Currently, medical device companies must re-register within six months of the expiration of the original product’s registration certificate. Re-registration requires submitting substantial documentation, much of which is duplicate documentation from the original registration.
The CFDA has issued a new draft proposal that seeks to simplify the re-registration process by reducing the number of documents required in the product dossier. The new process would not require the submission of technical documentation if there have been no changes that would impact the safety or efficacy of the product. If changes were made, technical documents would only be required on those changes. The company would not need to include unchanged product standards, the testing report for registration, or the product manual.