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Pre-market division & Post-market and enforcement division

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Pre-market division & Post-market and enforcement division 

  • Develop, plan, coordinate and implement activities of assessment, review and approval of application for; 

i - registration of medical devices 

ii - registration of Conformity Assessment Body (CAB)

iii - licensing of establishment

  • Coordinate and implement technical advisory activities on registration of medical devices, registration of Conformity Assessment Body (CAB) and licensing of establishment;
  • Assuring safety throughout the lifespan of a medical device at the post-market stage
    • complaints on safety and performance of medical devices
    • mandatory problem reporting
    • field safety corrective action
    • medical device recall
  • Develop, plan, coordinate and implement enforcement activities including; -

i - Inspection,

ii - Intelligence and investigation,

iii - Search and seizure

iv - Prosecution

iii - Search and seizure

iv - Prosecution

 


Registration Unit

Functions of Registration Unit are as follows:

  • To helps register of medical devices
  • To manage registration of establishment
  • To manage registration of Conformity Assessment Bodies

Establishment Licensing

Functions of Establishmen Licensing are as follows:

  • Strengthening the implementation of the evaluation activities for establishement licensing application
  • Implementing the evaluation activities on the amendment of the establishement licensing application

 


CAB Unit

What is a CAB?

A body authorized by the Authority to perform specified conformity assessment activities to determine whether the relevant requirements in technical regulations or standards are fulfilled. CAB is independent of the organization that provides the product and is not a user of the product (3rd party) and Authority will monitor the performance of the CAB and, if necessary, withdraw authorization.


Enforcement Unit

The activities carried out to implement enforcement functions are as follows:

  1. The preparation of the implementation framework of enforcement
  2. Development of Standard Operating Procedures (SOPs) and guidelines on enforcement
  3. Management of complaints of non - compliance requirements of Act 737
  4. Management and implementation of training programs and awareness of enforcement activities
  5. Creating and strengthening the cooperation with other enforcement agencies either within or outside the Ministry of health

 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

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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 
 

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  • Last Updated: 29 November 2023.
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