How to apply for a Class I, II, or III medical device license? What are the requirements?
Answer: There is no need to apply for a license to operate Class I medical devices, as long as you have industrial and commercial registration.
Operating Class II medical devices requires the municipal bureau to register and issue a registration certificate.
Operating Class III medical devices requires permission from the Municipal Bureau and issuance of a license.
Starting from October 1, 2014, the "Medical Device Business License" must be applied for online and passed after on-site assessment.
You can click on the "Medical Device Production and Operation License Registration Information System" in the "Online Services" column on the homepage of the Food and Drug Administration website.
After entering the login page, there is a special operation manual and tutorial video download interface, which can be downloaded and used by the applicant company.
When applying for licensing and filing matters, in addition to completing the online declaration in the system, paper materials should also be submitted to the corresponding approval and filing departments before processing.
Note: 1. If the business license is not an enterprise, but an individual industrial and commercial household, it is not allowed to apply for a medical device business license.
(Individual) business licenses can be upgraded to the Industrial and Commercial Bureau. The specific steps are: first go to the industrial and commercial office of the Industrial and Commercial Bureau to register and fill in the form, then take the relevant materials to the government affairs hall to upgrade your business license to an enterprise, then apply for the organizational code certificate, and then declare online.
2. Electronic materials that need to be submitted in the "Medical Device Registration Application Form", among which items marked with * are required.
Electronic material upload only supports the upload of materials in image and pdf formats.
1. *Copy of business license and organization code certificate
2. *Copy of identity certificate, academic qualifications or professional title certificate of the legal representative, person in charge of the company, and quality director Printed copy
3. *Description of organizational structure and department settings
4. *Description of business scope and business methods
5. *Business location and warehouse address A copy of the geographical location map, floor plan, property ownership certificate file or lease agreement (with property ownership certificate file attached)
6.* Catalog of operating facilities and equipment
7. *Operation quality Management system, working procedures and other file directories
8. Basic introduction and function description of the computer information management system
9. *Authorization certificate of the person in charge
10 . *Scanned version of application form signed and stamped with official seal
3. The difference between licensing and filing is that the license must have item 8: Basic introduction and function description of the computer information management system, and a computer management system . Do companies need to apply for a health license to issue a Class III medical device license?
Consult the local administrative approval central drug monitoring window and the Medical Device Division of the Food and Drug Administration.
The information required for the Class III medical device business license mainly includes:
1. Written application, signature (stamped)
2. Fill in the "Medical Device Business License Application Form" in triplicate
3. Photocopy of the original and duplicate industrial and commercial business license, or industrial and commercial pre-certification letter
4. Internal organizational chart of the enterprise, warehouse . Reasonable layout of business premises (schematic diagram); business address of the enterprise (schematic diagram of location).
5. Photocopies of qualification certificates (college degree), academic certificates, and ID cards of the company’s legal representative, person in charge, and quality management personnel. Legal person, responsible person from resume.
6. Letter of appointment of enterprise management personnel
7. Roster of enterprise employees (name, gender, age, education, professional title, position)
8 , Physical examination certification materials for personnel who have direct contact with medical devices within the enterprise.
9. Lease agreement, application form for warehouse address identification. (More than two years)
10. Catalog of products operated by the enterprise (product name, specification, manufacturer, registration number, etc.)
11. Valid certification materials for the products operated by the enterprise (product registration certificate , production and operation enterprise license). Photocopies should be stamped in red.
12. Enterprises should formulate the following management systems based on their actual conditions:
(1) Business operation quality management system
(2) First-time operation of varieties Quality audit system
(3) Returned product management system
(4) Unqualified product management system
(5) User access system
(6) Hygiene management system
(7) After-sales training, maintenance and service system
(8) Quality acceptance and delivery review system
(9) Management system for medical devices with validity period
(10) Management system for special managed medical devices and valuable varieties
(11) Those who operate third-class medical devices should establish quality standards Tracking and Adverse Reaction Reporting System
13. A written guarantee that the source and destination of the products sold by the operating company are clear and traceable.
14. The applicant’s self-guaranteed statement on the authenticity of the information provided
15. If the corporate legal person, person in charge, business address, warehouse and business products change, the applicant should promptly report to the application bureau again. Requirements for the application period for applying for a Class II medical device production license
If the validity period of the "Medical Device Production License" expires and is extended, the medical device manufacturing enterprise shall submit a "Medical Device Production License" to the original issuing department 6 months before the expiration date. Medical Device Production License" renewal application.
The original license-issuing department shall review the renewal application in accordance with relevant regulations, conduct on-site inspections if necessary, and make a decision on whether to approve the renewal before the expiration of the "Medical Device Production License". If the specified conditions are met, the extension will be granted. Those who do not meet the stipulated conditions will be ordered to make corrections within a time limit; if they still do not meet the stipulated conditions after rectification, they will not be extended and the reasons will be explained in writing. If no decision is made within the time limit, the extension will be deemed to be approved. The new policy explains how to apply for a medical device license. Category II only requires a filing system.
Article 4: According to the risk level of medical devices, medical device operations are subject to classified management.
The operation of Class I medical devices does not require licensing and registration, the operation of Class II medical devices is subject to registration management, and the operation of Class III medical devices is subject to licensing management. How much does it cost to register a Class II and III medical device license
1. It costs nothing to register a medical device license. You just need to apply to the local department and pay a cost of about RMB 10; A medical device operating enterprise shall be reviewed and approved by the drug regulatory department of the People's Government of the province, autonomous region, or municipality directly under the Central Government, and a "Medical Device Operating Enterprise License" shall be issued.
2. Detailed view:
:tieba.baidu./p/4396825437
Whether the third category of medical device license can operate the same type of second category Coding products
What you mean is that you have a Category III business license with the same coding category, and now you want to operate Category II medical devices with the same coding, right? This is not possible. Category III and Category II are separate. If you want to sell Category II, you still need to apply for a Category II business registration certificate. How many procedures are required to change the address of a medical device production license and register a product? (Class I, Class II, Class III medical devices) What are the site requirements for applying for a Class II medical device production license?
The site can be divided into production area, storage area, office area and inspection area.
The site qualifications include 1. Having a real estate certificate (industrial or maternity building, non-residential).
The area is suitable for the production scale.
There are no major pollution sources in the environment surrounding the production.
Find Aozhida Medical Equipment Service Group! If Shanghai has a Class III medical device production license, do you still need to apply for a Class II medical device?
This depends on the coverage of your production license. If the classification codes are consistent, you can apply for an additional production license. Project. This eliminates the need for inspection by the Food and Drug Administration.