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COMPLIANCE AUDIT UNIT

The Compliance Audit Unit carries out audits of Establishment (Establishment comprise of Manufacturer, Authorised Representative, Distributor and Importer) and Conformity Assessment Bodies (CAB) on regular basis. The types of audits that are conducted are as follows:

  • Proactive post-market surveillance audits
  • ‘For- cause’ post-market surveillance audits
  • Custom-made medical device audits
  • Audit pertaining to register Conformity Assessment Body (CAB)
  • Audits pertaining to register of medical devices

The aim of these audits to ensure that the establishment and CAB is complying with the requirement of Medical Device Act 2012 (Act 737) and Malaysia Medical Device Regulation 2012 and other requirements specified by the Medical Device Authority (MDA).

Another key area in which the audit team is involved in is the surveillance of the medical device market to identify issues and trends in order to highlight priority areas for medical devices market.

Any enquiries please contact us or any of the following officers:

Chief Executive
Medical Device Authority (MDA)
Level 5, No 26, menara Prisma, Precinct 3
62675 Putrajaya, Malaysia

Tel: +603-8892 2400, Fax: +603-8892 2500

Contact Person: Mr. Hazman

 

 

Last Updated ( Wednesday, 16 March 2016 )
 
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