The filing of Class I medical device refers to the handling of Class I medical device product certificates in accordance with the relevant requirements of the Regulations for the Supervision and Administration of Medical Devices, which is equivalent to the product's ID card for identifying the product's name, use, description, expiration date, etc., as well as the manufacturer, commissioned manufacturer and other information to prove that the product has been filed by the drug supervision and management authorities and has the force of law.
Filing refers to the registrant to submit the product filing materials, to make the relevant commitments, and is responsible for the authenticity of the filing materials, completeness and compliance; market supervision and management department shall file the filing materials submitted by the filer to meet the requirements of the form of review filing for inspection.
Introduction to the filing of Class I medical devices
According to the "Regulations for the Supervision and Administration of Medical Devices" (2021) and related laws and regulations, Class I medical devices are subject to product filing management, and do not need to obtain a certificate of registration and a production license, and only need to be filed with the local municipal drug supervision and management department.
The filing here refers to the filing of Class I medical device products, and obtaining a Class I medical device product filing certificate.
Types of production
Self-produced: a Class I medical device product registration certificate and a Class I medical device production registration certificate are required.
Commissioned production record: only for the first class medical device record certificate.
Requirements for the filing of Class I medical devices
(1) The declared products are listed in the "Class I Medical Device Catalog" or "Class I In Vitro Diagnostic Reagent Subclass";
(2) The applicant company has a production site that meets the production conditions; (except for the commissioned production)
(3) The production company should be equipped with the appropriate management personnel, and the management personnel should meet the title or academic requirements. (Except for commissioned production)
The first class of medical devices product filing application information
1. filing information directory
2. applicants in the State Food and Drug Administration website home page licensing services, click on the online office, enter the medical device production and operation of the filing of the information system to fill out the online;
3. fill out the online form, print the online Class I Medical Device Filing Form" in triplicate (the application form shall not be filled out manually), and click the submit button;
4. Class I Medical Device Filing Form;
5. Safety Risk Analysis Report;
6. Product Technical Requirements;
7. Product Inspection Report;
8. Clinical Evaluation Data;
9. Product specifications and minimum sales unit labeling design samples
10. Manufacturing information;
11. Supporting documents;
12. Declaration of conformity;
How long is the validity period of the filing voucher for Class I medical device products?
About the medical device filing certificate, it is valid for five years, but after five years, if you still want to continue to operate, then you can go to the local Food and Drug Administration for renewal, as long as the submission of relevant information can be.
Filing requirements for the production of Class I medical devices:
Engaged in the production of Class I medical devices, by the manufacturer to the municipal people's government of the location of food and drug supervision and management department for the production of Class I medical devices for the record.
Enterprises should have the conditions:
(1) to meet the "supervision and management of medical devices regulations" Article 20 requirements;
(2) the filer should be in the municipal jurisdiction of the law for registration of the enterprise, industrial and commercial "business license" within the period of validity;
(3) the filer should be the establishment of the quality management system associated with the development and production of the product, and maintain effective operation;
(4) with the production of products corresponding to the production site, environmental conditions, infrastructure;
(5) with the production of products corresponding to the technicians, testing instruments, management system, after-sales service capabilities;
--- -No address no personnel treasure for a class two class three medical devices
--- a hand for a class of medical equipment product record, production record
--- -The whole process on behalf of the three classes of medical equipment license permit, 6840, new crown reagent, contact lenses, hearing aids, implantation and intervention products.
Legal basis:
According to the "supervision and management of medical devices regulations (State Council Decree No. 650)," Article XV
The registration certificate of medical devices is valid for five years. The expiration of the validity of the need to renew the registration, should be valid six months before the expiration of the original registration department to apply for renewal of registration. In addition to the third paragraph of this article, the continuation of the application for registration of food and drug supervision and management departments should be in the medical device registration certificate before the expiry of the validity of the decision to grant the continuation. Late decision, deemed to be allowed to continue.
One of the following circumstances, not to renew the registration:
First, the registrant did not apply for renewal of registration within the specified period;
Second, the mandatory standards for medical devices have been revised, apply for renewal of registration of medical devices can not meet the new requirements;
Third, for the treatment of rare diseases and respond to emergencies of public **** health incidents of urgent need of medical devices, not within the specified period of time. Medical devices, not within the prescribed period of time to complete the medical device registration certificate contains matters. Class II business filing application to the can have been used without a deadline.