Class II medical device business filing office guide
One, the project name
Class II medical device business filing
Two Acceptance of the organization
1, Jiangmen Food and Drug Administration is responsible for the city's medical equipment wholesale enterprises for the record, temporarily responsible for the Jiangmen City District (Pengjiang District, Jianghai District), the record of medical equipment retail stores (after the completion of the institutional reform of the two districts to the government for the record);
2, the cities (districts) is responsible for the jurisdiction of the Bureau of the record of the retail stores of medical equipment.
Third, the basis for processing
1, "supervision and management of medical devices regulations" (State Council Decree No. 650)
2, "on the production and operation of medical devices for the record on matters related to the announcement" (No. 25 of 2014)
Fourth, the conditions for processing
1, in line with the "supervision and management of medical devices regulations" (State Council Decree No. 650) relevant requirements;
2, the city (district) bureau is responsible for the filing of retail stores under their jurisdiction. No. 650);
2, in line with the "Measures for the Administration of Medical Device Business License" related requirements;
3, in line with the "In Vitro Diagnostic Reagent Business Enterprises (Wholesale) Acceptance Standards" related requirements.
V. The following materials should be submitted
1. Class II medical device business filing form;
2. A copy of the "industrial and commercial business license" issued by the administration for industry and commerce.
3. Legal representative or person in charge of the enterprise, the person in charge of quality, identity, education, title certificates;
4. Organization and departmental setup of the enterprise description;
5. Business address, warehouse address of the geographic location of the map, the floor plan (indicating the actual area of use), the documents of property rights of the building or lease agreement (with documents proving ownership of the building ) copies;
6. business facilities and equipment directory;
7. business quality management system, work procedures and other documents directory;
8. proof of authorization by the operator;
9. other supporting materials.
Filing materials in duplicate, should be complete, clear, printed and bound using A4 paper with a table of contents, copies stamped with an official seal and submitted together with the electronic version (electronic version sent to e-mail: jmylqxba@163.com).
Six, acceptance time
Working time: Monday to Friday 8:30 am-12:00 pm, 14:30 pm-17:30
Acceptance of the place:
Jiangmen Food and Drug Administration Government Affairs Window
Jiangmen City, Dixi East Road No. 88 (side of Renren Shopping Mall), Jiangmen Municipal People's Government Administrative Service Center, fourth floor, Area B, 46-49, 107 window.
seven, contact number
0750-3871081, 3871082
Complaints Tel: 0750-3281903 (Jiangmen Food and Drug Administration Supervision Office)
eight, the record procedures:
Municipal Administration General Food and Drug Administration Window to submit materials -→ (materials complete) acceptance -→ form of review -→ issued on the spot for the record vouchers
nine, the time limit:
eligible for settlement on the spot.
Xi, registration documents and validity: the record voucher, no expiration date.
xii, registration fees: no
Remarks:
Remarks 1: the operation of the "on the publication of the first batch do not need to apply for a "medical device business license" of the second class of medical devices product list notice" (State Food and Drug Administration City [2005] 239) and "on the publication of the second batch do not need to apply for a "medical device business license" of the second class of medical devices product list notice" (State Food and Drug Administration City [2005] 239) and "on the publication of the second batch do not need to apply for a "medical device business license" of the second class of Medical Device Product List Notice" (State Food and Drug Administration City [2011] No. 462) catalog of medical devices in the business enterprise shall apply for the record.
Remarks 2: has obtained the "Class II medical device business filing certificate" of the enterprise name, legal person, business address, business scope of change should be required to re-apply for the record in a timely manner;
Remarks 3: business enterprises to submit the "Class II medical device business filing application form" should be signed by the legal representative or stamped with the official seal of the enterprise (if any);
Remarks 4 : The items filled out in the "Application Form for Filing of Class II Medical Device Business" should be filled out completely and accurately, and the content of the filling should meet the following requirements.
A, "business name", " residence "" business premises "," depot address ", " Legal representative ", " responsible person " and " business license " or " pre-approved notice of enterprise name " the same.
B, to apply for the business scope of the State Drug Administration in 2002 issued by the "Classification of Medical Devices Catalog" a directory to fill out.
C, "registered address", "warehouse address" should be filled in specific door, floor and room number.
Remarks 5: Proof of property, proof of housing lease (site to provide proof of property rights) should be valid;
Remarks 6: legal representative, the person in charge of the enterprise, the quality of the manager's curriculum vitae, proof of academic qualifications or title should be valid;
Remarks 7: The enterprise should be the establishment of the quality of medical equipment management files or forms.
Remarks 8: Where the application materials need to submit a copy, the applicant (unit) shall indicate on the copy of the words "this copy is consistent with the original" or text description, indicate the date, stamped with the official seal of the unit; personal application shall be signed or stamped.
Remark 9: The application materials should be complete, clear, signed and stamped one by one; all application forms should be filled out by typing on computer, printed on A4 paper, copied on A4 paper, and bound according to the order of the catalog of application materials.
Remarks 10: According to the "State Council on the third batch of decisions to cancel and adjust the administrative approval projects" (Guo Fa [2004] No. 16), the cancellation of the domestic first-class medical device business enterprises for the record.
Remark 11: The original has obtained "Medical Device Business Enterprise License" and the business scope contains the second class of enterprises in the change or renewal of the license, to apply for the second class of medical equipment business record.
Download:
1.Announcement on Matters Relating to the Record of Medical Device Manufacturing and Operation (No. 25 of 2014).doc
2.Class II Medical Devices Business Record Form.doc
3.Class II Medical Devices Business Record Changing Form.doc
4.Class II Medical Devices Business Record Voucher.doc
5.Class II medical device business filing voucher replacement table.doc