Quality assurance and regulatory compliance are vital for medical devices industries around the world to ensure product safety and efficacy. To facilitate global cooperation and improve the efficiency of audit processes, the Medical Device Single Audit Program (MDSAP) was developed.
In this article, we will discuss MDSAP and its benefits for the medical device sector.
What is MDSAP?
Created in 2012, MDSAP is a global audit program that seeks to harmonize regulatory requirements and improve audit efficiency, reducing the duplication of efforts and resources. It allows health regulatory authorities in different countries to conduct joint audits of healthcare products and medical device manufacturers.
Which countries are part of the program?
MDSAP member countries are represented by their regulatory enforcement authorities, the main ones being:
- US Food and Drug Administration (FDA);
- European Medicines Agency (EMA);
- Brazilian Health Surveillance Agency (Anvisa);
- Therapeutic Goods Administration (TGA) of Australia;
- Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
What is assessed in an MDSAP audit?
Normally, the audits are divided into modules so that they address different aspects of regulatory compliance and quality, including:
- Record and Document Control: this module verifies how the manufacturer controls the creation, review, approval, distribution and archiving of documents and records related to quality and regulatory compliance. The goal is to ensure the integrity, traceability and availability of essential records.You might also like: Document management and training for the pharmaceutical industry: an essential combination
- Quality Management System (QMS): the manufacturer’s quality management system is assessed to ensure that processes and procedures are in compliance with regulatory requirements through the review of documents, records and policies related to quality management.
- Risk Management: this module focuses on analyzing the manufacturer’s ability to identify, assess and control risks associated with products. It reviews risk analysis processes, implementation of control measures and related documentation.
- Change Control: this module evaluates the manufacturer’s processes and procedures for managing and controlling changes in products, processes or systems. The goal is to ensure that changes are properly planned, implemented and validated, and that impacts on quality and regulatory compliance are effectively managed.
- Internal and Follow-up Audits: these are used to verify whether the manufacturer carries out regular internal audits to assess compliance and the effectiveness of the quality management system. It also assesses the corrective and preventive actions adopted as a result of these inspections.
For the inspection and certification of each module, manufacturers are audited using standard audit processes, containing the stages of preparation, scheduling, auditing, report of notes, corrective action plan, validation of actions and, finally, certification.
Cooperation models such as MDSAP are designed to facilitate processes and provide benefits for all parties involved. Below are some of the expected benefits for MDSAP member nations.
Program benefits:
- Regulatory harmonization: harmonization reduces the need for multiple and complex audits in different countries, facilitating access to international markets. This simplifies the process for manufacturers, who can comply with a common set of regulations and guidelines;
- Efficiency and cost reduction: regulatory authorities share information and conduct joint audits. This reduces the duplication of efforts and resources, making the process more efficient and cost-effective for all parties involved. Manufacturers benefit from passing a single audit recognized by different authorities, saving time and reducing the costs associated with individual audits in each country;
- Improvements in quality and safety: With the exchange of information and a uniform approach for assessing regulatory compliance and the quality of healthcare products, manufacturers are encouraged to adopt more robust quality practices and improve their quality management systems in order to satisfy program requirements;
- Facilitated international trade: the cooperation provided by MDSAP facilitates international trade in medical devices sector. With harmonized regulatory requirements and simplified audit processes, manufacturers can get easier access to different markets, expanding their business opportunities;
- Sharing knowledge and best practices: the sharing of knowledge and best practices among participating regulatory authorities contributes to the ongoing improvement of regulatory processes and quality policies.
Even though this is a cooperation program that seeks to standardize practices, it is important to note that the steps and the details of the process may vary a little depending on the country and the specific regulatory authority involved in the MDSAP.
Conclusion
As we have seen in this article, the Medical Device Single Audit Program (MDSAP) has proven to be a promising initiative in the medical devices sector, promoting homogeneity between nations, interaction between markets and contributing to products with improved quality and safety for users.
Investing in internal audits to verify regulatory compliance in your business can be a great way to improve your processes and prepare for a supervisory audit at the MDSAP level and beyond.
Check out the e-book “Audits for Pharmaceutical Manufacturers: 4 Key Steps for Reliable Results” that we have prepared to help you carry out inspections in the pharmaceutical sector.
