Notice of the State Food and Drug Administration on Requirements for Registration-related Work Following the Adjustment of Medical Device Classification

To the Food and Drug Administration (Drug Administration) of each province, autonomous region, and directly administered municipality:
To further standardize the registration management of medical devices, in accordance with the Measures for the Registration Management of Medical Devices and the Notice on Issuing the Provisional Regulations for Further Strengthening and Standardizing the Registration Management of Medical Devices (Guo Shi Yao Jian Xie [2008] No. 409), as well as other relevant provisions, the following requirements for the implementation of related registration procedures following the adjustment of medical device classification are hereby notified:
1. The management category has been adjusted from a higher category to a lower category.
(1) For medical devices that have already been approved for registration, if there are no other changes to the product during the validity period of the medical device registration certificate, the re-registration procedures shall be carried out in accordance with Article 6 of Document No. 409 [2008] issued by the State Food and Drug Administration. The medical device registration certificate remains valid throughout its period of validity. Prior to the expiration of the registration certificate, the manufacturing enterprise shall, in accordance with the revised classification, apply to the relevant food and drug regulatory authority for re-registration.
For products that, during their period of validity, undergo changes as specified in Articles 34 and 38 of the Measures for the Registration Administration of Medical Devices, or experience label‑related changes as stipulated in Article 19 of the Regulations on the Management of Instructions, Labels, and Packaging Markings for Medical Devices, the manufacturer shall submit an application to the relevant food and drug regulatory authority in accordance with the product’s revised classification.
(2) Effective from the date of the adjustment to the product’s regulatory classification, the original reviewing authority shall no longer accept applications for re‑registration. For applications that have already been accepted but for which a review decision has not yet been rendered, the original accepting authority shall continue to conduct technical evaluation and administrative approval in accordance with applicable laws and regulations; if registration is approved, the medical device registration certificate shall be issued under the original regulatory classification.
II. The management category is adjusted from a lower category to a higher category.
(1) For medical devices that have already been approved for registration, the manufacturing enterprise shall apply for a change and re‑registration in accordance with Article 35 of the Measures for the Administration of Medical Device Registration. Where an application for such a change and re‑registration is submitted as required, the original registration certificate shall remain valid within its period of validity until a decision on the re‑registration approval is rendered. If the re‑registration is not applied for within six months as prescribed, the original registration certificate may no longer be used.
(2) From the date of the adjustment to the product’s regulatory classification, the original reviewing authority shall no longer accept applications for re‑registration. For applications that have been accepted but for which a review decision has not yet been rendered, unless otherwise specified by the National Medical Products Administration, the original accepting authority shall conduct technical evaluation and administrative approval in accordance with the applicable regulatory requirements; if registration is approved, the medical device registration certificate shall be issued under the original regulatory classification. Within six months of obtaining the registration certificate, the applicant shall submit an application for amendment and re‑registration to the relevant food and drug regulatory authority corresponding to the revised classification.
(3) In the event that a product, during its period of validity, undergoes any changes as specified in Article 38 of the Measures for the Registration Administration of Medical Devices, or any changes to its instructions as stipulated in Article 19 of the Regulations on the Management of Instructions, Labels, and Packaging Markings for Medical Devices, the manufacturer shall submit an application to the relevant food and drug regulatory authority in accordance with the adjusted classification.
III. Documentation Requirements for Filing Relevant Registration Applications Following the Adjustment of Management Categories
In addition to submitting the application materials in accordance with relevant regulations, manufacturers shall also submit the package insert, standards, and other documents approved at the time of original registration. Furthermore, they must provide a self‑certification attesting to the authenticity of the submitted materials, ensuring that such materials are identical to those reviewed and approved during the original registration process. When necessary, the food and drug regulatory authorities may verify the authenticity of the submitted documentation. For products whose regulatory classification has been upgraded, the authorities may, based on the requirements of systematic evaluation, request the manufacturer to supplement clinical trial data or post‑marketing clinical evaluation data related to the product.
IV. Products No Longer Subject to Medical Device Regulation
The food and drug regulatory authorities shall no longer accept registration applications from such entities. For applications that have been accepted but not yet approved, the authorities shall, in accordance with applicable regulations, refuse to grant registration and shall file the relevant application materials. Medical device registration certificates that are still valid shall not be used thereafter.
State Food and Drug Administration
February 29, 2012