1, fill out the registration application form.
2, bring the original business license, bring the ID card, provide proof of no being investigated and dealt with illegal, the remaining list of goods and processing instructions and so on.
3, specific details of how to operate, please consult the local drug supervision department office window staff. Penalties;
(B) declaration materials (in duplicate)
1. Change of licensing matters:
(1) "Medical Device Business License" change application report;
(2) has filled out the "Medical Device Business License Change Application Form";
(3) "Medical Device Business License" copy of the original and photocopies
(4) photocopy of the Business License with the fresh seal of the enterprise;
(5) the changed Drug Operation License (submitted by the pharmaceutical enterprises)
(6) self-assurance of the authenticity of the information declared (signed by the legal representative, and stamped with the fresh seal of the enterprise for the enterprises that have already obtained the Business License);
(7) the relevant change of the content of the supporting materials:
◆ Change the quality management organization responsible person or quality management personnel: submit the new quality management organization responsible person or quality management personnel ID card, academic certificate or a photocopy of the certificate of title, personal resume and full-time full-time post of my commitment;
◆ Change the registered address or warehouse address: submit the change of address after the address of the property right certificate or photocopy of the lease agreement, geographic location map, house plan
◆ Change the scope of business: submit an application to increase the business product catalog, photocopy of the registration certificate of the product to be operated, the corresponding storage conditions of the description of the enterprise personnel roster (should be clear that the corresponding positions) and "Zhejiang Province, medical equipment business enterprise on-site inspection score sheet" (enterprise) Self-inspection scores);
2. Changes in registration
(1) "Medical Device Business License" change application report;
(2) has filled out the "Medical Device Business License Change Application Form";
(3) "Medical Device Business License" copy of the original and photocopies;
(4) stamped with the seal of the enterprise changed Photocopy of the Business License;
(5) The changed Drug Business License (submitted by the drug business enterprises)
(6) Self-assurance declaration of the authenticity of the information (signed by the legal representative and stamped with the fresh seal of the enterprise that has obtained the Business License);
(7) For the change of the person in charge, his/her resume, photocopy of the identity card and the relevant personnel appointment and dismissal files shall be attached; and Photocopy of the person in charge of the academic or professional title certificate, full-time and full-time post of my commitment.
(C) for the program
The applicant should be to the Provincial Food and Drug Administration and submit application materials.
1. Change of license matters
(1) application acceptance. Medical device business enterprises will apply for information to the provincial bureau entrusted by the municipal bureau to apply. Municipal Bureau shall be required to review the application materials form, application materials are complete, in accordance with the statutory form, or the applicant in accordance with the requirements to submit all the corrective application materials, the municipal bureau in 10 working days in accordance with the "Zhejiang Province, medical device business enterprises on-site inspection score sheet" for the audit reported to the provincial bureau of the acceptance of the hall. Acceptance of the hall issued by the "Notice of Acceptance". Acceptance Notice" should be stamped with the acceptance of the special seal and indicate the date of acceptance.
(2) audit decision. Provincial Bureau in the acceptance of medical device business license matters change application date within 10 working days of the requirements of the audit, to make the decision to grant changes or not allowed to change. Permitted to change the decision, in the "medical device business license" copy of the content and time to record the change; not allowed to change, inform the applicant in writing and explain the reasons, while informing the applicant to enjoy the right to apply for administrative reconsideration or administrative litigation according to law.
Medical device business enterprises to change the "medical device business license" after the licensing matters, should be in accordance with the law to the administrative department for industry and commerce for business registration of the relevant change procedures. After the change of the "medical device business license" validity period remains unchanged.
2. Changes in registration
According to "Zhejiang Provincial Drug Administration on the part of the approval of matters on the implementation of the simplified approval program notice" (浙药监办抄 [2003] No. 24), by the provincial bureau of the acceptance of the hall to simplify the program to be completed on the spot; allowed to change in the "Medical Device Business License" copy of the record of the change in the content and time; changes in the "Medical Device Business License" validity period of "Medical Device Business License". Medical Device Business License" validity period remains unchanged.
V. Precautions
(a) business separation, merger or migration across the original jurisdiction, should be registered out of the original enterprise, re-apply for the "Medical Device Business License".
(b) "Medical Device Business License" special case of change is divided into changes in licensing matters and changes in registration matters.
Changes in licensing matters: quality management personnel, registered address, business scope, warehouse address (including the increase or decrease of warehouse) changes.
Changes in registration matters: changes in the name of the enterprise, the legal representative, the person in charge of the enterprise.
(C) medical device business enterprises to change the "medical device business license" registration matters, should be approved by the administrative department for industry and commerce within 30 days after the change, the application for change.
(D) the second class of medical devices business enterprises to change, by the municipal bureau audit changes.
The third class of medical devices business license can be used across provinces
Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration:
"Supervision and Administration of Medical Devices Manufacturing Measures" (State Food and Drug Administration Decree No. 7) (hereinafter referred to as the "Production Measures") and "Supervision and Administration of Medical Devices Business Measures" (State Food and Drug Administration Decree No. 8) (hereinafter referred to as the "Operating Measures") have been released and implemented from October 1, 2014 onwards. The relevant matters are notified as follows:
First, the food and drug supervision and management departments at all levels should strengthen the "production methods", "business methods" of the publicity and training, deep understanding, proficiency, and combined with the work of the administrative region, and conscientiously implement.
Second, since October 1, 2014, the new start-up medical device manufacturers of production licensing, filing should be handled in accordance with the relevant provisions of the "production approach".
October 1, 2014 has been accepted but has not yet been approved by the new start-up medical device manufacturer license application, after the implementation of the "production methods" should be in accordance with the "production methods" of the relevant provisions of the process.
Third, the existing "medical device manufacturer license" in the validity period continue to be effective. After the implementation of the "production methods", for medical device manufacturers to apply for change, continuation, reissuance, should be in accordance with the "production methods" of the relevant requirements of the audit, on-site verification, if necessary, in line with the prescribed conditions, issued to the new "Medical Device Manufacturing License", the validity of the date from the date of issue.
Has been for the first class of medical devices manufacturer registration, the manufacturer should be in March 31, 2015 in accordance with the "production methods" of the relevant provisions of the municipal food and drug supervision and management department for the location of the first class of medical devices for the record.
Fourth, the original has been for the second, third class medical devices commissioned the production of registration filing, "production methods" after the implementation of the "production methods", commissioned by either side of the "Medical Device Manufacturer License" expiration or change, continuation, reissuance, the original commissioned the production of the registration filing should be terminated, the need to continue to commission the production of production, should be in accordance with the relevant provisions of the "Production Methods" commissioned to deal with the production formalities.
The original has been for the first class of medical devices commissioned the production of registration filing, its commissioned the production of registration filing to March 31, 2015 termination, the need to continue to commission the production, in accordance with the relevant provisions of the "production methods" for commissioned the production of relevant procedures.
Fifth, the medical device manufacturer's "medical device manufacturer's license" involves the establishment of production sites across the province, can be produced to the "medical device manufacturer's license" expiration date. Across the province to set up production sites need to continue to produce, should be in accordance with the "production methods" of the relevant provisions of the provincial food and drug supervision and management department separately to its location to apply for a production license.
Medical device manufacturers of "Class I Medical Device Manufacturer Registration Form" involves the establishment of production sites across the region of the city, the production can be produced until March 31, 2015 end. Across the city set up production sites need to continue to produce, should be in accordance with the "production methods" of the relevant provisions of the municipal food and drug supervision and management department separately to its location for the production of Class I medical devices for the record.
Six, the export of medical equipment manufacturers should be exported to the location of the municipal food and drug supervision and management department for the record. Relevant information, including export products, manufacturers, exporters, countries (regions) and whether the overseas enterprises commissioned the production of content.
VII, since October 1, 2014 onwards, the new start-up medical device business license, the record should be in accordance with the "business approach" for the relevant provisions.
October 1, 2014 has been accepted but not yet approved the new start-up medical device business license application, after the implementation of the "business approach" should be in accordance with the "business approach" relevant provisions.
Eight, the existing medical device business enterprise "medical device business enterprise license" in the validity period continue to be effective. After the implementation of the "business approach", for medical equipment business enterprises to apply for change, continuation, reissuance, involving the operation of Class III medical devices, should be in accordance with the "business approach" the relevant requirements of the audit, on-site verification, if necessary, in line with the prescribed conditions, issued to the new "medical device license", the validity of the date from the issuance of the license; involves the operation of Class II medical devices, should be in accordance with the "business approach" the relevant requirements of the filing.
IX, "production methods", "business methods" and the relevant forms involved in this notice are attached.
X. Since the date of implementation of the "production methods" and "business methods", where inconsistent with the requirements of this notice, according to the requirements of this notice, the work encountered related issues should be timely feedback to the General Administration.
How long does it take to apply for a Class III medical device license
A: "Supervision and Administration of Medical Devices" has express provisions: 1, up to 5 working days to inform whether the acceptance; 2 acceptance of up to 30 working days after the audit; 3 qualified up to 10 working days to issue a license. Specific provisions are as follows:
Article IX for the applicant to apply for a license for the operation of Class III medical devices, the municipal food and drug supervision and management departments should be based on the following circumstances were dealt with:
(a) the application belongs to the terms of reference of the application, application information is complete, in accordance with the statutory form, the application should be accepted;
(b) the application information is incomplete or does not meet the statutory form, the application should be accepted;
(c) the application information is incomplete or does not meet the statutory form. Or does not meet the statutory form, the applicant shall be informed on the spot or within five working days of all the contents of the need to make corrections, late notification, from the date of receipt of the application information shall be accepted;
(c) application information can be corrected on the spot errors, the applicant shall be allowed to correct on the spot;
(d) the application does not fall within the purview of the department, it should be Immediately make a decision of inadmissibility, and inform the applicant to the relevant administrative departments.
Municipal food and drug supervision and management departments in the district acceptance or inadmissibility of the application for a license to operate medical devices, shall issue a notice of acceptance or inadmissibility.
Article 10 municipal food and drug supervision and management department shall accept the date of 30 working days from the date of application for audit information, and in accordance with the requirements of the quality management standard for the operation of medical devices to carry out on-site verification. The need for rectification, rectification time is not counted in the audit time limit.
Meet the required conditions, according to law to make a written decision to grant permission, and within 10 working days to the "Medical Device License"; does not meet the required conditions, make a written decision not to permit, and explain the reasons.
Three types of medical equipment business license includes Class II
Three types of medical equipment business license does not include Class II medical devices; operation of Class II medical devices need to apply for Class II business filing vouchers.
Chengdu Class III medical device business license is good to do?
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How to apply for a Class III medical device licensePlease refer to the "Medical Device Business License Management Measures" (Bureau Decree No. 15)
Article 12 The applicant shall apply to the proposed business location of the provincial, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments, or to accept the entrusted municipal (food) drug supervision and management agencies, the district level "medical device business enterprise license" application. License" application for licensing.
For the applicant's "medical device business license" license application, the province, autonomous region, municipality directly under the central government (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies should be dealt with in accordance with the following:
(a) the application does not fall within the purview of the department, it should be made immediately inadmissible (A) the application does not fall within the purview of the department, shall immediately make a decision of inadmissibility, issued a "notice of inadmissibility", and inform the applicant to the relevant departments;
(B) the application materials can be corrected on the spot there are errors, the applicant shall be allowed to correct on the spot;
(C) the application materials are incomplete or do not meet the statutory form, shall be issued on the spot or within five working days to the applicant "Notice of Rectification", a one-off notice Need to make corrections to all the contents. Late notification, from the date of receipt of the application materials shall be accepted;
(d) the application falls within the purview of the department, the application materials are complete, meet the statutory form, or the applicant in accordance with the requirements to submit all the corrections to the application materials, issued a "Notice of Acceptance". Notice of acceptance" should be stamped with the acceptance of the special seal and indicate the date of acceptance.
Article XIII of the provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments or municipal (food) drug supervision and management agencies in accordance with the commissioned area based on the inspection and acceptance of medical equipment business enterprises to do on-site verification of the proposed business, and in accordance with these measures to review the application materials.
Article 14 Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments shall, within 30 working days from the date of acceptance, to make a decision on whether or not to issue a "medical device business license". Considered to meet the requirements, shall make a decision to grant the issuance of "medical device business license", and within 10 days of the date of the decision to the applicant to issue "medical device business license". Considered does not meet the requirements, the applicant shall be notified in writing, and explain the reasons, while informing the applicant of the right to apply for administrative reconsideration according to law or to bring an administrative lawsuit.
Hangzhou second and third class medical equipment business license how to apply forYour local Drug Administration has guidance, or you can go directly to the city Drug Administration to ask, do not go to the provincial Drug Administration to ask, asked him to ask you to go to the municipal bureau, because of the different policies of the various localities, I'll use the Changsha side of the program and you simply say it, only as a reference: first determine their own business case Because some products require different venues and specialties, so according to the requirements of the Food and Drug Administration to prepare venues and personnel, must look after the standard, otherwise it will not pass. Then compile the information, the municipal leadership after signing, sent to the provincial bureau, the provincial bureau after signing, there will be an on-site inspection, check your site and personnel, and then is the online publicity, and then take the certificate.
How to apply for a license to operate two or three types of medical devices. Specific process
"Medical Device Business License Management Measures" (Bureau Decree No. 15) August 09, 2004 Release
How long does it take to get a Class III medical device business licenseThis needs to depend on what your product is, whether you need clinical trials, your business license, and whether the place of business meets the requirements.