opfvelo.blogg.se - april 2023

Surveillance Inspection – Conducted on registered CAB from time to time to ensure CAB continuously complies to condition of registration, CAB’s QMS is implemented according to Malaysia Regulatory Requirements and information submitted in the online system is up to date.

Pre-registration Inspection – Conducted on a company who wish to register as a CAB in Malaysia to ensure they are comply to Act 737 and Fourth Schedule of MDR 2012 prior to registration.

Types of inspections conducted as per below To ensure that the establishment and Conformity Assessment Body (CAB) continuously comply with the Act 737, Medical Device Regulation, condition of license / registration and other directives set by the MDA through the inspections

It is operated under the Policy, Code and Standards Division, Medical Device Authority (MDA). The Compliance Branch formerly known as the Audit Branch was established in 2012. 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. Policy, International Affairs and Industry Facilitation (DASAR) has been divided into 2 branches:.

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. POLICY, INTERNATIONAL AFFAIRS AND INDUSTRY FACILITATION (DASAR)

Policy, International Affairs and Industry Facilitation (DASAR)