Malaysian Regulators Lay Out Post-Market Surveillance Audit Framework

Malaysia’s Medical Device Authority, responsible for overseeing the country’s medical device market, has published new draft guidance on post-market surveillance regulatory audits for manufacturers authorized to sell their products there.

Malaysia post-market surveillance audits for medical devicesAll manufacturers commercialized in Malaysia are subject to post-market surveillance audits, according to the MDA guidance. The MDA performs either proactive surveillance audits targeting specific categories of devices based on what the regulator “deems appropriate,” or for-cause audits in response to adverse events or other issues that require MDA follow-up in order to protect public health.

How post-market surveillance audits are initiated

The MDA has the authority to initiate post-market surveillance audits following a broad array of possible scenarios. These include changes in legislation pertaining to medical device market oversight; complaints received about registered devices; post-market surveillance sampling of a specific technology or device type; or requests from other medical device regulatory authorities.

Manufacturers will be notified by the MDA prior to proactive post-market surveillance audits, and should prepare documentation that includes lists of all devices they manufacture, details about their selected Conformity Assessment Bodies and manufacturing flow charts.

In cases where for-cause audits are required, the MDA may or may not notify manufacturers that audits will be necessary depending on whether the regulator determines that an audit must occur immediately or as soon as possible following a public health event.

Consequences

If MDA auditors find instances of noncompliance during post-market surveillance audits, manufacturers will need to take various corrective steps depending on the severity of the issues MDA identifies.

  • Major noncompliance: The manufacturer has not fully complied with the Medical Device Act 2012 and/or Malaysia’s Medical Device Regulations, which has caused or may cause a serious public health issue
  • Minor noncompliance: The manufacturer has not met all requirements of the Medical Device Act 2012 and/or Medical Device Regulations, but any violations pose significantly less public health risk than a major noncompliance issue would

Manufacturers found to be in major noncompliance will be required to take corrective actions within short timeframes (agreed upon by both the company and the MDA), while firms found to be in minor noncompliance will typically have less immediate deadlines in which to take corrective actions.

In some cases where no major or minor noncompliance issues are found, MDA auditors may raise observations that could require audited manufacturers to improve identified processes or procedures but that do not require corrective actions. 

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