What is MDSAP?
MDSAP (Medical Device Single Audit Program) is a regulatory program jointly implemented by multiple national authorities to audit the quality management systems of medical device manufacturers. Through a single audit, companies can meet the regulatory requirements of multiple countries simultaneously. It is considered one of the most rigorous and authoritative quality system certifications in the global medical device industry.
Participating Regulatory Authorities
The MDSAP program is jointly implemented by major health authorities, including the U.S. Food and Drug Administration (FDA), Health Canada, the Therapeutic Goods Administration (TGA) of Australia, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and Brazil’s National Health Surveillance Agency (ANVISA).
As such, obtaining MDSAP certification means that a manufacturer’s quality management system has successfully passed a comprehensive audit based on internationally recognized standards, demonstrating the company’s ability to comply with regulations in major global markets.
MDSAP and Menstrual Products
For menstrual cups and menstrual discs—recognized as medical devices in jurisdictions such as Canada and the United States—MDSAP certification represents the highest standard of regulatory compliance. Given their classification (often as Class II medical devices), these products are subject to stringent oversight requirements pertaining to safety, biocompatibility, sterilization, and quality system management. MDSAP certification provides critical regulatory assurance, demonstrating that a manufacturer meets the comprehensive quality and safety standards required for market access in highly regulated jurisdictions.
For example, in Canada, one of the MDSAP participating countries, MDSAP certification is a mandatory requirement for manufacturers of Class II, III, and IV medical devices seeking market authorization, underscoring the certification’s legal and operational significance.
(Source: Health Canada – MDSAP Transition Plan FAQ)
Broad Applicability Across All Device Classes
MDSAP is not limited to high-risk devices. Its scope encompasses a full range of product categories — from low- to high-risk — ensuring comprehensive oversight and consistent quality across all levels of medical device manufacturing. Manufacturers who attain this certification demonstrate their ability to meet some of the most rigorous quality and safety standards worldwide.
Our Commitment to Excellence
We are currently undergoing MDSAP certification as part of our ongoing commitment to world-class quality and regulatory excellence. This initiative reflects our ability to meet the most rigorous international standards and aligns with our strategic vision to serve global markets.
As a trusted manufacturer of sensitive medical products such as menstrual cups and menstrual discs, we understand the importance of safety, hygiene, and compliance. Achieving MDSAP certification strengthens our quality management system and empowers us to support our partners worldwide with confidence and consistency.
