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. US FDA accepts the MDSAP for routine inspections.
Each audit ties up human resources and takes time for preparation, conducting the audit and follow-up. The annual costs of individual audits are also immense!
To address this situation, some countries have developed a joint international audit approach recognized in all partner countries: MDSAP - Medical Device Single Audit Program.
What Countries and Authorities are Part of the MDSAP?
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).
Potential savings through harmonization and a jointly recognized MDSAP audit can be realized with deliveries to only two of the aforementioned countries.
The Way to MDSAP Compliance - Determining Savings Potential and Supporting Realization
Even if only two of the countries mentioned are supplied, there is potential for savings. Because proofing compliance of the QM system for various institutions, obtaining country-specific certifications, and completing individual re-audits every year - all this means a great effort and sometimes enormous costs. gempex determines the possible savings potential and thus provides a secure basis for deciding whether participation in the MDSAP program brings advantages.
Once the decision has been made, 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
- High 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