Definition: A Conformity Assessment Body (CAB) is an organization registered and recognized by Medical Device Authority (MDA) under the Medical Device Act 2012 (Act 737) in Malaysia. The CAB plays an important role in the regulatory framework for medical devices by conducting various conformity assessments to ensure that medical devices comply with the applicable standards, regulations, or requirements. The conformity assessments conducted by CABs may cover various areas, including product safety, performance, and quality management systems. The ultimate goal is to ensure that medical devices placed on the market are safe and perform as intended by the manufacturer and, therefore conforms to essential principles of safety and performance for medical devices.


Applicable Documents

Guidance Documents: Attachment 1

Application Checklist for CAB Registration: Attachment 2

Approval Process Flow for CAB Registration: Attachment 3

How to Create MeDC@St Account: Attachment 4

Online Application for CAB Registration: MeDC@St 2.0

Frequently Ask Questions (FAQs): Attachment 5


CAB Registry

List of Registered Conformity Assessment Bodies: Attachment 6

List of Registered Auditors and Technical Personnel: Attachment 7

List of Medical Device Technical Area (MDTA) vs. Auditors/Technical Personnel: Attachment 8

List of Technical Expert: Attachment 9


CAB Proficiency Trainings

Proficiency Training Types: Attachment 10

Proficiency Training Calendar: Attachment 11

Proficiency Training Syllabus: Attachment 12

Proficiency Training for Existing Personnel Analysis Report (January 2024): Attachment 13

Proficiency Training for Existing Personnel Analysis Report (May 2024): Attachment 14


MDA-CAB Workshop Outcomes

MDA-CAB Workshop 2023: Attachment 15

MDA-CAB Workshop 2024 (Series I): Attachment 16

Implementation OF MDA-CAB Workshop 2024 Outcomes: Attachment 17


Contact Details

Any inquiries, please email to: [email protected]

Contact numbers of relevant officers:

(1) Mohd Fadhullah Bin Abd Halim (Mr.) | Tel: +603-8230 0356 | E-mail: [email protected]

(2) Remee Binti Awang Jalil (Pn.) | Tel: +603-8230 0372 | E-mail: [email protected]

(3) Mohamad Sahafie Bin Zainal (Mr.) | Tel: +603-8230 0361 | E-mail: [email protected]


Important Notices

[For new organization seeking to become Conformity Assessment Body]

  • Prospective Conformity Assessment Bodies (CABs) are invited to carefully review and follow the outlined application procedures and stipulated requirements, which are available for review through this website page.
  • Prospective CABs are expected to uphold principles of independence and impartiality throughout their operations. Avoiding conflicts of interest and maintaining objectivity during conformity assessments are critical.
  • Prospective CABs are required to establish and maintain a robust Quality Management System (QMS) in accordance with MDA/GD/0023.
  • Prospective CABs should be aware of the expected timeline for the evaluation of their applications. Information on the evaluation process, including potential site visits or inspections, is available for review through this website page.