Israel MDSAP Affiliate Membership
Medical Device Single Audit Program (MDSAP) is a recognized global approach by the International Medical Device Regulators Forum (IMDRF) to allow competent auditors from MDSAP recognized Auditing Organizations to conduct audit of a medical device organization’s quality management system (QMS) that will satisfy the requirements of the medical device Regulatory Authorities participating in the MDSAP program.
The participating MDSAP jurisdictions intend to promote a single program of audits that takes into account all of their requirements for QMS.
MDSAP Members that are participating in the MDSAP include the Therapeutic Goods Administration of Australia, the Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, the Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency and the U.S. Food and Drug Administration.
Moreover, international partners participating in the MDSAP also include Affiliate Members and, among them since 2022, the Ministry of Health of Israel.
An Affiliate Member demonstrates understanding of MDSAP and may utilize MDSAP audit reports and MDSAP certificates for evaluating a medical device manufacturer’s QMS.
Benefits for Affiliate Membership cover the following:
- Training on MDSAP
- Ability to utilize MDSAP reports in jurisdiction
- Receive MDSAP audit/site information (MDSAP Affiliate Report)
- Listed on MDSAP website as an Affiliate Member
- Participate in yearly MDSAP Forum meetings
Are you aware that Manufacturers of medical devices gain access to the Israeli medical device market by registering their device with AMAR, the Israeli Ministry of Health’s medical device regulation unit?
Medical device registration in Israel is based having prior approval in one of the five founding Global Harmonization Task Force (GHTF) countries: Australia, Canada, Europe, Japan, or the United States. Manufacturers that have already obtained approval for their devices in those markets can leverage those registrations to satisfy most of Israel’s medical device regulatory approval requirements: required documents for medical device registration in Israel include proof of Quality Management System certification.
If your company is an Isreali one aiming to place its medical device products in the Israeli market and also in, at least, one MDSAP participating jurisdictions, it might be a sensible and efficient regulatory strategy to achieve both aforementioned goals by planning to obtain the MDSAP certification.
PQE Group can help your organization to achieve such certification by providing tailored training, conducting customized gap analysis and supporting you in drawing up remediation plans to identify all necessary activities to meet MDSAP requirements.
Don’t wait, the time will never be just right!