Malaysian Draft Guidance Outlines Proposed Postmarket Audit Approach

April 10, 2015

Devicemakers up for routine postmarket surveillance audits in Malaysia will get at least two weeks’ notice, the country’s Medical Device Authority says.

A draft guidance, released last week, explains postmarket audits Malaysia is putting in place as part of ongoing efforts to implement its 2012 medical device regulations (IDDM, March 27). The MDA may audit devicemakers either as part of proactive surveillance or for cause. Specific reasons to initiate an audit include:

  • Concerns raised by vigilance issues;
  • Changes in legislation;
  • Complaints about marketed products;
  • Sampling across a specific technology or sector;
  • Receipt of information from internal or external sources; or
  • Requests from other regulatory authorities.

The list is not exhaustive, but meant as an outline of how postmarket surveillance audits are chosen, the MDA says. Issues that pose a public health concern are grounds for an immediate audit without prior notice, the authority adds.

After the MDA tells a manufacturer that it plans to audit its facilities, the authority will send a letter specifying the agreed-upon date and time and a list of areas the audit will cover. The regulator may also request some information before the audit, such as a brief company profile, a list of manufactured products or a high-level manufacturing flow chart.

Auditors will be looking for two types of noncompliance, major and minor. Major noncompliances are where failure to follow requirements poses a significant risk to public health or individual safety, while minor noncompliances pose a significantly lower risk. Inspections may also result in observations, which are concerns that do not require corrective action, the guidance says. Investigators will discuss observations and processes to fix them with the manufacturer.

On the day of the audit, an investigator will host a brief opening meeting to outline the audit plan and explain potential types of noncompliance. Concerns will be discussed with the manufacturer as they arise during the audit and a close-out meeting will be held to go over the findings. The manufacturer and investigator will set terms for a corrective action plan, if needed.

Following the audit, the MDA will issue a letter to the devicemaker once the corrective action plan generates a satisfactory response. If the authority doesn’t receive a satisfactory response, or if the devicemaker has breached the regulations, the MDA may take further enforcement action, the guidance says.

The guidance is still awaiting government sign-off, but should be finalized by the end of the year, says Zamane bin Abdul Rahman, chief executive of the MDA. It will take effect in 2016.

View the guidance at www.fdanews.com/04-13-15-malaysia.pdf. — Elizabeth Orr