Drugdu.com expert's response:

The Medical Device Single Audit Program (MDSAP) audit process is a systematic and standardized procedure designed to ensure that medical device manufacturers' quality management systems comply with the regulatory requirements of various countries/regions participating in the MDSAP. Below is a detailed introduction to the MDSAP audit process and its contents:

I. Audit Process Preparation Stage

Understanding MDSAP Requirements: Firstly, enterprises need to thoroughly understand the MDSAP requirements, including the regulations, standards, and specific requirements of each participating country & region involved.

Internal Audit and Preparation: Enterprises must conduct an internal audit of their quality management system to ensure it has been established and maintained in compliance with MDSAP requirements. This includes preparing necessary documents and materials such as quality management manuals, procedure documents, and records.

Selecting an Audit Organization: MDSAP certification requires audits to be conducted by third-party audit organizations accredited by the International Medical Device Regulators Forum (IMDRF). Enterprises must select an audit organization with MDSAP certification qualifications and extensive experience, and sign a contract with them.

Submitting an Application: Enterprises submit MDSAP certification applications to the selected audit organization, providing necessary documents and information such as company basic information, product information, and quality management system documents.

Developing an Audit Plan: The audit organization and the enterprise jointly develop an audit plan, clarifying the audit time, location, audit team composition, and audit scope.

Document Review: The audit organization reviews the quality management system documents submitted by the manufacturer to assess whether the manufacturer has established a quality management system that meets MDSAP requirements and to determine preparedness for on-site audits at any key locations of the manufacturer.

On-Site Audit: The audit organization dispatches auditors to conduct an on-site audit at the enterprise. Auditors will inspect the enterprise's quality management system documents, technical documents, risk management files, and evaluate the implementation of the quality management system. Additionally, auditors will conduct interviews with enterprise employees to understand their understanding and practice of quality management.

Issuing Problems and Rectifications: During the audit, auditors may identify issues or nonconformities that do not meet MDSAP requirements. The enterprise will need to develop a Corrective and Preventive Action (CAPA) plan for these issues and submit it to the audit organization for evaluation.

Audit Report Generation and Certification Decision: After the audit, the audit organization will generate an audit report listing the identified issues, nonconformities, and the enterprise's CAPA plan. The audit organization evaluates the enterprise's CAPA plan and decides whether to grant MDSAP certification. If the enterprise's CAPA plan is accepted and all MDSAP requirements are met, the audit organization will issue an MDSAP certification certificate.

Surveillance Audit and Certificate Renewal: The validity period of MDSAP certification is typically three years, during which enterprises need to undergo regular surveillance audits to ensure ongoing compliance with MDSAP requirements. Before the certificate expires, enterprises need to apply for certificate renewal and undergo a re-audit by the audit organization.

II. Audit Content

The audit content of MDSAP primarily includes the following seven processes, which are audited based on risk management principles

Management: This involves the enterprise's quality policy, quality objectives, organizational structure, responsibilities and authorities, and internal communication.

Medical Device Marketing Authorization and Factory Registration: This includes procedures and requirements for obtaining product marketing authorization and factory registration.

Measurement, Analysis, and Improvement: This involves the collection, analysis, utilization of quality data, and measures for continuous improvement.

Medical Device Adverse Events and Advisory Notices: This includes the reporting, investigation, handling, and preventive measures for adverse events.

Design and Development: This involves product design input, design output, design verification, design validation, and design changes.

Production and Service Control: This includes control of the production process, product inspection and testing, control of nonconforming products, and after-sales service.

Procurement: This involves the procurement process for raw materials, components, and outsourcing services, as well as the selection and evaluation of suppliers.

In summary, the MDSAP audit process and content constitute a rigorous and systematic procedure aimed at ensuring that medical device manufacturers' quality management systems comply with the regulatory requirements of multiple countries & regions globally. By obtaining MDSAP certification, enterprises can more easily market their products in the markets of countries/regions participating in the MDSAP program.