In the corneal contact lenses fitting business should be set up in the reception room (area), examination room (area), optometry room (area) and fitting room; business premises using an area of not less than 50 square meters.
Medical device license to deal with what conditions are required⒈ "Medical Device Business License Application Form"; (with the National Bureau of application form to fill out the customer version of the program production); ⒉The applicant's qualifications (such as entrusted to another person, should be accompanied by the applicant's signed letter of attorney and the identity of the person entrusted with a photocopy of); ⑶ Business License or pre-approval of the business name of the file a photocopy of the certificate;⒋ Managers of the qualification certificate (medical devices, biomedical engineering, machinery, electronics, college or above, ID card, diploma or certificate of title) photocopies and biographical data; careful after-sales service personnel qualification certificate (medical devices, biomedical engineering, machinery, electronics, or related secondary school or above, ID card, diploma or certificate of title) photocopies and biographical data; select the registered address (business premises) and Photocopies of maps of the registered address (place of business) and the warehouse, floor plans indicating the area, and files of proof of ownership or use of the house; a declaration of authenticity of the declared materials; and a management system. Auqida consulting agency What information is required for a medical device license
Medical device business should have:
Personnel:
(a) the second / third class of medical devices business enterprise quality officer should have a medical device-related professions (related professions refer to the medical device, biomedical engineering, mechanical, electrical, medical, bioengineering, chemical, pharmaceutical, Nursing, rehabilitation, testing, computers, law, management, etc.) college degree or above, or intermediate or above professional and technical title, and should have more than 3 years of experience in quality management of medical device business;
(b) engaged in in vitro diagnostic reagents quality management personnel, there should be a supervisor of the examiner, or with a university degree in testing related disciplines and engaged in testing related work More than 3 years of work experience. In vitro diagnostic reagents acceptance and after-sales service personnel, should have a secondary school education in testing related disciplines or have a junior or above the professional and technical title of inspector;
(C) engaged in implantable and interventional medical devices business personnel should be equipped with college education in medicine-related disciplines, and through the production company or supplier training personnel;
(D) Engaged in corneal contact lenses, hearing aids and other medical equipment business personnel with special requirements, should be equipped with relevant professional or vocational qualifications;
(e) acceptance, after-sales service personnel should have a secondary school education in inspection; corporate custodianship, sales and other staff, should have a high school or junior college education.
Site: business, storage space (office area of more than 80 m?) (more than 60 m? of ordinary product warehouse);
Environment: the warehouse should be a cool warehouse, temperature and humidity control devices (such as air conditioning, etc.); business premises should be a product display cabinets; the operation of in vitro diagnostic reagents or the need for refrigeration of the product requires cold storage, cold cabinets, refrigerated transportation devices, etc.;
System
System: quality management system, professional guidance, technical training, after-sales service;
System: the operation of Class III medical device companies, should have a computerized information management system that meets the requirements of quality management of medical device business.
Engaged in two or three types of business need to submit the following information: (except for the second type of Article 8)
(a) business license and organization code photocopy of the certificate;
(b) legal representative, the person in charge of the enterprise, the person in charge of the quality of the identity of the person in charge of the replica of the certificate of qualifications or titles;
(c) organization and departmental setting description;
(D) business scope, mode of operation;
(E) business premises, warehouse address of the geographic location map, floor plan, or photocopy of the file of proof of property rights or lease agreement (with proof of property rights file);
(F) business facilities, equipment directory;
(VII) business quality management system, work programs and other files directory;
(H) Computer Information Management System (CIMS), the quality management system, the quality management system, the quality management system, the quality management system and other files directory;
(H) the basic information and functional description of the computer information management system;
(I) proof of authorization of the operator;
(J) other supporting materials.
for medical equipment business license what information is requiredmedical equipment two or three types of licenses required information: (good helper to provide)
1. Manufacturer of three photocopies of the certificate (stamped with a red seal)
2. photocopies of the annex to the certificate of registration of the product (stamped with a red seal)
3. photocopies of the production license (stamped with a red seal)
4. authorization for distribution ( Authorization letter (red seal, issued in the name of the company)
5. color scanned copies of the ID cards of two executives
6. resume of two executives
7. color photocopies of the graduation certificates of two executives with college education or above
8. photocopies of the ID cards of the warehouse keeper, the after-sales service personnel, and the finance personnel, as well as their cell phone numbers
Does the medical device business license need annual inspection?No annual inspection, but every year to fill in the self-inspection report
Must be an annual inspection, but the annual inspection of each place is different Some places are strict Some places sent to see the local food and drug supervision easy to see the situation
Medical device license changeWell, need to verify the acceptance of the site.
First, the license case:
"Medical Device Business License" case change
Second, the license is based on:
"Supervision and Administration of Medical Devices Regulations", "Supervision and Administration of Medical Devices Business", "supervision and management of single-use sterile medical devices (Interim)", "disposable use of sterile medical devices business enterprise", "implementation rules for the recognition of qualifications (Interim)", "the implementation rules for the recognition of qualifications (Interim)", "the implementation rules for the recognition of disposable use of sterile medical devices business enterprise". Qualification Accreditation Implementation Rules (Interim)", "local" supervision and management of medical devices business enterprise "implementation rules"
Third, the scope of acceptance:
change the enterprise name, registered address, business address, legal representative (responsible person), product range, etc.
Fourth, the declaration of information:
"local medical device business enterprise application form for changes
(a) on the change of matters relating to the approval of the higher authorities file or board of directors resolution or the need to invest in the corresponding file issued by the investor, etc.
(b) the relevant reporting materials
1, change of business name: a new business license or the administrative department of industry and commerce issued a photocopy of the "Notice of Approval of Change of Business Name".
2, change of address: proof of property rights or proof of property rights + photocopy of the lease contract, geographic location map and floor plan
3, change of product range: a) increase the range of products with the new start-ups; b) the operation of medical equipment varieties that require special management, in accordance with the relevant provisions of the application for processing (eg: the operation of single-use sterile medical devices need to comply with the National Bureau of Decree 24) (The requirements of the implementation of the rules).
V. Procedures:
Provincial acceptance - material review - on-site review (licensing matters according to the licensing standards entrusted to the municipal review) - Provincial Board Decide whether the license is granted to change
Six, the time limit:
Thirty working days
Seven, the acceptance of the location:
Provincial Food and Drug Administration administrative licensing for the Office
There is no clear regulation, this should be the local regulations.
"Supervision and management of medical equipment business approach" does not specify the time limit for change.
Potential therapeutic instrument does not belong to the state liberalization of the range of varieties, if the high-pressure potential therapeutic instrument or belong to the third class of medical devices, if you want to operate need to apply for a medical device license, as to how to apply, please consult the local drug supervision department.
Class II medical device license
First, the operation of the second class of medical devices do not need to apply for a license, only need to apply for the record certificate can be.
Second, for the specific process:
(a), the first to the Business Bureau for business license, registered as a business, can be a corporate enterprise, unincorporated businesses, sole proprietorships, partnerships, etc., individual businessmen and women are not allowed to apply for the record certificate.
(ii), and then to the Quality Supervision Bureau for the organization code certificate.
(c), and finally to the State Food and Drug Administration website with the organization code to register an account, online reporting.
(d), the online declaration of "medical device filing application form" need to submit electronic materials, which add * for the necessary items.
1.* photocopy of the business license and organizational code certificate
2. * legal representative, the person in charge of the enterprise, the person in charge of quality of the identification, education or title certificate replica
3. * organizational structure and departmental setting instructions
4. * business scope, business mode description
5. * business premises, warehouse Address of the geographic location of the map, floor plan, or photocopy of the file of proof of property rights or lease agreement (with proof of property rights file)
6.* business facilities, installations directory
7.* business quality management system, work programs and other files directory
8. computer information management system basic information and functional description
9.* operator Proof of authorization
10. * Signed and stamped scanned application form
Third, the second class of medical devices for the record, the approval department is the municipal level of the Drug Administration, the online reporting acceptance of the enterprise according to the requirements of the paper material to the hall of government to declare the acceptance of the site, after the issuance of the record voucher you can operate.