Changes in manufacturing processes, facility and/or Quality Management
System Examples


Category (Significant, non-significant)

Changes to QMS Certificate, such as:

  • Change/addition/removal of manufacturing site,
  • Change of scope

Change to manufacturing processes (including changes made to outsourced processes) that may affect the safety and/or performance of the medical device, such as:

  • Change in the equipment used for cutting, resulting in the change in length of sutures.
  • Moulding or cutting manufacturing process.
  • Change of centrifugation to filtration process which results in better molecule separation.
  • Change of implant manufacturing process from casting to 3D printing Change from manual operation to automatic operation, without changing the product specification.


Change in specification of registered medical device due to change in critical supplier, such as:

  • Change of the supplier of the Antibody with different manufacturing process.
  • Change of supplier of plastic raw material of catheter.

Changes to Manufacturing QC process issues, such as:

  • Removal of two test parameter and extend acceptance criteria .

Change of zip code on the certificate, typo errors and correction

Non - Significant
Changes to Manufacturing QC process, such as:

  • New QC specification with additional testing.
  • Change of measuring and/or monitoring equipment without changing test parameter.

Non - Significant
Change in non-critical supplier that extrudes the polymer tubing with no change in finished product performance specifications.

Non - Significant