Corrective action for medical devices in Malaysia – new guidance

2020-07-07T17:08:32+08:00 July 7th, 2020|Insight, Medical Regulation Updates, News & Events|
OSCAR system

A Field Corrective Action for medical devices Guidance Document (MDA/GD/0013) was released by the Medical Device Authority (MDA) in Malaysia at the end of June and came into operation on 1 July 2020. Previously, Field Corrective Action (FCA) was addressed in the legislation, P.U. (A) 318, The Medical Device (Duties and Obligations of Establishments) Regulations 2019.

Corrective action for medical devices can be defined as the action taken to eliminate the cause of non-conformities to prevent a recurrence. FCA can arise from post market surveillance information such as product complaints, incidents, market surveys and research development activities amongst others. These can include safety related field corrective actions taken by the manufacturer to reduce the risk of harm to patients, operators or others and/or to minimize recurrence of the event. FCA might also be required by the Authority in cases coming from mandatory problem reporting and for medical devices that are no longer in the market or that have been discontinued but could possibly still be in use (e.g. implants).

Manufacturers, Authorized Representatives, Distributors and Importers shall undertake corrective or preventive action in relation to their medical devices that have been imported and placed in the market. This may include:

  1. the return of a medical device to the manufacturer or its representative (recall);
  2. device modification due to potential non-conformity, which may include:
    • retrofit in accordance with the manufacturer’s modification or design change;
    • permanent or temporary change to the labelling or instructions for use;
    • software upgrades including those carried out by remote access; or
    • modification to the clinical management of patients.
  3. medical device exchange;
  4. medical device destruction; and
  5. specific advice given by establishments regarding the use of the medical device.

Determining the need for FCA is the responsibility of the manufacturer:

a) The manufacturer shall perform a risk assessment in accordance with ISO 14971. The Authority may instruct additional measures by the manufacturer or authorized representative to safeguard public health in case the Authority finds that the risk assessment performed by the manufacturer is deficient.

b) FCA could be triggered from the establishment’s post market surveillance information (product complaint, adverse incidents, etc.) that indicate an unacceptable increase in risk.

The establishment shall submit an FCA report to the Authority within 30 days of completing the FCA or such longer period as the Authority may allow. The Authority may close the FCA and notify the establishment in writing on its decision when all necessary actions have been undertaken and considered satisfactory.

Click here to read the guidance document on the field corrective action for medical devices in Malaysia.

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