Once registrations for placing medical devices on the market in countries outside the European Union have been obtained, the competent authorities may audit the organisation in accordance with the quality management requirements of each country.
With the new MDSAP (Medical Device Simple Audit Program) currently recognized by the USA, Canada, Brazil, Australia and Japan, the organization will be able to certify its quality management system according to MDSAP, so that with a single audit it will achieve compliance for the countries under the program where it is marketing its products, thus saving the audits of each of the countries. These are:
- Australia's Therapeutic Goods Administration (TGA).
- Brazil's National Health Surveillance Agency (ANVlSA).
- Japan's Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA).
- Health Canada (HC).
- United States Food and Drug Administration (FDA).
In Azierta we can help you in updating the quality management system documentation to include the MDSAP requirements for the countries you need, as well as GAP audits and MDSAP analysis.