems · 1 record

Open Risk classes A through D. →

malaysia:medical-device

Jurisdiction Id

malaysia

Domains

medical-device
ivd

Name

Risk classes A through D.

Classes

Id
a
Label
Class A
Normalized Risk Level
low
Id
b
Label
Class B
Normalized Risk Level
medium
Id
c
Label
Class C
Normalized Risk Level
high
Id
d
Label
Class D
Normalized Risk Level
highest

Regulator

MDA

Official Domains

mda.gov.my

Source Status

official-source-verified

Source Title

Medical Devices Regulations 2012 — First Schedule (Rules of Classification of Medical Device, paras 3-4, Appendices 1-2)

Source Url

https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf

Verified On

2026-08-25

Source Supports

class-axis
classification-rules
ivd-class-axis
ivd-classification-rules

Notes

First Schedule para 3(1): the manufacturer is responsible for classification; para 3(2): four classes A-D by risk to patients, users and other persons.
Appendix 1 general-device rules (non-invasive, invasive, active, special): highest class applies when multiple rules match; software driving a device takes the device's class; standalone software may be a device; accessories classified separately. Appendix 2 IVD rules: Class D for blood/transfusion screening agents and congenital-disorder screening; Class C for self-testing.
Act 737 s. 3(1): classification done by the establishment based on risk level, intended use and vulnerability of the human body; disputes with a conformity assessment body go to the Authority (decision within 30 days per reg. 3(3) MDR 2012).

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Malaysia registration →

Country

Malaysia

Jurisdiction Id

malaysia

Country Code

Flag

🇲🇾

Regulator

Medical Device Authority

Regulator Abbrev

MDA

Region

asia-pacific

Tier

Risk Classification

4-class (A, B, C, D)

Classes

Id
class-a
Class Name
Class A
Risk Level
low
Pathway
Registration
Official Timeline
Min
14
Max
20
Unit
working-days
Verification Status
official-verified
Official Source
Title
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
Url
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
Accessed Date
2026-08-25
Realistic Timeline
Min
1
Max
3
Unit
months
Notes
MDA/GD/0070 cl. 6.4: Class A registration turn-around 14-20 working days from submission of complete documents and cleared payment
Simplified registration
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
class-b
Class Name
Class B
Risk Level
medium
Pathway
Registration
Official Timeline
Min
30
Max
30
Unit
working-days
Verification Status
official-verified
Official Source
Title
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
Url
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
Accessed Date
2026-08-25
Realistic Timeline
Min
3
Max
6
Unit
months
With Prior Approval
Min
3
Max
6
Unit
months
Prior Approval Benefits
EU CE Mark
MHLW
TGA
Health Canada
FDA
MHRA
HSA
TFDA
Notes
MDA/GD/0070 cl. 6.4: Class B registration turn-around 30 working days from complete documents and cleared payment
ASEAN harmonization applies
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
class-c
Class Name
Class C
Risk Level
high
Pathway
Registration
Official Timeline
Min
30
Max
30
Unit
working-days
Verification Status
official-verified
Official Source
Title
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
Url
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
Accessed Date
2026-08-25
Realistic Timeline
Min
3
Max
6
Unit
months
With Prior Approval
Min
3
Max
6
Unit
months
Prior Approval Benefits
EU CE Mark
MHLW
TGA
Health Canada
FDA
MHRA
HSA
TFDA
Notes
MDA/GD/0070 cl. 6.4: Class C registration turn-around 30 working days from complete documents and cleared payment
Clinical data may be required
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
class-d
Class Name
Class D
Risk Level
highest
Pathway
Full Registration
Official Timeline
Min
30
Max
30
Unit
working-days
Verification Status
official-verified
Official Source
Title
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
Url
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
Accessed Date
2026-08-25
Realistic Timeline
Min
3
Max
6
Unit
months
With Prior Approval
Min
3
Max
6
Unit
months
Prior Approval Benefits
EU CE Mark
MHLW
TGA
Health Canada
FDA
MHRA
HSA
TFDA
Notes
MDA/GD/0070 cl. 6.4: Class D registration turn-around 30 working days from complete documents and cleared payment
Clinical evidence required
Clinical Trial Required
Yes
Local Testing Required
No
Gmp Required
Yes

Expedited Pathways

Name
ASEAN Medical Device Directive (AMDD) harmonisation
Description
The AMDD gives the ten member states one device definition, one set of classification rules, one set of essential principles and one dossier structure, the Common Submission Dossier Template. It is not a reliance route. The ACCSQ Medical Device Product Working Group states in terms that the Directive is "not intended to confer mutual recognition" and that each member state retains the sovereign right to make its own registration decisions, so a registration in one ASEAN market authorises nothing in another and shortens no national review period.
Timeline Reduction
None — the saving is in dossier preparation, since one CSDT core can be reused across member states with national addenda
Eligibility
Any device filed in an ASEAN member state that has transposed the AMDD into national law

Prior Approvals

Authority
FDA 510(k)
Accepted
Yes
Benefit
Accepted as reference-country evidence supporting the conformity assessment, but the MDA publishes no shorter period for it
Timeline Savings
None published
Authority
EU CE Mark
Accepted
Yes
Benefit
Accepted as reference-country evidence supporting the conformity assessment, but the MDA publishes no shorter period for it
Timeline Savings
None published
Authority
ASEAN member-state registration
Accepted
No
Benefit
There is no ASEAN mutual recognition agreement for device registration — the AMDD harmonises the dossier, not the decision
Timeline Savings
None

Key Requirements

Malaysia Authorized Representative (MAR)
English/Malay labeling
ISO 13485 certification
Free Sale Certificate
MDAR registration
Applicant clocks (MDA/GD/0070 cl. 6.2-6.3): mandatory information within 30 working days of request (refusal ground); other additional information within 90 working days
Establishment licence processed in 14-21 working days; CAB verification-assessment stages per Annex 2 Table 6

Local Rep Required

Yes

Local Rep Name

Malaysia Authorized Representative (MAR)

Mdsap Accepted

Mdsap Benefit

Not formally recognized but ISO 13485 accepted

Registration Validity

5 years

Verification Status

official-verified

Official Sources

Title
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
Url
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
Accessed Date
2026-08-25
Title
ACCSQ Medical Device Product Working Group — Implementing the ASEAN Medical Device Directive: "Not intended to confer mutual recognition; each member state retains sovereign right for registration decisions"
Url
https://www.ahwp.info/sites/default/files/6%20Implementing%20the%20ASEAN%20Medical%20Device%20Directive%201.0.pdf
Accessed Date
2026-08-30

Reviewed On

2026-08-30

Last Updated

2026-08-30

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by MDA. Appoint a Malaysia Authorized Representative (MAR).
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to MDA including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
MDA reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. MDA may issue questions.
Duration
14-20 working days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, MDA issues Malaysia market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Malaysia fees →

Country

Malaysia

Jurisdiction Id

malaysia

Country Code

Authority

MDA

Low Risk Local

Min: 1250
Max: 1250
Currency: MYR
Per Product: Yes

High Risk Local

Min: 2500
Max: 3750
Currency: MYR
Per Product: Yes

Details

Id
application-fee-class-a
Item
Registration application fee - Class A
Currency
MYR
Amount Local
500
Amount Local Formatted
MYR 500
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://portal.mda.gov.my/index.php/documents/ukk/3859-pua-330-2025-2/file
Source Title
Malaysia Medical Device (Amendment) Regulations 2025, P.U. (A) 330
Source Effective Date
2026-01-01
Verified On
2026-08-25
Id
application-fee-class-b
Item
Registration application fee - Class B
Currency
MYR
Amount Local
250
Amount Local Formatted
MYR 250
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
application-fee-class-c
Item
Registration application fee - Class C
Currency
MYR
Amount Local
500
Amount Local Formatted
MYR 500
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
application-fee-class-d
Item
Registration application fee - Class D
Currency
MYR
Amount Local
750
Amount Local Formatted
MYR 750
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
registration-fee-class-a
Item
Registration fee (on registration) - Class A
Currency
MYR
Amount Local
750
Amount Local Formatted
MYR 750
Frequency
Per registration, 5-year validity
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://portal.mda.gov.my/index.php/documents/ukk/3859-pua-330-2025-2/file
Source Title
Malaysia Medical Device (Amendment) Regulations 2025, P.U. (A) 330
Source Effective Date
2026-01-01
Verified On
2026-08-25
Id
registration-fee-class-b
Item
Registration fee - Class B
Currency
MYR
Amount Local
1000
Amount Local Formatted
MYR 1,000
Frequency
Per registration, 5-year validity
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
registration-fee-class-c
Item
Registration fee - Class C
Currency
MYR
Amount Local
2000
Amount Local Formatted
MYR 2,000
Frequency
Per registration, 5-year validity
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
registration-fee-class-d
Item
Registration fee - Class D
Currency
MYR
Amount Local
3000
Amount Local Formatted
MYR 3,000
Frequency
Per registration, 5-year validity
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
registration-fee-medicinal-product-device
Item
Registration fee - device incorporating a medicinal product
Currency
MYR
Amount Local
5000
Amount Local Formatted
MYR 5,000
Frequency
Per registration, 5-year validity
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
establishment-application-per-role
Item
Establishment-licence application fee (per role: manufacturer, AR, distributor, importer)
Currency
MYR
Amount Local
250
Amount Local Formatted
MYR 250
Frequency
Per role
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
establishment-licence-manufacturer
Item
Establishment licence - manufacturer
Currency
MYR
Amount Local
4000
Amount Local Formatted
MYR 4,000
Frequency
Per licence
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
establishment-licence-authorised-representative
Item
Establishment licence - authorised representative
Currency
MYR
Amount Local
4000
Amount Local Formatted
MYR 4,000
Frequency
Per licence
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
establishment-licence-distributor
Item
Establishment licence - distributor
Currency
MYR
Amount Local
2000
Amount Local Formatted
MYR 2,000
Frequency
Per licence
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
establishment-licence-importer
Item
Establishment licence - importer
Currency
MYR
Amount Local
2000
Amount Local Formatted
MYR 2,000
Frequency
Per licence
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
establishment-renewal-application-per-role
Item
Establishment-licence renewal application fee
Currency
MYR
Amount Local
200
Amount Local Formatted
MYR 200
Frequency
Per role
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
establishment-renewal-manufacturer-or-ar
Item
Establishment-licence renewal - manufacturer or authorised representative
Currency
MYR
Amount Local
2000
Amount Local Formatted
MYR 2,000
Frequency
Per renewal
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
establishment-renewal-distributor-or-importer
Item
Establishment-licence renewal - distributor or importer
Currency
MYR
Amount Local
1000
Amount Local Formatted
MYR 1,000
Frequency
Per renewal
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
cab-registration-application
Item
Conformity-assessment-body registration application
Currency
MYR
Amount Local
1500
Amount Local Formatted
MYR 1,500
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
cab-registration
Item
Conformity-assessment-body registration
Currency
MYR
Amount Local
8000
Amount Local Formatted
MYR 8,000
Frequency
Per registration
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
export-permit
Item
Export permit
Currency
MYR
Amount Local
100
Amount Local Formatted
MYR 100
Frequency
Per permit
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
appeal
Item
Appeal
Currency
MYR
Amount Local
250
Amount Local Formatted
MYR 250
Frequency
Per appeal
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25
Id
advertising-approval
Item
Advertising-approval processing fee
Currency
MYR
Amount Local
1000
Amount Local Formatted
MYR 1,000
Frequency
Per advertisement
Notes
Medical Device (Advertising) Regulations 2019 reg. 2(3)(b).
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Source Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Verified On
2026-08-25

Notes

Fees follow the Medical Device Regulations 2012 Fifth Schedule as amended by P.U.(A) 330/2025 from 1 January 2026: Class A application rose from RM100 to RM500 and a Class A registration fee of RM750 was introduced.
Application and registration fees are cumulative per device; establishment licences are billed per role.
Conformity-assessment-body charges are separate commercial fees.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
Malaysia Medical Device (Amendment) Regulations 2025, P.U. (A) 330
Url
https://portal.mda.gov.my/index.php/documents/ukk/3859-pua-330-2025-2/file
Effective Date
2026-01-01
Accessed Date
2026-08-25
Title
Malaysia Medical Device Regulations 2012, Fifth Schedule fee table
Url
https://www.mda.gov.my/documents/dmdocuments/Medical%20Device%20Regulations%202012.pdf
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Malaysia certifications →

Slug

malaysia

Market

Malaysia

Confidence

low

Schemes

Id
mda-electrical-emc-evidence
Name
MDA electrical/EMC evidence
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
MDA/GD/0070 Annex 4: active devices need electrical-safety, mechanical/environmental-protection and EMC evidence (IEC 60601-1 series test summaries, reports or certificates); QMS certificates per ISO 13485 or equivalents (MDSAP, US FDA QSR, Japan MHLW Ordinance 169; ISO 9001 only for Class A empty gas cylinders); clinical investigational plans per ISO 14155; Class A QMS verification covers sterility maintenance and metrology compliance for measuring functions (Third Schedule MDR 2012 para 6(2)(a)).
Source Urls
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
Source Binding
candidate
Id
mcmc-sirim-communications-product-certification
Name
MCMC/SIRIM communications product certification
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Communications Multimedia Or Hybrid Product
Source Urls
https://www.sirim-qas.com.my/service/communication-multimedia-and-hybrid-product/
Source Binding
candidate
Id
jakim-medical-device-halal-certification
Name
JAKIM medical-device halal certification
Category
Halal And Material Origin
Status
Voluntary Or Procurement
Object
Eligible Material Risk Device
Source Urls
https://www.halal.gov.my/index.php?content_id=202203306243ae3925019&data=bW9kdWxlcy9jb250ZW50X2RldGFpbHM7Ozs%3D&page_title=Announcement
Source Binding
candidate
Id
atom-class-c-irradiating-apparatus-licence
Name
Atom Malaysia Class C irradiating-apparatus licence
Category
Ionizing Radiation
Status
Mandatory If Feature
Object
Product And Use Site
Note
Act 304 and the Radiation Protection (Licensing) Regulations 1986 regulate radiation generators; Atom Malaysia lists Class C for irradiating apparatus. Read the 2011 Act reprint together with Act A1779: its section 9 updates Act 304 section 12(3), including the eligible medical professionals, while sections 13–14 replace the Board with the Director General in sections 15–16. Applications for a medical purpose are referred to the Director General of Health; doubtful medical/non-medical classification is referred to the Advisory Council under section 16(4a). The current licence catalogue lists an RM 15 application fee and a licence fee by category. Act A1779 received royal assent on 20 November 2025. P.U. (B) 425/2025 commenced it on 1 December 2025 except sections 10, 15, 17, 18, 33 and 53. The new import/export/transit permit provisions are among those exceptions; do not treat their enactment or the general commencement date as proof that a specific permit provision is in force.
Source Urls
https://www.atom.gov.my/en/license-application
https://www.atom.gov.my/wp-content/uploads/2024/04/Act-304-Atomic-Energy-Licensing-Act-1984.reprint-2011.pdf
https://www.atom.gov.my/wp-content/uploads/2025/12/A1779-ATOMIC-ENERGY-LICENSING-AMENDMENT-ACT-2025.pdf
https://www.atom.gov.my/wp-content/uploads/2025/12/PUB-425_2025-Penetapan-Tarikh-Permulaan-Kuat-Kuasa.pdf
Source Binding
reviewed
Id
mda-establishment-import-licence
Name
MDA establishment import licence
Category
Import Conformity
Status
Mandatory At Import
Object
Commercial Importer
Note
Medical Device Act 2012 (Act 737) s.15 requires an establishment licence for importing, exporting or placing registered medical devices on the market. Under MDA General Order No. 1 of 2024 (single-license policy), new applications have been limited to one establishment role since 16 February 2024, with full policy implementation from 1 July 2024. An authorised representative (AR) that also imports must obtain the corresponding importer licence; an AR licence does not automatically authorise importing under the single-role policy. Existing multiple-role licences transition to separate licences at renewal during the 2024–2027 implementation period; check the roles and validity of the actual licence. Importers are appointed by the AR to import its registered devices. Applications go through MeDC@St and the applicable GDPMD requirements must be met.
Source Urls
https://portal.mda.gov.my/index.php/industry/establishment-licence/establishment-license-information
https://www.mda.gov.my/index.php/faq/single-license-policy-implementation
Source Binding
reviewed

Official Sources

Authority
SIRIM QAS
Topic
communications, multimedia and hybrid product certification
Url
https://www.sirim-qas.com.my/service/communication-multimedia-and-hybrid-product/
Authority
JAKIM
Topic
medical-device halal certification scheme
Url
https://www.halal.gov.my/index.php?content_id=202203306243ae3925019&data=bW9kdWxlcy9jb250ZW50X2RldGFpbHM7Ozs%3D&page_title=Announcement
Authority
MDA
Topic
MDA/GD/0070 conformity assessment verification submission guide
Url
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
Authority
Jabatan Tenaga Atom (Atom Malaysia)
Topic
Act 304 licence classes including Class C irradiating apparatus via elesen-eSPP
Url
https://www.atom.gov.my/en/license-application
Authority
MDA
Topic
Establishment licence — Act 737 s.15(1) import/export/place-in-market requirement and importer role
Url
https://portal.mda.gov.my/index.php/industry/establishment-licence/establishment-license-information
Authority
MDA
Topic
MDA establishment import licence — single-license policy, separate AR/importer roles, implementation dates and renewal transition
Url
https://www.mda.gov.my/index.php/faq/single-license-policy-implementation
Authority
Jabatan Tenaga Atom (Atom Malaysia)
Topic
Act 304 radiation-generator licensing — principal Act, read with Act A1779 and its commencement notice
Url
https://www.atom.gov.my/wp-content/uploads/2024/04/Act-304-Atomic-Energy-Licensing-Act-1984.reprint-2011.pdf
Authority
Jabatan Tenaga Atom (Atom Malaysia)
Topic
Act A1779 radiation-generator licensing amendments — sections 9, 13 and 14 update Act 304 sections 12, 15 and 16
Url
https://www.atom.gov.my/wp-content/uploads/2025/12/A1779-ATOMIC-ENERGY-LICENSING-AMENDMENT-ACT-2025.pdf
Authority
Jabatan Tenaga Atom (Atom Malaysia)
Topic
Act A1779 commencement — P.U. (B) 425/2025 excludes sections 10, 15, 17, 18, 33 and 53 from 1 December 2025 commencement
Url
https://www.atom.gov.my/wp-content/uploads/2025/12/PUB-425_2025-Penetapan-Tarikh-Permulaan-Kuat-Kuasa.pdf

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Pricing

Changes after registration

Change control

Transfer of the registration between ARs

Logo and other label edits

Combining changes and pending applications

Manufacturer name and administrative office changes

Name and registered identifier changes

Dossier requirements

AR transfer documents, fee and timing

Documents for manufacturer name or office CN

Evidence for a name or identifier CN

Fees

Change-notification fees by category and ID

Label, IFU & language

Labels must stay aligned with the registered device

Reliance & recognition

Malaysia approvals and evidence in other markets (0 records)

Prior approvals and evidence for Malaysia (9 records)

FDA 510(k)

Malaysia-China Phase 2 joint evaluation: excludes already registered devices

ASEAN Medical Device Directive (AMDD) harmonisation

ASEAN member-state registration

Class B

China NMPA approval: not reference

Class C

Class D

EU CE Mark

Review clocks

CN review targets and implementation points

Source provenance & time

GD0020 remains the conditional current basis

Related structured datasets

More Malaysia medical device resources