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Policy, Code & Standard Division

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FUNCTIONS OF POLICY, CODE AND STANDARD DIVISION

- Develop, plan, coordinate and implement;-

i - policy development and legal documents such as rules and regulations relating to the control of medical devices under the Medical Devices Act 2012 (Act 737),

ii - the development of guidance documents, codes and standards relating to the control of medical devices under the Medical Device Act 2012 (Act 737) and its rules in more detail,

iii - development of GLP recognized laboratory

- Develop, plan, coordinate and implement activities pertaining to multilateral cooperation and relationship between agencies within and outside the country,

- Develop, plan, coordinate and implement activities pertaining to industrial assistance

- Develop, plan, coordinate and implement compliance monitoring activities against legal requirements under Act 737 through audits and inspection.

The Policy, Code & Standard Division is divided into 2 branches:

i- Policy & Industrial Assistance Branch consisting of 3 units namely International Policy & International Unit, Code & Standard Development Unit and Industrial Assistance Unit,

ii- Compliance Audit Branch conducting CAB audit activities, product and premise quality management and regulatory audit.

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  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my