MDSAP is an acronym of Medical Device Single Audit Program. Medical device manufacturers who work globally and in different regions had to fulfill various regulatory obligations with respect to subscribed countries. Each regulatory body and enforcement agency had their own guidelines for auditing and inspection of manufacturer’s quality system and the manufacturing facility. Medical device manufacturers had to manage different regulatory inspection and audits based on the subscribed countries. For this very reason, IMDRF (International Medical Device Regulators Forum) proposed a pilot scheme in 2012 which is named as MDSAP to facilitate manufacturers by a single compliance audit rather than multiple audit schemes.
What is an MDSAP?
The Medical Device Single Audit Program is a harmonized way to auditing and inspecting the quality management systems of medical device manufacturing companies. It is a methodology in which companies (manufacturing medical devices) can be audited once for compliance with the regulatory and standard requirements of five different countries.
The Medical Device Single Audit Program permits a recognized Auditing Company to perform a single regulatory audit of a medical device manufacturer that conforms the relevant requirements of the regulatory authorities involved in the program. Since 2017, the implementation of this program is in effect.
What are the advantages of MDSAP certification?
The certification will help manufacturers in following ways:
- It minimizes the influx of regulatory inspections and audits, manufacturers have to undergo.
- Well-organized, single audit scheme reduces business interruptions; saves audit expenses and boost productivity time.
- It accelerates presence of companies in markets where regional regulatory oversight can consume substantial delays.
- This program increases the reliability of international regulatory programs by various participating and contributing regulators.
The Formulation of MDSAP
The first issue for manufacturers is to learn the formulation of this program. It is based on a logical process approach and is structured on the basis of ISO 13485 (the International standard for Quality management system of medical devices manufacturers and suppliers). Therefore; the auditing organizations have to follow the structured and logical approach during auditing as formulated by this program. It fundamentally utilizes the old ISO 13485:2003 as its framework, but, with the inception of ISO 13485:2016, the program is likely to adapt with the new standard. This MDSAP structure is divided in two sections, the first is primary and core processes, and the second is supporting and contributing processes. Overall it includes seven different processes:
Primary and core processes
- Management related processes
- Measurement, Analysis and Improvement
- Design and Development of Medical Devices
- Production and Service Controls
Supporting and contributing processes
- Purchasing and Procurement
- Medical Device Marketing Authorization and Facility Registration
- Medical Device Adverse Events and Advisory Notices Reporting
The Auditing Scheme
The audits under this program will be conducted once a year, incorporating a three-year certification cycle by recognized auditing organizations. Audit span will be calculated on tasks and not the head-count of that organization; audit reports must be provided to all regulators. There will be a database designed for the audit reports such that any contributing country can assess the reports that are related with a specific medical device manufacturer.
Regulators’ response on MDSAP
As per the Massachusetts Medical Device Industry Council, every participating country’s regulatory agency has got a scheme for implementation of this program:
• USA FDA will acknowledge MDSAP in place of routine inspections, but not for first visits or inspection based on a specific compliance issue.
• Health Canada will employ MDSAP to fulfill CMDCAS. The body has recognized the Medical Device Single Audit Program as a way to fulfill the quality management system requirements of the CMDR.
• The Brazilian National Health Surveillance Agency – ANVISA will acknowledge MDSAP for initial audits. This will also empower the regulatory body to cover-up the backlog of inspections, but the agency will still employ its auditors to perform ANVISA audits for higher-risk devices.
• Australian – TGA will utilize MDSAP to fulfill TGA requirements, accepting MDSAP certificates as the same as the CE certificates.
• Japan – MHLW will recognize MDSAP instead of a Japanese Quality Management System (J-QMS) audits (which are conducted on-site).
• Europe (EU) had only been an observer in the MDSAP pilot initiative, as there are some reservations that it would be challenging to have consent among all member states. However, the involvement of European notified bodies as an observer in this program narrates a durable association between EU and MDSAP. There is likely chance that EU will also adopt the program after some time, although MDSAP’s goal to harmonize quality system audits (eventually improving the safety and efficiency of medical devices) should help EU to enhance consistency across EU member states.
Preparing for MDSAP Audits with TS Quality
The regulatory requirements in various countries have not changed, but with the help of MDSAP; an integrated and logical audit approach is simplifying the complications of compliance. It will help companies to manage requirements of all MDSAP participating countries. MDSAP will also empower these organizations to intensively improve the Quality Management System (QMS). Some of the outcomes with the application of the MDSAP are compliance of multiple regulatory bodies with single audit, more powerful implementation of regulatory guidelines, improved global positioning, and even more. Let TS Quality International conduct a pre-audit review of your quality system to help your preparation for the authorized MDSAP audit. Contact us today and let our consultants evaluate your QMS and establish a practical plan that matches your specific needs.
