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MDSAP Recognition

What is MDSAP?​

The Medical Device Single Audit Programme (MDSAP) is a programme developed under the International Medical Device Regulators Forum (IMDRF) that allows a single audit of a medical device manufacturer's quality management system to satisfy the regulatory requirements of multiple participating countries.

MDSAP participating regulatory authorities include:

  • Australia (TGA)
  • Brazil (ANVISA)
  • Canada (Health Canada)
  • Japan (PMDA/MHLW)
  • United States (FDA)

Malaysia's Recognition of MDSAP​

Malaysia (MDA) is not a full MDSAP participating authority but recognises MDSAP audit results as supporting evidence for QMS assessment in Malaysian device registrations.

A current MDSAP certificate from an MDSAP-recognised Auditing Organisation (AO) can:

  • Supplement or replace a standalone ISO 13485 certificate in some cases (MDA discretion)
  • Reduce the need for additional GMP audits by MDA for MDSAP-certified manufacturers
  • Strengthen the quality evidence component of a registration dossier

How to Leverage MDSAP in a Malaysian Submission​

  1. Include a copy of the current MDSAP certificate in the registration dossier
  2. Include the most recent MDSAP audit report summary (redacted for confidentiality as appropriate)
  3. State in the covering letter that the manufacturer holds MDSAP certification and request MDA's consideration of this in lieu of or in addition to ISO 13485 certification

MDSAP Certificate Requirements​

For MDA to accept an MDSAP certificate:

  • Must be current and not expired
  • Must be issued by an IMDRF-recognised MDSAP Auditing Organisation (AO)
  • The scope must cover the device type(s) and manufacturing activities relevant to the Malaysian registration
  • No outstanding critical non-conformances that have not been closed

Current Recognised MDSAP Auditing Organisations​

Recognised MDSAP AOs include (among others):

  • BSI Group
  • TÜV SÜD Product Service GmbH
  • SGS United Kingdom Ltd
  • Intertek Testing & Certification Ltd
  • UL LLC

For the current complete list, refer to the IMDRF MDSAP website.

Practical Benefit​

For manufacturers already MDSAP-certified (e.g. for US FDA or Canada Health Canada purposes), using the MDSAP certificate for Malaysian registration avoids the need for a separate ISO 13485 audit solely for Malaysian purposes. This is a meaningful time and cost saving, particularly for SMEs entering multiple markets simultaneously.

Verify Acceptance

MDA's acceptance of MDSAP in lieu of a standalone ISO 13485 certificate is at MDA's discretion and may depend on the scope and outcome of the audit. Always confirm with MDA via a pre-submission query if you intend to rely primarily on MDSAP rather than ISO 13485 for Class C or D registrations.