Regulatory Focus™ > News Articles > Medical Device Audit Program Needs More Industry Involvement, Report Says

Medical Device Audit Program Needs More Industry Involvement, Report Says

Posted 21 September 2015 | By Zachary Brennan 

Medical Device Audit Program Needs More Industry Involvement, Report Says

A mid-pilot report on the international Medical Device Single Audit Program shows some progress, though work still needs to be done, particularly in terms of attracting industry participants before the expected operational launch in 2017, a recent report says.


Back in January 2014, the International Medical Device Regulators Forum (IMDRF), the regulators-only successor group to the Global Harmonization Task Force, launched a two-year pilot program to assess whether a regulatory audit of a medical device manufacturer conducted by a MDSAP-recognized auditing organization can fulfill the needs of multiple regulatory jurisdictions, including those in Australia, Brazil, Canada, Japan, and the US.

Mid-Pilot Results

The initial results from pilot show that the majority of the IMDRF’s objectives and proof of concept criteria are being met, particularly in terms of conducting the prerequisite audits.

And of the two objectives that have yet to be met, both of which involve Canadian Medical Device Conformity Assessment System (CMDCAS) auditing organizations, the report says that “it is anticipated that application reviews and assessments of the head offices of all eligible CMDCAS registrars will be complete prior to the conclusion of the MDSAP Pilot.”

As of 23 July 2015, approximately ten MDSAP audits of medical device manufacturers have been conducted; and six audit report packages have been received. The participating regulatory authorities are completing reviews of the reports that have been received to date.

Question Marks

However, the pilot program is in desperate need of attracting more medical device manufacturers. As of 23 July, 2015, only 45 manufacturing sites have requested to participate in the program, while IMDRF says about 330 manufacturing sites need to express an interest in participating in the program by the end of 2016 in order for the program to progress.

“Program participation by medical device manufacturers appears to be the primary challenge at the mid-pilot review. Manufacturer participation is vital for the success of the program,” the report says.

And perhaps the spike (see graph below) in manufacturing sites signing up in July will continue into 2016.


MDSAP Participating Manufacturer Sites
Source: Mid-Pilot Status Report


The report also notes that at a MDSAP forum in June, 15 specific areas of MDSAP program concerns were identified, including 46 specific tasks to address the concerns.

“Initial solutions to these concerns have been identified and Deliverable Development Teams have been assigned to investigate the feasibility of these solutions and propose final solutions,” the report adds.

For a number of other target goals, the report says it’s still “too early to project whether target goals will be met.”

MDSAP Mid-Pilot Status Report


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