In "Notice: Medical Device Single Audit Program (MDSAP) Transition Plan – Frequently Asked Questions (FAQ)",
Health Canada said
"Licences not supported by a valid MDSAP certificate as of January 1, 2019, will be subject to suspension. Holding a valid quality systems certificate is a regulatory requirement for a manufacturer to have an active medical device licence. All device licence applications and F202 notifications received after January 1, 2019, must contain a MDSAP certificate; a manufacturer’s CMDCAS certificate will not be accepted. "
ISO 13485:2003 will be replaced by ISO 13485:2016.
Can anyone tell which version of ISO 13485 is applied for MDSAP certificate?
Health Canada said
"Licences not supported by a valid MDSAP certificate as of January 1, 2019, will be subject to suspension. Holding a valid quality systems certificate is a regulatory requirement for a manufacturer to have an active medical device licence. All device licence applications and F202 notifications received after January 1, 2019, must contain a MDSAP certificate; a manufacturer’s CMDCAS certificate will not be accepted. "
ISO 13485:2003 will be replaced by ISO 13485:2016.
Can anyone tell which version of ISO 13485 is applied for MDSAP certificate?