Hello, according to the "supervision and management of medical equipment business approach" Article 4 of the operation of the second class of medical devices to implement record management. Shenzhen Class II medical device business filing process.
Longhua Class II medical device business filing department
When the municipal food and drug supervision and management department to the location of the district for the record.
Longhua Class II medical device business filing statutory time limit
Filing information is complete and meet the formal review requirements to be filed.
The second class of medical devices business filing on-site verification
Settlement of municipal food and drug supervision and management departments should be filed in the medical device business within three months from the date of business, in accordance with the requirements of the Code of Practice for the Quality Management of Medical Devices on the second class of medical devices business enterprises to carry out on-site verification.
Longhua Class II medical device business filing application material requirements
Longhua Class II medical device business filing notes
(1) For this matter, the filing application can be filled out online through the use of the "legal person a pass" online signature.
(2) chain stores retailing only 19 varieties, can be unified for the jurisdiction of the stores belonging to the second class filing, listed in the jurisdiction of the store list, the same material to provide a (exempt from repeated submission).
(3) According to the "Medical Device Classification Catalog" implementation, for the product category, scope of business, classification code this point must pay special attention. Especially in the period of alternation between the old and the new "Classification Catalog", the information on the registration certificate provided by the supplier may be the content of the old version of the Classification Catalog.
(4) The application materials should be complete, clear, accurate, alterations should be stamped or signed, required signature must be signed, stamped with the official seal of the enterprise, printed on A4 paper or photocopies, in accordance with the order of the application materials in a bound volume;
(5) Where the application materials need to be submitted to the applicant to submit a copy of the photocopy of the applicant must be signed to confirm that the photocopy (this piece of the same as the original), dated, stamped with the official seal of the enterprise;
(6) The declaration materials should be in Chinese, and the original text should be provided at the same time for the declaration materials translated from foreign language materials.