MDSAP Membership Types

In 2023, the Regulatory Authority Council (RAC) formalised its processes and requirements for MDSAP membership. Full information on MDSAP membership requirements is available in the MDSAP Roles and Responsibilities procedure. 

MDSAP has three types of membership:  

  1. RAC Member 
  2. Official Observer 
  3. Affiliate Member 

With the exception of the WHO, all member types must be a regulatory authority. A RA is a government body or other entity that exercises a legal right to control the use or sale of medical devices within its jurisdiction, and that may take enforcement action to ensure that medical products marketed within its jurisdiction comply with legal requirements. 

All membership types must be approved by the unanimous consent of the MDSAP RAC. Members must demonstrate a commitment to the objectives of MDSAP, through use of MDSAP within their regulatory framework.  

When you have determined which membership type suits your RA, please click here to apply online.

For contact details for the MDSAP RAC Secretariat and other MDSAP RAs, please click here. 

RAC Member

The RAC is the decision-making body of MDSAP and consists of senior-level managers from MDSAP member countries.

Official Observer

Except for the WHO, an MDSAP Official Observer is a RA which contributes to RAC activities or observes the operations of the program without being a formal member.

Affiliate Member

Affiliate Members are RAs that engage in MDSAP, demonstrate understanding of MDSAP and utilize MDSAP audit reports and MDSAP certificates for evaluating compliance with applicable medical device requirements.