The Audit & Surveillance Branch carries out audits of medical device manufacturers (as well as importers and distributors) on regular basis.  The type of audits that are conducted are as follows:

                        -  Proactive post market surveillance audits
                        -  Reactive post market surveillance audits
                        -  Custommade medical device audits
                        -  Other audits pertaining to the register of medical devices 

The aim of these audits is to ensure that the medical device manufacturer is complying with the essential requirements for safety and performance and other requirements specified by the MDB.  

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

Regulatory Auditing of Quality Management Systems (QMS) and Auditing Process

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

                                          Director,
                                          Medical Device Bureau, Ministry of Health Malaysia,
                                          Level 5, No. 26, Boulevard Plot 3C4, Precinct 3,
                                          62675 Putrajaya, MALAYSIA.
                                          Fax : +603-8885 0759 / 8885 0760

                                          E-mail  :  This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

                                          Tel :  +603-88850764   Puan Aidahwaty
                                          Tel :  +603-8885 0752   Puan Nashirah