Jul 10, 2020

Over the last two months, Malaysia’s Medical Device Authority (MDA) has issued three noteworthy guidance documents relating to post-market surveillance. These expand on the responsibilities of medical device establishments after bringing a product to market, as defined in the Medical Device (Duties and Obligations of Establishments) Regulations 2019, which are now effective as of July 1, 2020.

New guidances cover complaint handling, field corrective actions, and problem reporting                                                                                                      

Complaint Handling (MDA/GD/0011) specifies the requirements on complaint handling for all medical devices. It stipulates that medical device establishments are required to set up complaint handling procedures and maintain records of all complaints they have received. Along with details of these requirements, the document includes a flowchart for handling medical device complaints and a complaint form.

Field Corrective Action (FCA) (MDA/GD/0013) outlines the requirements for implementing and reporting FCAs. In addition to reporting the FCA to the MDA, establishments should also communicate the FCA to all stakeholders by means of a Field Safety Notice (FSN). The guidance includes a flowchart, FCA notification and report forms, and an FSN template.

Mandatory Problem Reporting (MDA/GD/0014) explains the requirements for the mandatory problem reporting of incidents involving medical devices as required by Section 40 of the Medical Device Act 2012 and Regulation 5(1) of the Medical Device (Duties and Obligations of Establishments) Regulations 2019. Generally, all establishments are required to submit a mandatory problem report to the MDA when incidents related to their medical devices (registered in Malaysia) have occurred.​ A mandatory problem reporting Form and an investigation Form are provided in the annexes of this guidance.​

Forms found on MDA website

Forms for reporting adverse events, FCAs, and recalls are also available separately for download on the MDA website:

Learn more about Malaysian medical device regulations at Emergo by UL:

Author

  • Timothy Herr

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