Which manufacturers are eligible to undergo an MDSAP Audit

Eligibility to participate in the MDSAP is currently limited to manufacturers that:

• market medical devices under their own name or market in at least one participating jurisdiction (i.e., “legal” manufacturers), AND
• are subject to quality management system (QMS) or good manufacturing practices (GMP) requirements of the participating jurisdiction(s) in which they market their medical devices.

A pilot program is currently underway to assess whether eligibility can be extended to certain types of Medical Device Organizations (MDOs) – MDOs are those organizations that are subject to QMS and GMP requirements in participating jurisdictions that do not market medical devices under their own name or mark (i.e, not a “legal” manufacturers). Examples of MDOs include contract manufacturers and specification developers.

Any extension of MDO eligibility confirmed through the pilot program will only be applicable under Brazilian, Japanese and US regulations. MDOs are not eligible to participate in MDSAP under Australian and Canadian regulations. Further information on each RAs regulations is available here.

Manufacturers in the MDSAP program must have a contract with an MDSAP recognized AO. AOs charge for their services and manufacturers must pay for the audits. The MDSAP RAs are not involved in the contracts or negotiations between manufacturers and AOs. The cost of conducting an MDSAP audit is dictated by the commercial agreement between the manufacturer and the AO.