Device registration renewal and change submission in China

When is the medical device registration renewal necessary?

The Chinese registration certificate is valid for 5 years. It is very important for manufacturer to remember that the submission deadline for the renewal is 6 months ahead of certificate expiring date. 

The manufacturers shall keep in mind that the NMPA regulatory requirements are updated frequently and continuously. Often, the registration renewal requires additional testing or clinical evaluation data because the relevant standards or guidelines are update within the last 5 years.  In case that additional testing or data are required, the renewal preparation process shall be planned 1.5 years ahead of the certificate expiring date. 

 

What are the working processes of certificate renewal?

As mentioned in the last session, the registration renewal usually accompanies the registration change, either because of the update of the product itself or the update of the relevant regulations, standards or guidelines. 

Three processes may be involved for submission with separate set of dossier:

  1. Registration renewal
  2.  Registration change of the registering items (“minor change”)
  3. Registration change of the item requiring approval (“major change”)

The “minor changes” refer to the contact information change of overseas MAH and the China agent, which does not affect the product itself. The change process does not require a technical review of the product.

The “major changes” refer to the product technical changes and the manufacturing site change. Any product information listed on the certificate, including the product name, model, configurations, components and composition, intended use and technical specifications, etc. requires further technical review of the product dossier. The same review process also applies when the relevant standards, guidelines, and other regulations are updated during the last 5 years.

The registration renewal shall submit the following dossier:

  1. Application form
  2. Business license
  3. Declaration of product no change
  4. Original product certificate and attachments
  5. product analysis report
  6. Product testing report, if necessary
  7. Declaration of conformity

The dossier for registration changes shall be submitted in a set separate from the registration renewal. The dossier content varies according to the actual changes. Please consult JMEDTEC for details via info@jmedtec.com.

For “minor changes” which does not require a technical review of the product, the NMPA administrative office is able to approve the change within 10 working days.

For “major changes”, the technical review takes 60 working days for class II and 90 working days for class III devices. The reviewer would then give a deficiency letter to the applicant. After giving the feedback to the deficiency letter, the reviewer shall take another 20 working days for the final approval. The certificate will be then issued in 10 working days after the approval. 

For renewal without any changes, the official technical review would take the same time as the “major change”. In reality, if no change was claimed, shorter processing time can be expected. 

Why choose JMEDTEC to assist the registration renewal and change?

JMedTec has a professional RA team with 10-20 year industry experiences. We are able to identify the optimized working plan and complete your renewal project to meet all the deadlines. 

Please contact us via info@jmedtec.com.