We have been awarded certification for Quality Management System audit under the MDSAP
We are proud to announce that we have been awarded certification for the successful completion of a Quality Management System audit under the Medical Device Single Audit Program (MDSAP), expanding our global market access into Canada, Australia, Brazil, Japan, and the USA.
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.
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. 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).
Medical Device Single Audit Program (MDSAP) complies with the requirements of medical device auditing programs of five countries: Canada, Australia, Brazil, Japan, and the USA:
- Health Canada (HC)
- Therapeutic Goods Administration of Australia (TGA)
- Brazilian Agência Nacional de Vigilância Sanitária (ANVISA)
- Japan's Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA)
- United States Food and Drug Administration (FDA)
The MDSAP audit process covers all the requirements of:
- ISO 13485:2003 and ISO 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory purposes)
- Therapeutic Goods (Medical Devices) Regulations 2002
- Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013)
- Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169)
- Quality System Regulation (21 CFR Part 820)
Our design, development, production, and marketing activities have all been approved, and registration of our products and solutions will be possible in these countries through the MDSAP certification.
