When a medical device manufacturer wants to export its products abroad, the applicable national regulations have to be followed in production and distribution, and certification by the respective authorities is required. This imposes a variety of requirements on the quality management system along with tremendous administrative effort.
After all, each audit procedure has its own requirements, the latest version of which must be observed and addressed in the QMS, including multiple compliance reviews. The classification of deviations may differ as well. Each audit ties up human resources and takes time for preparation, conducting the audit and follow-up. This has a significant influence on the company's operating performance. The annual costs of individual audits are also immense!
Australia, Brazil, Canada, Japan, and the USA have developed a joint international audit approach to address this situation – the Medical Device Single Audit Program (MDSAP). It is a uniform approach recognized in all member countries. This harmonization offers considerable relief regarding market access for companies that operate internationally.
What Countries and Authorities are Part of the MDSAP?
The MDSAP is an elegant way to provide proof of international quality management. It is lean and efficient. The MDSAP is based on the internationally recognized ISO 13485:2016 standard.
The following countries and their respective authorities accept the MDSAP as an option in their national procedure for placing medical devices on the market:
- Australien - Therapeutic Goods Administration (TGA)
- Brasilien - Agência Nacional de Vigilância Sanitária (ANVISA)
- Japan - Ministry of Health, Labour and Welfare (MHLW), Pharmaceuticals and Medical Devices Agency (PMDA)
- Kanada - Health Canada
- USA - U.S. Food & Drug Administration (US FDA)
Health Canada accepts MDSAP certificates for medical device approval or renewal applications only. The MDSAP meets the regulatory requirements for initial audits in Brazil, improving the chances of accelerated market approval.
Even though the EU is not an MDSAP member, the EU Medical Device Coordination Group (MDCG) has paved the way for the use of MDSAP audit reports in the course of surveillance audits (Guidance MDCG 2020-14, August 2020).
IMDRF and MDSAP Compliance - the Regulatory Perspective
The International Medical Device Regulators Forum (IMDRF) is an international consortium of regulatory agencies in various countries. The IMDRF describes the motivation for and objective of the MDSAP as follows:
“The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.”
“The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.”
The MDSAP ensures a uniform inspection approach. It makes the approval of medical devices more standardized and easier.
Is Participation in the MDSAP Worthwhile?
As an example, if a medical device manufacturer of a Class II product would complete QMS audits in all countries individually, total annual audit costs could exceed EUR 500,000. Potential savings through harmonization and a jointly recognized MDSAP audit can be realized with deliveries to only two of the aforementioned countries. That means less effort along with relief in terms of saving time and money.
Furthermore, the MDSAP eliminates the search for reliably translated national regulations in non-English foreign countries. Resources that had to be expended for individual QMS certifications can be used to elsewhere to generate value.
gempex determines the potential savings to establish a reliable basis for decision making.
The Way to MDSAP Compliance
gempex prepares customers individually for their MDSAP certification. A team of experts with many years of industry expertise understands, assesses, advises and assists from the very beginning.
The required measures in view of MDSAP compliance are defined and recommendations are made. Targeted, economical, custom-fit. On request, gempex also assists with the implementation of the measures, amends documents, establishes processes and revises SOPs Standard Operating Procedures and work instructions.
Up to accompanying the actual audit and handling communication with the Auditing Organization. The follow-up of the MDSAP audit and CAPA management – where applicable - can be supported as well.
A modular system of services to cover company’s needs. And to ensure MDSAP compliance.
Training of employees is also part of the service portfolio. For example, employees are prepared for a typical MDSAP audit or are trained in the classification of nonconformities. A mock-up audit can also be conducted, simulating realistically and practicing an MDSAP audit situation.
This fully prepares the customer for a MDSAP audit, establishing Audit Readiness.
Full service – from the idea to realizing the benefits
- Clear cost calculation and reliable decision-making basis
- Up to 90% reduction of the immense individual audit costs
- International expert knowledge in consultancy and implementation
- Modular selection of services from initial analysis to passing the MDSAP audit
- Amendment of processes and documents in the QMS
- Reliable knowledge of regulations and efficient implementation
- Purposeful communication with the Auditing Organizations
- On-the-job training of employees