2. Bring the original business license, ID card, proof that no illegal acts have been investigated, list of surplus commodities, and handling instructions.
3. For details, please consult the window staff of the local drug supervision department.
Changes in the business license of Class III medical devices; Procedures for changing the business license of Class III medical devices.
(1) application conditions
1. The medical device business enterprise applying for change has not been investigated by the drug supervision department;
2. The medical device business enterprise applying for change has been investigated by the drug supervision system, but the case has been closed; Or has fulfilled the punishment;
(2) Application materials (in duplicate)
1. Changes of licensed items:
(1) An application report on the change of medical device business license;
(2) Fill in a complete Application Form for License Change of Medical Device Business Enterprises;
(3) The original and photocopy of the License for Medical Device Enterprises;
(4) A copy of the business license stamped with the fresh seal of the enterprise;
5] Revised Pharmaceutical Trading License (submitted by pharmaceutical trading enterprises)
(6) Self-assurance statement on the authenticity of information (signed by the legal representative of the enterprise that has obtained the business license and stamped with the fresh seal of the enterprise);
(7) Proof materials of relevant changes:
◆ Change the person in charge of quality management organization or quality management personnel: submit the new person in charge of quality management organization or quality management personnel's ID card, copy of academic certificate or professional title certificate, resume and my full-time job commitment letter;
◆ Change the registered address or warehouse address of the enterprise: submit the property right certificate or a copy of the lease agreement of the change address, the geographical location map, the house plan, the description of the storage conditions, and the on-site inspection score table of the medical device business enterprises in Zhejiang Province (enterprise self-inspection score);
◆ Change the business scope: submit the catalogue of the products to be operated, the copy of the registration certificate of the products to be operated, the description of the corresponding storage conditions, the roster of enterprise personnel (corresponding positions should be defined), and the on-site inspection score table of medical device operating enterprises in Zhejiang Province (enterprise self-inspection score);
2. Change of registered items
(1) An application report on the change of medical device business license;
(2) Fill in a complete Application Form for License Change of Medical Device Business Enterprises;
(3) The original and photocopy of the License for Medical Device Enterprises;
(four) a copy of the changed business license with the new seal of the enterprise;
5] Revised Pharmaceutical Trading License (submitted by pharmaceutical trading enterprises)
(6) Self-assurance statement on the authenticity of information (signed by the legal representative of the enterprise that has obtained the business license and stamped with the fresh seal of the enterprise);
If the person in charge changes, a resume, a copy of ID card and relevant personnel appointment and removal files shall be attached; And the person in charge's diploma or title certificate copy, full-time job commitment letter.
(3) Procedures
The applicant shall submit the application materials to the provincial US Food and Drug Administration.
1. Changes of licensed items
(1) Application accepted. Medical device business enterprises will apply the application materials to the Municipal Bureau entrusted by the Provincial Bureau. According to the requirements of the Municipal Bureau of formal review of the application materials. If the application materials are complete and conform to the statutory form, or the applicant submits all the corrected application materials as required, the Municipal Bureau will review and report to the acceptance hall of the Provincial Bureau within 10 working days according to the On-site Inspection Scoring Form of Medical Device Enterprises in Zhejiang Province. The acceptance hall issued an acceptance notice. The acceptance notice shall be stamped with the special seal for acceptance and indicate the date of acceptance.
(2) Audit decision. The provincial bureau shall, within 10 working days from the date of accepting the application for the change of the licensing items of medical device enterprises, conduct an audit as required, and make a decision on whether to approve or not to change. After making the decision to approve the change, record the content and time of the change on the copy of the License for Medical Device Business Enterprise; If it does not change, it shall inform the applicant in writing and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.
After the medical device business enterprise changes the licensing items of the Medical Device Business License, it shall go through the relevant enterprise registration change procedures with the administrative department for industry and commerce according to law. After the change, the validity period of the medical device enterprise license remains unchanged.
2. Change of registered items
According to the Notice of Zhejiang Drug Administration on Implementing Simple Examination and Approval Procedures for Some Examination and Approval Items (Zhejiang Drug Administration Copy [2003] No.24), the simplified procedures were completed on the spot in the acceptance hall of the Provincial Bureau; If the change is approved, the contents and time of the change shall be recorded on the copy of the License for Medical Device Business Enterprises; After the change, the validity period of the medical device enterprise license remains unchanged.
Verb (abbreviation of verb) matters needing attention
(1) Where an enterprise is divided, merged or moved across the original jurisdiction, it shall cancel the original enterprise and reapply for the Medical Device Business License.
(2) The project change of Medical Device Business License can be divided into licensed project change and registered project change.
Change of licensing items: change of quality management personnel, registered address, business scope and warehouse address (including adding or deleting warehouses).
Change of registered items: change of enterprise name, legal representative and person in charge of the enterprise.
(3) Where a medical device trading enterprise changes the registered items of the License for Medical Device Trading Enterprise, it shall apply for the change within 30 days after the change is approved by the administrative department for industry and commerce.
(four) the change of the second kind of medical device enterprises shall be audited by the municipal bureau.
Can the third-class medical device business license be used across provinces? All provinces, autonomous regions and municipalities directly under the Central Government of the US Food and Drug Administration:
The Measures for the Supervision and Administration of Medical Device Production (Order No.7 of China Food and Drug Administration) and the Measures for the Supervision and Administration of Medical Device Operation (Order No.8 of China Food and Drug Administration) have been issued since 201410. The relevant matters are hereby notified as follows:
First, food and drug supervision and management departments at all levels should strengthen the publicity and training of the "Production Measures" and "Management Measures", deeply understand and master them, and conscientiously implement them in light of the actual work in their respective administrative regions.
Two, since 20 14, 10, 1, the production license and filing of newly established medical device manufacturing enterprises shall be handled in accordance with the relevant provisions of the Production Measures.
20 14+00+ 1 The license application for the newly established medical device manufacturing enterprise that has been accepted but not approved before shall be handled in accordance with the relevant provisions of the production measures after the implementation of the production measures.
Three, the existing "medical device manufacturing enterprise license" will continue to be valid within the validity period. After the implementation of the "Production Measures", if a medical device manufacturing enterprise applies for change, extension or replacement, it shall conduct an audit in accordance with the relevant requirements of the "Production Measures", conduct on-site verification when necessary, and issue a new "Medical Device Production License" if it meets the prescribed conditions. The validity period is calculated from the date of issuance.
If a class I medical device manufacturing enterprise has been registered, the manufacturing enterprise shall, before March 36, 2065 +0, handle a class I medical device production record with the local municipal food and drug supervision and administration department.
Four, the original has been registered for the second and third categories of medical devices commissioned production, after the implementation of the "Production Measures", when the license of the medical device manufacturing enterprise entrusted by any party expires or changes, continues or is renewed, the original commissioned production registration shall be terminated. If it is necessary to continue to entrust production, the entrusted production procedures shall be handled in accordance with the relevant provisions of the "Production Measures".
For those who have been registered to entrust the production of Class I medical devices, the registration of entrusted production will end on March 3, 20051. If it is necessary to continue to entrust production, the relevant procedures for entrusted production shall be handled in accordance with the relevant provisions of the Production Measures.
Five, medical device manufacturing enterprises "medical device manufacturing enterprise license" involves the establishment of production sites across provinces, can be produced until the validity of the "medical device manufacturing enterprise license". Where a production site established across provinces needs to continue production, it shall separately apply to the local provincial food and drug supervision and administration department for a production license in accordance with the relevant provisions of the Production Measures.
The "Registration Form of Medical Device Manufacturers of Class I" involves the establishment of production sites across cities divided into districts, which can be produced until March 3, 2065438. If the production sites set up in trans-regional cities need to continue production, they shall, in accordance with the relevant provisions of the production methods, handle the production record of Class I medical devices with the municipal food and drug supervision and administration department with districts.
Six, the export of medical devices manufacturing enterprises should export products related information to the local districts of the municipal food and drug supervision and management departments for the record. Relevant information includes export products, production enterprises, export enterprises, countries (regions) sold to, and whether overseas enterprises have commissioned production.
Seven, since 20 14, 10, 1, the new medical device business license and filing shall be handled in accordance with the relevant provisions of the administrative measures.
20 14+00+ 1 The application for the license of the newly established medical device business enterprise that has been accepted but not approved before shall be handled in accordance with the relevant provisions of the Business Measures after the implementation of the Business Measures.
Eight, the existing medical device business enterprise "medical device business enterprise license" will continue to be valid within the validity period. After the implementation of the Administrative Measures, if a medical device business enterprise applies for change, renewal or replacement, involving the operation of Class III medical devices, it shall conduct an audit in accordance with the relevant requirements of the Administrative Measures, conduct on-site verification when necessary, and issue a new Medical Device Business License if it meets the prescribed conditions, and the validity period shall be calculated from the date of issuance; Involving the operation of Class II medical devices, it shall be filed in accordance with the relevant requirements of the Operation Measures.
Nine, the "production measures", "management measures" and related forms involved in this notice are attached.
Ten, since the implementation of the "production measures" and "management measures", where inconsistent with the requirements of this notice, according to the requirements of this notice, the work should be timely feedback to the General Administration.
How long does it take to apply for the third class medical device business license? A: The Measures for the Supervision and Administration of Medical Device Operation clearly stipulates: 1, and it will take at most 5 working days to inform whether it is accepted or not; 2. Review within 30 working days at most after acceptance; 3. The certificate of conformity shall be issued within 10 working days at most. The specific provisions are as follows:
Article 9 The food and drug supervision and administration department at the municipal level divided into districts shall handle the application for business license of Class III medical devices submitted by the applicant according to the following circumstances:
(a) the application matters are within the scope of functions and powers of this organ, and if the application materials are complete and conform to the statutory form, it shall be accepted;
(2) If the application materials are incomplete or do not conform to the statutory form, the applicant shall be informed of all the contents that need to be corrected on the spot or within five working days. If the application materials are not informed within the time limit, it shall be accepted as of the date of receipt of the application materials;
(3) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot;
(four) the application matters do not belong to the scope of authority of the department, it shall immediately make a decision not to accept, and inform the applicant to apply to the relevant administrative departments.
If the municipal food and drug supervision and administration department with districts accepts or refuses to accept the application for medical device business license, it shall issue a notice of acceptance or rejection.
Article 10 The municipal food and drug supervision and administration department with districts shall, within 30 working days from the date of acceptance, review the application materials and conduct on-site verification in accordance with the requirements of the quality management standards for medical device operation. Need rectification, rectification time is not included in the audit time limit.
In line with the prescribed conditions, make a written decision to grant the license according to law, and issue the Medical Device Business License within 10 working days; Do not meet the prescribed conditions, make a written decision not to license, and explain the reasons.
Does Class III medical device business license include Class II? The business license for Class III medical devices does not include Class II medical devices; To operate Class II medical equipment, you need to apply for Class II business registration certificate.
Is it easy to apply for the license of three kinds of medical devices in Chengdu? It is better to ask someone for help, which is more efficient. Doing it by yourself is a bit troublesome and trivial. Find Sichuan to do business!
Please refer to the Measures for the Administration of Licenses for Medical Device Enterprises (DecreeNo.). 15) for how to apply for the license of three types of medical devices.
Article 12 An applicant shall apply to the (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the enterprise to be applied for is located or the (food) drug supervision and administration department of the city divided into districts entrusted by it for issuance of the Medical Device Business License.
For the applicant's "Medical Device Business License" application, the (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government or the entrusted (food) drug supervision and administration institution of the city with districts shall deal with it respectively according to the following circumstances:
(a) the application matters do not belong to the scope of authority of the department, it shall immediately make a decision not to accept, send a notice of rejection, and inform the applicant to apply to the relevant departments;
(2) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot;
(3) If the application materials are incomplete or do not conform to the statutory form, the applicant shall issue a Notice of Supplementary Materials on the spot or within five working days to inform all the contents that need to be supplemented at one time. Fails to inform, since the date of receipt of the application materials is accepted;
(4) Where the application matters fall within the authority of the department, the application materials are complete and conform to the statutory form, or the applicant submits all the corrected application materials as required, it shall issue a notice of acceptance. The acceptance notice shall be stamped with the special seal for acceptance and indicate the date of acceptance.
Article 13 The (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government or the entrusted (food) drug supervision and administration institutions of cities divided into districts shall conduct on-site verification of the enterprises to be applied for according to the acceptance standards of medical device trading enterprises, and review the application materials according to these Measures.
Fourteenth provinces, autonomous regions and municipalities directly under the central government (food) drug supervision and management departments shall make a decision on whether to issue the "medical device business license" within 30 working days from the date of acceptance. If it meets the requirements, it shall make a decision on granting the medical device business license, and issue the medical device business license to the applicant within 10 days from the date of making the decision. Do not meet the conditions, it shall notify the applicant in writing and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.
About how to apply for the second and third class medical device business licenses in Hangzhou, there is guidance from your local US Food and Drug Administration, or you can directly ask the municipal US Food and Drug Administration instead of the provincial US Food and Drug Administration. He also asked you to ask the city bureau, because the policies in different places are different, so I will use the process here in Changsha to tell you briefly, just for reference: first, determine your own business projects, because some products have different requirements for venues and majors, so you should prepare venues and majors according to the requirements of the Food and Drug Administration. Then rearrange the data, and after the leaders of the Municipal Bureau sign the words, send them to the Provincial Bureau. After the signing of the provincial bureau, there will be an on-site inspection to check your venue and personnel, and then publicize it online, and then get the certificate.
How to apply for the business license of Class II and III medical devices? For the specific process, please refer to the Measures for the Administration of Licenses of Medical Device Enterprises (Order No.2004). 15) was released on August 9, 2004.
How long does it take to apply for a Class III medical device business license? It depends on what your product is, whether clinical trials are needed, and whether your business license and business premises meet the requirements.