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 Vigilance Unit

Assuring safety throughout the lifespan of a medical device requires oversight of the use of the devices at the post-market stage. Post-market control is essential after a medical device has obtained market clearance. Monitoring the performance and reporting the problems associated with the use of medical devices are important components of regulatory control as failures or incidents arising from the use of a device could not be predicted or totally prevented at the pre-market stage.

Based on the requirements of Act 737 under Part III of Chapter 3 of duties and obligations of the Licensee or Permit Holder, it is vital for the Authority to monitor the post market surveillance and vigilance activities done by the establishment.

 The MDA Vigilance Unit carries out the following functions:

1.        Monitoring of medical devices complaints management.

2.        Monitoring of Mandatory Problem Reporting involving medical devices.

3.        Monitoring of field corrective action (Field Corrective Action) and (Field Safety Notice) activities.

4.        Monitoring of medical device Recall plans and activities.

5.        Monitoring any post market related activities that may affect the element of safety and performance involving medical device. 

6.        Monitoring of any safety and performance complaint and issue raised by the medical device users.

Post market activities provide an opportunity to get preliminary information and enable remedial action such as improvements of a medical device or to recall any defective device from the market. This is a platform where a dissemination of information in advance can be taken by the Authority to protect the public, and a medical device user.

All healthcare professionals and medical device users are encouraged to notify the establishments of any issue related to their medical device safety and performance.

In Malaysia, with the new regulations introduced in 2019, and with an online post market reporting being introduced since July 2022, a tougher guidelines and requirements for incoming medical devices should be anticipated, along with highly developed systems aimed at post market surveillance for devices available in the market.

Medical device establishment therefore, should put more efforts proportionate to these stringent guidelines to be imposed by MDA and also in other countries.

 

 

 

Updated: 15th February 2023