Breadcrumb Home Frequently Asked Questions Audits FAQs Do manufacturers seeking MDSAP certification need to comply with regulations in jurisdictions where they do not market? Do manufacturers seeking MDSAP certification need to comply with regulations in jurisdictions where they do not market? Sidebar navigation Audits FAQs How can a manufacturer participate in the MDSAP? Does the MDSAP add requirements for the manufacturer? How does the MDSAP ensure medical devices are manufactured in accordance with multiple regulations? How does MDSAP ensure effort is not duplicated for manufacturers that sell in multiple jurisdictions? Does the audit process include daily review of areas of concern? Are MDSAP audits conducted by single or multiple auditors? Who assigns a particular auditor? Do manufacturers seeking certification need to comply with regulations in a jurisdiction where they do not market? Can MDSAP RAs void any audits by an AO due to inadequate audit method? If an AO issues a negative final report, can the manufacturer still sell in MDSAP jurisdictions? How do manufacturers show they have been successfully audited under the MDSAP? If a manufacturing site is already under regulatory action with an MDSAP RA, can they participate in the MDSAP? What happens to a manufacturer when the AO recognition is revoked? Can non-participating RAs have access to MDSAP audit reports? How can the veracity of certificates be confirmed? Is the CE certification included in the outcome of a successful MDSAP audit? What is the definition of a "campus" in the context of multi-site QMS audits? What is the primary benefit of the "campus" concept for multi-site organizations? Do audit tasks have to be repeated during a multi-site audit? How should AOs treat organizations with a legal address with no association to the company’s daily operations? Should a remote-audited facility be included on the certificate? How should AOs treat “virtual” manufacturers? How should AOs apply the audit approach when sites are not responsible for all QMS activities? When should AOs employ technical experts for audits? Under what circumstances would an MDSAP audit be followed by an RA inspection? Why have the MDSAP RAs imposed an initial response period of 15 calendar days? What are the requirements for transfer of certification for manufacturers? How long can an MDSAP certificate reference a jurisdiction where no product is distributed? Can the manufacturer exclude a jurisdiction or products from the scope of an MDSAP audit? What constitutes a counterfeit medical device or a fraudulent activity requiring notification of RAs? What is the expectation for Class I medical device manufacturers participating in the MDSAP? A manufacturer only needs to comply with the regulations of the countries where they intend to sell, actively sell, distribute, or make available for use their medical devices. If a medical device has valid marketing authorization in a country, it is considered intended for distribution in that country, even if no sales have occurred.If MDSAP certification is required before applying for marketing authorization, the manufacturer must inform the AO and request that the relevant country’s requirements be included in the audit. If the manufacturer does not proceed with marketing authorization application in that country after several years, the AO may recommend or decide to remove that country from the audit scope.