Registration, Licensing & Enforcement Division

FUNCTIONS OF REGISTRATION, LICENSING 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;
  • Develop, plan, coordinate and implement surveillance and vigilance activities pertaining to safety and performance of the medical devices and establishments’ obligations in the post-market phase through:-   

i -   complaints on safety and performance of medical devices

ii -  mandatory problem reportingiii - field corrective actions

iv - recall

  • Develop, plan, coordinate and implement enforcement activities including;-

i - Inspection,

ii - Intelligence and investigation,

iii - Search and seizure

iv - Prosecution

The Registration, Licensing, and Enforcement Division is divided into 2 branches namely:- 

i - Registration & Licensing Branch consisting of 3 units namely the Medical Devices Registration Unit, Compliance Assessment Agency Registration Unit and Establisment Licensing Unit,

ii - Surveillance and Enforcement Branch comprising 2 units namely the Post Market Surveillance & Vigilance Unit and Enforcement Unit


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

Post Market & Surveillance 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.

Thus, among the main activities in the Medical Device Authority is to monitoring post market surveillance & vigilance. This is based on the requirements of Act 737 under Part III of Chapter 3 of duties and obligations of the Licensee or Permit Holder. The main objective of post market surveillance and vergilance activities is to ensure that medical devices are safe and effective for use. This activity is one of scope in the Division of Registration, Licensing and Enforcement and under the supervision of Post Market Survillance & Vigilance Unit (PMSV).

To achieve these objectives, PMSV Unit has implemented a number of major events such as below:

  1. Management and monitoring of medical devices complaints.
  2. Management and monitoring of Mandatory Reporting Problems involving medical devices.
  3. Management and monitoring of field corrective action (Field Corrective Action) and (Field Safety Notice) involving medical devices.
  4. Management and monitoring Recall medical devices.
  5. Management and monitoring of advertising complaints involving medical devices.
  6. Monitoring complaints involving medical devices that claimed to be artificial.

Post market activities provide an opportunity to get preliminary information and enable remedial action such as improvements or recall the device is designed to address the medical device in question. The next activity is the dissemination of information in advance so that the problems that will inevitably recur.

Post market activities provide an opportunity for identification and remedial action for problematic medical devices, product modification or product recall, as well as allow for timely dissemination of information that is necessary to prevent recurrence of similar problem.

In the post-market surveillance system, the establishment is required to create a system that can collect data post market surveillance of medical devices. Requires the establishment of mandatory reporting problems to report problems to the mandatory Medical Device Authority in accordance with the elements in Section 40 of Act 737.

The establishments are required to investigate and carry out follow-up actions, or initiate a product recall (if necessary and applicable), and report the results to the Medical Device Authority.

Healthcare professionals and users are also encouraged to notify the establishments of adverse incidents. Injuries arising from the use of medical devices by non-health professionals should also be reported. In some cases, the instruction for use or labeling are unclear which lead to detrimental circumstances.

Print