Policy, Code & Standard Division
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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