How to Apply for Re-issuance of Your Lost Medical Device Registration Certificate in China

Medical device registration certificate is the identity card of product that indicates it can be sold in China. If the certificate is lost or corrupted within the effective period, you shall apply for re-issuance of medical device registration certificate.

How to get the new medical device registration certificate issued by CFDA? Applicant shall do it according to the revised procedures of Notification of Exposure Drafts about Related Working Procedures for Registration of Medical Devices.

1. Lost declaration

At first, applicant shall declare the invalid in the newspapers and periodicals designated by CFDA (If no special requirements, the newspapers and periodicals shall be the publication above provincial level.). The time of publication shall be 1 month prior to apply for replacement.

2. Dossier preparation

Prepare relevant documents. As following:
(1) Application form, which shall be sealed and signed by agent. All the content of application form shall be consistent with approved registration certificate, such as product name, manufacturer, packing specifications and so on.
(2) Reason and statement, include the cause of loss or damage, register situation (such as Certificate No, expires, product category, etc.). The files shall be signed by original legal person and sealed, then notarized by local notary organization.
(3) Original copy and copy of newspapers and periodicals, which shall be signed by original legal person and sealed, then notarized by local notary organization.
(4) Original copy or notarized copy of qualifications of register, such as Business License, Manufacturing License, etc.
(5) Power of attorney of agent. The POA which include those contents such as re-issue information, product name, certificate No. etc. shall be original copy and signed by original legal person and sealed, then notarized by local notary organization.
(6) Copy of registration certificate and its attachment or original No. of original certificate, which shall be sealed and signed by agent.
(7) Business License Copy and letter of commitment of agent, which shall be sealed and signed by agent.
(8) Declaration of conformity of register, include the list of documents and the acceptance to bear legal liabilities, which shall be signed by original legal person and sealed, then notarized by local notary organization.
(9) Power of attorney and Copy of ID card of conductor

3. Submission and approval

You can submit the dossier to CFDA after 1 month of Lost declaration publication. CFDA will review your application and give you comment within 20 working days.

4. Issue new certificate

Once the application is approved, you will get the new certificate. The re-issued certificate will use the original No. and the end will add “补” in bracket.

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