For the filing of Class I medical device products, the filing person shall submit the filing materials to the pharmaceutical supervisory and administrative department of the municipal people's government with districts.
General situation of handling materials:
1. Record Form for Class I Medical Devices (1 original (received) and 1 electronic)
2. Safety risk analysis report (1 electronic parts and 1 copy)
3. Product technical requirements (1 electronic parts and 1 copy)
4. Product inspection report (1 electronic parts and 1 copy)
5. Clinical evaluation data (electronic version 1 copy, copy 1 copy)
6. Product description and minimum sales unit label design sample (1 electronic parts and 1 copy)
7. Manufacturing information (1 electronic parts and 1 copy)
8. Certification documents (copies of business license and organization code certificate) (electronic part 1 copy, electronic part 1 copy)
9. Declaration of conformity (1 original (received) and 1 electronic parts)
10. Original and photocopy of the agent's authorization certificate and agent's ID card (original 1 copy (received), electronic part 1 copy).
Legal basis: Article 13 of the Regulations on the Supervision and Administration of Medical Devices implements product filing management for Class I medical devices and product registration management for Class II and Class III medical devices.
Medical device registrants and filers should strengthen the quality management of medical devices in the whole life cycle, and be responsible for the safety and effectiveness of the whole process of research and development, production, management and use of medical devices according to law.
Handling the qualification filing of Class II medical devices in Taobao?
Class II medical device qualification filing is not a local business license.
Two different certificates need to apply for a business license first, and then they need to be registered because they are special medical device industries.
Engaged in the operation of second-class medical devices, the operating enterprise shall file with the municipal food and drug supervision and administration department located in the district, fill in the filing form for the operation of second-class medical devices, and submit the following materials:
1. Copy of business license and organization code certificate.
2 copies of the identity certificate, education or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of quality.
3. Description of organization and department settings.
4. Description of business scope and mode of operation.
5. A copy of the geographical location map, floor plan, house title certificate or lease agreement (with house title certificate attached) of the business premises and warehouse address.
6. Catalogue of operating facilities and equipment.
7. Directory of documents such as operation quality management system and working procedures.
8. Agent's authorization certificate.
9. Other supporting materials.
reference data
Record of Class II medical devices
Why do I need a diploma for the filing of Class II medical devices?
College degree or above in medical major is required.
Medical device filing refers to the activities that medical device filers (hereinafter referred to as filers) submit filing materials to the pharmaceutical supervisory and administrative departments in accordance with legal procedures and requirements, and the pharmaceutical supervisory and administrative departments file the submitted filing materials for future reference.
Materials required for the first filing of Class I medical device products;
1. Record Form of Class I Medical Devices
2. Safety risk analysis report
3. Product technical requirements
4. Product inspection report
5. Clinical evaluation data
6. Product description and minimum sales unit label design sample
7. Manufacturing information
8. Business license (Class A limited liability company)
9. Statement of compliance (the statement of compliance shall include: a) a statement of compliance with the requirements for medical device filing; B) Declare that the product conforms to the contents of Category I medical device product catalogue or in-vitro diagnostic reagent classification subdirectory; C) Declare that the product conforms to current national standards and industry standards, and provide a list of standards; D) Declare the authenticity of the filing materials submitted. )
10. Catalogue of application materials
1 1. Letter of appointment
How to apply for medical device registration certificate?
1.
Apply online. The applicant submits the pre-trial application online, and the enterprise should also submit the pre-acceptance number when submitting the paper application materials;
2.
Window acceptance. Enterprises submit paper application materials to the window, and the acceptance personnel check the application materials and make an acceptance decision on the spot;
3.
On-site review. After acceptance, the examiner will review the materials and make a review decision on the spot;
4.
Get the result. The applicant receives the Record Voucher for the Production of Class I Medical Devices or the Decision of Not Passing on the spot at the window.
What types of medical device sales need to be registered?
Domestic sales of Class II medical devices require registration, sales of Class III medical devices require permission, and sales of Class I medical devices have no special requirements. First of all, you have to see what kind of medical equipment you are operating. One type of medical device only needs to cash in the business license, another type of medical device needs to be filed, and the third type of medical device only needs the business license. If it is the second type, it needs a quality supervisor and after-sales personnel. The third type: the business license covers the sale of medical devices, and it also needs a quality supervisor, after-sales supervisor, a salesman, an inspector, two inspectors and, of course, an investigation. Different categories have different needs, and those who don't know can communicate with each other.