What Are the Steps for Medical Device Registration in Malaysia?

Direct answer: Medical device registration in Malaysia is carried out under the Medical Device Act 2012 (Act 737). First confirm the risk classification (Class A/B/C/D), appoint a local Authorized Representative (AR) and obtain an Establishment Licence, obtain a conformity assessment report from a Conformity Assessment Body (CAB), submit the registration application through the MeDC@St system in CSDT format, and undergo MDA review and certification. The certificate is valid for 5 years and may be re-registered one year before expiry. The official review timeline is not publicly disclosed.

Key Requirements

• Competent authority: Medical Device Authority (MDA), a statutory body under the Ministry of Health — https://www.mda.gov.my/
• Applicable products: Medical devices classified by risk as Class A/B/C/D under the Act 737 classification rules.
• Core documents: (1) appointment of a local Authorized Representative (AR); (2) Establishment Licence; (3) CAB conformity assessment report/certificate; (4) technical file in CSDT format; (5) ISO 13485 / GDPMD quality management system evidence; (6) product labels and instructions for use; (7) Declaration of Conformity; (8) reference-country approvals, which may support the verification/abridged pathway.
• Certificate validity: 5 years; re-registration may be submitted 1 year before expiry.
• Local representative: Required. Foreign manufacturers must appoint a Malaysian Authorized Representative (AR).
• Official review timeline: Not publicly disclosed.

Regulatory Basis and Sources

• Medical Device Act 2012 (Act 737) — registration basis: Section 5(1) — https://www.mda.gov.my/index.php/industry/medical-device-registration/medical-device-registration-information
• Medical Device Regulations 2012 [P.U.(A) 500/2012].
• The MDA was established under the Medical Device Authority Act 2012 (Act 738).
• Verification date: 2026-10-30.

Frequently Asked Questions

Is a local Authorized Representative mandatory?

Yes. Foreign manufacturers must appoint a Malaysian Authorized Representative (AR), and the AR must hold an Establishment Licence.

What is CAB conformity assessment?

A Conformity Assessment Body (CAB) registered with the MDA assesses the product's quality management system and product conformity. Class B/C/D devices generally require a CAB report.

Is the process the same for Class A and Class B/C/D?

No. Class A follows a simplified pathway, while Class B/C/D requires CAB conformity assessment and a more extensive process.

How long is the registration certificate valid?

The certificate is valid for 5 years. Re-registration can be submitted through MeDC@St one year before expiry.

Can a CE certificate reduce the process?

In some cases, yes. A verification (abridged) pathway may be available using approvals from foreign regulatory authorities recognized by the MDA, reducing certain assessment requirements. Eligibility depends on MDA requirements.

Scope Note

This FAQ is for regulatory information only and does not replace the role of a Malaysian Authorized Representative or CAB assessment. Confirm current requirements with the MDA and your appointed AR/CAB.

Prepared by the Ameli Regulatory Editorial Team based on public pages of the Malaysian MDA. Verification date: 2026-10-30. Facts on this page are subject to official sources; figures not publicly disclosed are marked as not publicly disclosed.