Benefits and Use
Benefits
MDSAP was developed to encourage and support global harmonization of regulatory systems, where possible, to increase efficiency and reduce duplication of effort. It achieves this through ensuring the highest standards of safety for medical devices, whilst minimizing regulatory burden through use of an agreed single audit process.
Specifically, MDSAP aims to:
Enable appropriate regulatory oversight of medical device manufacturers’ Quality Management Systems (QMS) while minimising regulatory burden on industry
Promote more efficient and flexible use of regulatory resources through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each RA
Promote globally, in the longer term, a greater alignment of regulatory approaches and technical requirements based on international standards and best practices
Promote consistency, predictability, and transparency of regulatory programs by:
- standardizing the practices and procedures of participating regulators for the oversight of third-party AOs
- leveraging, where appropriate, existing requirements and procedures for conformity assessment, and
- standardizing the practices and procedures of participating third-party AOs.
Each MDSAP RA uses the program and its outputs in a different way and may also add additional requirements when their legislation requires such additions. MDSAP RAs remain the authority for marketing authorization within their jurisdictions.
Further information on how MDSAP is used by each participating MDSAP organization is provided below.
Australia’s TGA currently uses MDSAP audit reports and certificates as part of the evidence that is assessed for compliance with medical device conformity assessment procedures and market authorization requirements, unless the medical device is otherwise excluded or exempt from these requirements or if current policies restrict the use of MDSAP audit reports. Further details are provided in the 'Use of market authorisation evidence from comparable overseas regulators/assessment bodies for medical devices (including IVDs)' guidance.
For MDSAP certificates and audit reports to be considered by the TGA, the Australian regulatory requirements must have been covered in the audit(s), and certificates must show that the manufacturer has been assessed and found to comply with the relevant aspects of the Therapeutic Goods (Medical Devices) Regulations 2002.
ANVISA utilizes the outcomes of the program, including the reports, to constitute an important input to ANVISA’s pre-market and post-market assessment procedures, providing, when applicable, key information that is expected to support regulatory technical evaluation on these issues.
As defined in RDC 15/2014 and RE 2.347/2015, ANVISA may use MDSAP audits in lieu of a premarket inspection by ANVISA to grant ANVISA’s GMP Certificate to manufacturers intending to put medical devices of class III or IV on the Brazilian market. Undergoing an MDSAP audit may accelerate ANVISA´s GMP certification process, which is a pre-requisite to the marketing authorization.
ANVISA can also use MDSAP audits to renew ANVISA’s GMP Certificate every four years, as an alternative to an ANVISA comprehensive inspection.
All manufacturers holding medical device licences in Canada participate in MDSAP. MDSAP certification is required to obtain a Class II, III or IV medical device license, pursuant to section 32 of the Medical Devices Regulations.
When an MDSAP audit report is submitted at the timing of premarket or periodical post-market QMS inspection application, Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) will use the report:
To exempt a manufacturing site* from on-site inspection, and/or
To allow a Marketing Authorization Holder (MAH) to substitute considerable part of documents required for the inspection with the report.
Note: PMDA may perform on-site inspections or request additional QMS documents, when it is determined necessary after a review of the MDSAP audit report package.
*Exceptions:
A Registered Manufacturing Site (RMS) which manufactures medical devices made of human /animal tissues.
A RMS which manufactures radioactive IVDs.
An establishment of a MAH.
The USFDA Center for Devices and Radiological Health, will accept the MDSAP audit reports as a substitute for FDA routine inspections. Additional benefits include:
MDSAP routine audits are announced, scheduled by the AO with the manufacturer, with a pre-established duration.
The FDA will review MDSAP audit reports with a level of scrutiny commensurate to the significance of audit findings, taking into account the review and follow-up performed by the AO.
Firms have one month to provide their full response to critical nonconformities (grade 4 and 5) to the AO (as opposed to 15 working days following an FDA inspection).
Certification documents issued by the AO state compliance with applicable US regulations, which may provide a marketing advantage.
Note: Inspections conducted “For Cause” or “Compliance Follow-up” by FDA will not be affected by this program. Special inspections, such as the annual Risk Based Workplan inspection program may also not be affected by MDSAP. Moreover, this MDSAP program would not apply to any necessary pre-approval or post approval inspections for Premarket Approval (PMA) applications or to decisions under section 513(f)(5) of the Act (21 U.S.C. 360c(f)(5)) concerning the classification of a device.
Firms with activities related to the Electronic Product Radiation Control (EPRC) provisions of the Act will continue to be subject to FDA inspections for the EPRC activities. Manufacturers of products that are not subject to device inspections, i.e. drugs, biologics, etc., may also require an FDA inspection. Further information is available at Information for Manufacturers/Combination products.
Besides complying with the regulatory requirements in Health Products (Medical Devices) (Amendment) Regulations 2012, Health Sciences Authority (HSA) accepts MDSAP certificates as evidence of conformity to a quality management system for both product registration and dealer license applications to minimise regulatory burden. If clarifications are required during assessment, HSA may request for MDSAP audit reports as part of evidence for assessing conformity.
In the framework of the Prequalification of in vitro diagnostics, the WHO may recognize successful MDSAP - Version 018 2022-08-22 audits as acceptable evidence of QMS compliance with international regulations. This may result in either abbreviated or waived WHO inspection depending on the scope of audit.
When certain manufacturing sites submit MDSAP certificate and audit report during GMP audits, the Ministry of Food and Drug Safety (MFDS) grants exemptions from on-site audit and conducts a document-based review instead. However, MFDS may perform on-site GMP audit when it is determined necessary after a review of the MDSAP audit report.
For the QMS compliance document review (QSD) of foreign manufactures intending to export their medical devices to Taiwan, they may submit a related MDSAP audit report issued by recognized MDSAP AOs under the cooperation program to substitute certain required documents.
Note: TFDA may request additional QMS documents if deemed necessary after reviewing the MDSAP audit report. Additionally, TFDA may conduct on-site inspections based on a risk-based assessment.