If a manufacturer meets the conditions listed below, that manufacturer is eligible to be part of the PMAP. The manufacturer should:
- Meet both the US FDA and HC definition of a device manufacturer;
- Currently sell a Class II or III device in the US that meets the US definition of a medical device;
- Currently be in possession of at least one valid medical device licence to sell a Class II, III or IV device in Canada;
- Currently use the services of an AO that is both a Health Canada Recognized Registrar and a US FDA Accredited Person. (Note: FDA and HC will maintain a list of AOs that meet this criterion. This list will be posted on both Regulatory Authorities’ web sites.)
Manufacturers interested in participating in the pilot phase should send a letter to both FDA and HC noting their intent to participate in the PMAP and indicating how they meet the above eligibility criteria. Manufacturers can improve the multipurpose audit/inspection process by providing written consent for the sharing of pre-audit/inspection and post-audit/inspection information between FDA and HC. An example of a voluntary information release letter is included in Annex A of this document.
Sites that an AO would visit during a multipurpose audit/inspection would include, but are not limited to, sites in North America and overseas where:
- Overall management of the organization takes place;
- Products are designed;
- Assembly takes place;
- Products are packaged and stored;
- Contract sterilization takes place;
- Outsourced processes related to the device are performed by suppliers to the manufacturer;
- Device related complaints and problems are received and reported on; and
- Device related regulatory affairs are performed.
