Peter Rose, Managing Director Europe, Maetrics09.12.17
International regulators have long championed the introduction of a global approach to auditing and monitoring medical device manufacturing. Ten years ago, the International Medical Device Regulators Forum (IMDRF) initiated the preparation for the Medical Device Single Audit Program (MDSAP). The IMDRF recognized that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety on an international scale. As the trial period has come to an end, the program is officially active in five countries, but in the changing regulatory environment, it is hard for manufacturers to remain properly informed.
In short, MDSAP promotes the greater alignment of regulatory approaches and technical requirements while simultaneously encouraging consistency and transparency within regulatory programs. The idea is that MDSAP will manage and oversee a single audit program that will allow a single regulatory audit to satisfy the varying requirements in multiple jurisdictions. The MDSAP functional statement1 defines the policy as, “To jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers’ quality management systems.”
The international partners participating in the pilot include the Therapeutic Goods Administration (TGA) of Australia, Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, Japan’s Ministry of Health and Labour and Welfare (MHLW), and the U.S. Food and Drug Administration (FDA). The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) were official observers. MDSAP recognized Auditing Organizations (AO) are able to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulating authorities.
MDSAP Structure
In January 2014, the MDSAP participating countries started a trial of the single audit program and in June 2017, a report collated the outcomes of the prospective “proof-of-concept” criteria established to confirm the viability of the MDSAP2.
Typically, implementation of MDSAP takes place over three years and includes three different audits.
Non-Conformities
Non-conformities are typically graded on a scale of 1 to 5, with a grade of 1, 2, or 3 considered a minor non-conformity, and grades 4 and 5 being considered far more serious. If any audit finds one or more grade 5 non-conformities, two or more grade 4 conformities, a public health threat, or even fraudulent activity, it is the responsibility of the AO to inform Regulatory Authorities within five days. It is normal practice for the AO to then complete an unannounced visit six to nine months later in order to verify the appropriate actions have been put in place to correct previous flaws.
AOs are expected to provide the audit package, which includes the NC Grading, to the Regulatory Authority within 45 days following the end of the audit. The manufacturer must provide a remediation plan for each non-conformance within 15 calendar days of the date the non-conformity report was issued.
Benefits and Opportunities of MDSAP
The MDSAP is also a key opportunity for manufacturers as it is designed to cover the existing ISO 13485 standard and country specification. This means manufacturers complying with MDSAP will automatically find they are in-line with local regulations and ISO 13485. Manufacturers will also benefit from the standardization and harmonization within QMS and in other regulatory submissions.
In addition, as the MDSAP is built on multiple regulations combined from five participating countries, manufacturers who comply with the MDSAP will automatically comply with the regulations of all five countries, opening up opportunities as well as streamlining compliance efforts. Although the initial stages of implementation appear challenging, it is clear that the benefits the MDSAP will provide supersedes its constraints as the time and effort required to prepare for and respond to audits and inspections from various markets and jurisdictions will contract.
It is also expected that MDSAP will eventually provide a broader choice of third party AOs and subsequent market forces may tend to reduce the cost of AO services. Although currently, the number of AOs is not as large as expected, it’s possible that organizations other than the Notified Bodies will apply to be recognized as AOs.
Nation by Nation Overview
There are specific aspects that manufacturers selling products in each of the five counties involved in the MDSAP should consider.
Conclusion
MDSAP will significantly reduce the work for manufacturers and Auditing Organizations that work in or with the five countries that have trialed the program; one the main benefits of having to comply with a single program across five countries is that of working from a single action plan for compliance. Regulatory authorities, on the other hand, will be impacted by a radical change in audit methodology as the main challenge of MDSAP lies in being able to harmonize all regulatory requirements in varying markets. There are some stakeholders who are understandably being cautious about the MDSAP; however, the benefits for manufacturers largely outweigh its constraints, while simplification and transparency are key principles that should guide all regulation in the future to help improve products, processes, and patient outcomes.
Get more information on MDSAP and its benefits at this link.
References
1 MDSAP Functional Statement MDSP P0001.002 Version Date 2015-07-24.
2 Medical Device Single Audit Program, US Food and Drug Administration, July 2017.
In short, MDSAP promotes the greater alignment of regulatory approaches and technical requirements while simultaneously encouraging consistency and transparency within regulatory programs. The idea is that MDSAP will manage and oversee a single audit program that will allow a single regulatory audit to satisfy the varying requirements in multiple jurisdictions. The MDSAP functional statement1 defines the policy as, “To jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers’ quality management systems.”
The international partners participating in the pilot include the Therapeutic Goods Administration (TGA) of Australia, Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, Japan’s Ministry of Health and Labour and Welfare (MHLW), and the U.S. Food and Drug Administration (FDA). The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) were official observers. MDSAP recognized Auditing Organizations (AO) are able to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulating authorities.
MDSAP Structure
In January 2014, the MDSAP participating countries started a trial of the single audit program and in June 2017, a report collated the outcomes of the prospective “proof-of-concept” criteria established to confirm the viability of the MDSAP2.
Typically, implementation of MDSAP takes place over three years and includes three different audits.
- The Initial Audit: An essential documentation review, which determines the readiness of the audited company to undergo a Stage 2 audit, which is an implementation review of the ISO 13485 standard and regulations applicable to the participating countries. The idea behind it is to conduct a thorough review of the QMS in order to verify the products are safe, effective, and meet performance standards.
- The Surveillance Audit: If no significant changes have been made since the last audit, this surveillance audit does not need a Stage one audit. The purpose of the surveillance audit is to review the QMS to verify the products are safe, effective, and meet performance standards.
- The Recertification Audit: Conducted to evaluate a continuous effectiveness and suitability of the QMS satisfying all applicable standards and regulations. The recertification audit will also confirm the relevance and applicability of the QMS with the scope of certification and MDSAP specific requirements.
Non-Conformities
Non-conformities are typically graded on a scale of 1 to 5, with a grade of 1, 2, or 3 considered a minor non-conformity, and grades 4 and 5 being considered far more serious. If any audit finds one or more grade 5 non-conformities, two or more grade 4 conformities, a public health threat, or even fraudulent activity, it is the responsibility of the AO to inform Regulatory Authorities within five days. It is normal practice for the AO to then complete an unannounced visit six to nine months later in order to verify the appropriate actions have been put in place to correct previous flaws.
AOs are expected to provide the audit package, which includes the NC Grading, to the Regulatory Authority within 45 days following the end of the audit. The manufacturer must provide a remediation plan for each non-conformance within 15 calendar days of the date the non-conformity report was issued.
Benefits and Opportunities of MDSAP
The MDSAP is also a key opportunity for manufacturers as it is designed to cover the existing ISO 13485 standard and country specification. This means manufacturers complying with MDSAP will automatically find they are in-line with local regulations and ISO 13485. Manufacturers will also benefit from the standardization and harmonization within QMS and in other regulatory submissions.
In addition, as the MDSAP is built on multiple regulations combined from five participating countries, manufacturers who comply with the MDSAP will automatically comply with the regulations of all five countries, opening up opportunities as well as streamlining compliance efforts. Although the initial stages of implementation appear challenging, it is clear that the benefits the MDSAP will provide supersedes its constraints as the time and effort required to prepare for and respond to audits and inspections from various markets and jurisdictions will contract.
It is also expected that MDSAP will eventually provide a broader choice of third party AOs and subsequent market forces may tend to reduce the cost of AO services. Although currently, the number of AOs is not as large as expected, it’s possible that organizations other than the Notified Bodies will apply to be recognized as AOs.
Nation by Nation Overview
There are specific aspects that manufacturers selling products in each of the five counties involved in the MDSAP should consider.
- Canada: Beginning January 1, 2019, the Class II, III, and IV medical devices in Canada will follow MDSAP. The CMDCAS will be transferred to the MDSAP. In contrast to the other partners of the program where participation is voluntary, the MDSAP will be mandatory for the regulatory submission in Canada.
- Australia: Combination products and other medical devices are accepted by the MDSAP. The TGA can accept MDSAP certificates as support of evidence for compliance with the ISO 13485 standard, and may request additional documents.
- Brazil: The resolution from August 2015 allows MDSAP reports to be used as an alternative to an ANVISA inspection, but only when the previous ANVISA inspection was deemed satisfactory.
- U.S: The MDSAP can be an alternative to a FDA inspection, excluding combination products and PMA inspections. Certification documents issued by the AO must comply with applicable U.S. regulations.
- Japan: An MDSAP audit report submitted at the time of pre- or postmarket QMS inspection can be used as a trial to exempt some manufacturing sites from on-site inspection, and/or to allow the Manufacturer’s Marketing Authorization Holder (MAH) to substitute the MDSAP report for a considerable part of documents required for the inspection.
Conclusion
MDSAP will significantly reduce the work for manufacturers and Auditing Organizations that work in or with the five countries that have trialed the program; one the main benefits of having to comply with a single program across five countries is that of working from a single action plan for compliance. Regulatory authorities, on the other hand, will be impacted by a radical change in audit methodology as the main challenge of MDSAP lies in being able to harmonize all regulatory requirements in varying markets. There are some stakeholders who are understandably being cautious about the MDSAP; however, the benefits for manufacturers largely outweigh its constraints, while simplification and transparency are key principles that should guide all regulation in the future to help improve products, processes, and patient outcomes.
Get more information on MDSAP and its benefits at this link.
References
1 MDSAP Functional Statement MDSP P0001.002 Version Date 2015-07-24.
2 Medical Device Single Audit Program, US Food and Drug Administration, July 2017.