Medical Device Single Audit Program (MDSAP)

MDSAP & iMRS

From 2022, both iMRS Prime and Omnium1 are consider certified under MDSAP audit program. There are few key points distributors need to know:

1. MDSAP replaces all other certifications that iMRS had prior 2021.
2. MDSAP is an audit certification – meaning it certifies stringent processes needed for a medical device, not medical application. Having MDSAP doesn’t mean it’s medically approved for “treating” specific condition.
3. Having MDSAP doesn’t mean it’s automatically qualified for all participating regulators. The company will still need to apply for approval to the respective agencies. With MDSAP, it just means now it becomes a lot easier and faster. Always check with the company on the latest status of approval.
4. With MDSAP, all support and issues reporting will become more c

About MDSAP

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.

Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP requirements. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP). In 2014, the International Medical Device Regulators Forum (IMDRF) launched the Medical Device Single Audit Program (MDSAP) pilot. As of 2017, the MDSAP is in full force and fully operational.

The Structure

The first part to know is the structure of the MDSAP. Auditors will follow a structured and logical process approach when auditing. The program essentially uses the ISO 13485:2003 as a framework, however, with the introduction of ISO 13485:2016, the MDSAP will likely support the new standard. This model includes seven processes as followed:

Primary processes:

1. Management
2. Measurement, Analysis, and Improvement
3. Design and Development
4. Production and Service Controls

Supporting processes:

1. Purchasing
2. Device Marketing Authorization and Facility Registration
3. Medical Device Events and Advisory Notices Reporting

The audits will be conducted annually, encompassing a three-year certification cycle by approved auditing organizations.

MDSAP Members & participating groups

International partners that are participating in the MDSAP include:

• MDSAP Members
  • Therapeutic Goods Administration (TGA) of Australia
  • Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
  • Health Canada
  • Japan’s Ministry of Health, Labour and Welfare (MHLW), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)
  • U.S. Food and Drug Administration (FDA)

• MDSAP Official Observers:
  • European Union (EU)
  • United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)
  • The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme

• MDSAP Affiliate Members: (New)
  • Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT)
  • Republic of Korea’s Ministry of Food and Drug Safety
  • Singapore’s Health Sciences Authority (HSA)

MDSAP Certification

ISO 13485 Certificate