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Finding Harmony in a New Auditing Program

Ramaley stresses the need for a single credible and transparent accreditation process for medical device manufacturers worldwide.

The quest to harmonize medical device regulations isn’t simple. One area that poses a potentially large threat to the global device trade is foreign inspections. While many countries use ISO 13485 as part of their auditing criteria, countries such as Japan and some in Europe have add-on requirements. Other nations don’t recognize ISO 13485 certificates at all. Having a single inspection and certification system could simplify matters for device companies worldwide.

A new program, the ISO 13485 International Accreditation Forum (IAF) Medical Device Conformity Assessment System (MDCAS), seeks to address this issue. IAF member accreditation bodies are located throughout six continents, and the program aims to be the most accessible and credible accreditation for quality management systems, according to Grant Ramaley, chair of the IAF MDCAS working group. The first draft of a guidance document was completed last October, and it could go to a vote for approval within 12 months. 

“It’s inevitable that something like this has to be created, because if regulators [are] going to harmonize regulations the way the GHTF [Global Harmonization Task Force] wants them to, they will have third-party inspections,” says Ramaley, who is also director of regulatory affairs at Aseptico Inc. “If regulators don’t have access to audit reports as well as transparency and confidence in the audits, they’re going to feel like they’re jeopardizing the public health system that they’re supposed to be protecting.”

So far, Ramaley hasn’t seen many comments on the first draft of the document and attributes this to the solid medical device expertise that the working group had in putting together the draft. “We’re taking the existing requirements that the GHTF had already created and are mixing them with the ISO standards for accreditation,” says Ramaley, adding that the group is creating levels of transparency that don’t currently exist.

In addition to transparency, the strongest part of the document is its accreditation requirements, which ensure that auditors have certain levels of experience, training, and competencies relative to medical devices and regulations, and that they have sufficient independence. Incorporating GHTF requirements into the accreditation standard strengthens the credibility of the audit. “Because we’re standardizing the approach to how the certification bodies are performing, you can make sure that the auditors are performing the audit in the same way [around] the world,” says Ramaley. “If they don’t and they get caught, the IAF could withdraw their accreditation under the system. The level of enforcement behind [the program] is also key.”

The working group has been collaborating with countries from Brazil to China to Egypt to discuss the new program. Once the document is approved and available for accreditation bodies to use, a transition period of two to three years will play an important role in the program’s success. Despite the time it will take to implement the program, Ramaley says the adoption of it will be inevitable for the device industry. “Over the next 10 years, as countries develop, I think they will have no choice but to look seriously at using this program if they are going to have a harmonized medical device regulation,” says Ramaley.

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