Incentive

In order to harmonize regulatory requirements in the field of medical devices on a global level, a cooperation between the regulatory authorities of Canada, USA, Brazil, Australia and Japan was established. With the Medical Device Single Audit Program (MDSAP), the regulatory requirements of the participating countries with regard to the quality management system can be examined in a single audit. These surveillance audits are recognised by the regulatory authorities, so that an additional examination by the participating authorities is not necessary in most cases. However, so-called «for-cause» audits or other case-related inspections cannot be replaced.

Outcome

Besides saving time by merging various inspections into one audit, manufacturers of medical devices benefit from simplified market access within the participating countries. For Canada, participation in the MDSAP is mandatory for the application for approval or extension of approval of medical devices.

Target groups

Distributors of medical devices and their critical suppliers who distribute the products in Canada, USA, Brazil, Australia or Japan.

Validity

3 years - there is an annual audit to ensure that standards are being maintained and a recertification audit after 3 years.

Recognition

The MDSAP audits are recognized by Canada, USA, Brazil, Australia and Japan. SQS participates in the MDSAP in cooperation with DQS. The certificates are issued by DQS.

Combinations

The MDSAP procedure can be combined with a certification according to ISO 13485:2016 and RL 93/42/EEC. The MDSAP certificate is issued by DQS, the certificates for ISO 13485 and RL 93/42/EWG by SQS.