MDSAP and its implementation for Sanitary Registration of Medical Devices in Mexico with Equivalency Agreements
Since 2012 the International Medical Device Regulators Forum (IMDRF) has been working in a project called Medical Device Single Audit Program (MDSAP) with the aim of conducting a single regulatory audit of medical device manufacturers that satisfies the relevant requirements of the regulatory authorities participating in the program. The MDSAP must be performed by a recognized Auditing Organization (AO).
The MDSAP working group is formed by international partners divided into Members, Official Observers and Affiliate Members:
MDSAP Members
- Therapeutic Goods Administration of Australia (TGA)
- Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
- Health Canada (HC)
- Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency (MHLW & PMDA)
- U.S. Food and Drug Administration (FDA)
MDSAP Official Observers:
- The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme
- European Union (EU)
MDSAP Affiliate Members:
- Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT)
- Republic of Korea’s Ministry of Food and Drug Safety (MFDS)
On 2017, after 3 years the viability of the MDSAP pilot was confirmed by the MDSAP Final Pilot Report.
Since then, FDA continues accepting MDSAP audit reports as a substitute for routine Agency inspections (Establishment Inspections).
In 2019 Health Canada switched to MDSAP and SCC is no longer issuing accreditation to Authorized Registrar.
Even when MDSAP is currently focused on easily allow medical device manufacturers to market their products in the countries of MDSAP Members, it’s global approach makes it useful for obtaining marketing authorization in other countries such as Mexico by using the Equivalency Agreement .
Because the Equivalency Agreements in Mexico have not been updated for MDSAP purposes, COFEPRIS included it in a guide issued in 2020 for Good Manufacturing Practices and equivalent documents.
For medical devices already approved in the USA the following documents are considered as equivalent to the Establishment Inspection Report (EIR) for requests submitted through the FDA Equivalency Agreement:
- Medical devices Class I FDA: Last inspection report issued by MDSAP
- Medical devices Class II FDA with 510(k): ISO 13485 certificate (current version) issued by organism certified by MDSAP
On the other hand, the following documents are considered equivalent tothe Good Manufacturing Practices (GMP) for class II, III and IV products submitted through the Health Canada (HC) Equivalency Agreement path:
- ISO 13485 certificate (current version) issued by organism certified by MDSAP.
- ISO 17021 certificate issued by the same organism certified by MDSAP who issues the ISO 13485 certificate submitted.
- The organism (Registrar) issuing both certificates must be listed as certified by MSDAP
Recently, an announcement was made on July 7, 2023, regarding COFEPRIS criteria for the MDSAP results. According to this announcement, the MDSAP certificate will now officially be recognized as an equivalent to GMP for new registrations, renewals, and modifications of sanitary registries. This recognition applies to products manufactured both within and outside Mexican territory.
It is important to note that the validity and application of the contents of this announcement rely solely on COFEPRIS’ criteria. We will closely monitor any further developments related to this new announcement.
If you have any questions regarding MDSAP and its validity in Mexico to obtain Sanitary Registrations for Medical Devices using the fast track process known as Equivalency Agreements please contact us at contact@veraqueconsulting.com.
