15 categories of equipment reduced category, another 13 categories of catalog content adjustment

Medical Network January 6th, December 31st.
the State Drug Administration issued an announcement to adjust the contents of the Medical Device Classification Directory, which adjusts the contents of the Medical Device Classification Catalog for 28 categories of medical devices.
, adjust the content of 15 categories of medical device management categories to adjust.
for example: 13 types of medical device catalog content to adjust.
e.g., the implementation requirements (1) From the date of this announcement, the drug regulatory department shall accept applications for registration and filing of medical devices in accordance with the Measures for the Administration of Medical Device Registration, the Announcement on the Requirements for the Publication of Information on the Registration of Medical Devices and the Approval of Certificate Document Formats, and the Announcement on Matters Related to the Filing of Class I Medical Devices.
(2) For medical devices that have not yet completed the registration approval (including first registration and renewal registration), the drug regulatory department shall continue to review and approve the medical devices in accordance with the original acceptance category, grant the registration, issue the medical device registration certificate, and indicate the adjusted product management category in the registration certificate comments column.
(iii) For registered medical devices, the management category shall be adjusted from the third category to the second category, and the medical device registration certificate shall remain in effect for the period of validity.
If renewal is required, the registrar shall apply to the corresponding drug regulatory department for renewal of registration in accordance with the changed category six months before the expiration of the validity period of the medical device registration certificate, and if the renewal registration is granted, the medical device registration certificate shall be issued in accordance with the adjusted product management category.
for registered medical devices, the management category is adjusted from the second category to the first category, and the medical device registration certificate shall remain in effect for the duration of the validity period.
Before the expiration of the registration certificate, the registrant may apply to the corresponding drug regulatory department for product filing, and if the filing information meets the requirements, the drug regulatory department shall, in accordance with the relevant requirements, produce the filing certificate and publish the information in the filing information form on its website.
change of registration occurs within the validity period of the medical device registration certificate, the registrar shall apply to the original registration department for a change in registration.
if the original registration certificate is issued in accordance with the original Medical Device Classification Directory, the product management category after the implementation of the announcement shall be indicated in the comments column of the registration change documents of the products involved in this announcement.
(5) Drug supervision and administration departments at all levels should strengthen the training of the content adjustment of the Medical Device Classification Directory, and do a good job in the review, approval, filing and post-market supervision of relevant products.
this announcement shall be implemented from the date of publication.
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