Three kinds of medical equipment record table how to query?
State Drug Administration web page medical device product query portal can be viewed!
How to punish the third class of medical devices?
Opinion 1: the medical institution from the medical equipment production and management of medical institutions without the qualification of medical equipment purchase of medical equipment, in violation of the "supervision and management of medical equipment regulations" Article 26, should be based on the regulations of Article 42 to make the appropriate penalties.
Perspective two: the medical institution purchased a class of medical devices and three categories, should be treated differently. For a class of medical devices, because the "supervision and management of medical devices regulations" does not provide for the production and management of a class of medical devices to obtain a license, for the purchase of a class of medical devices does not apply to the "supervision and management of medical devices regulations" Article 42, should not be punished. For the purchase of Class III medical devices, a violation of the "supervision and management of medical equipment regulations" Article 26, should be based on the regulations of Article 42 to make the corresponding punishment.
Opinion: "Medical Device Supervision and Administration Regulations" Article 26 of the legal meaning is that the medical institutions must have legal qualifications from the purchase of medical equipment. A class of medical equipment business does not need to obtain a license, but the "supervision and management of medical devices regulations" Article 24 provides that the opening of the first class of medical equipment business enterprises, should be to the provincial, autonomous regions, municipalities directly under the Central People's Government of the drug supervision and management department for the record. The medical institution has not been filed by other medical institutions to purchase a class of medical devices, should belong to the production and operation of medical equipment from the unit without medical equipment qualifications to purchase medical equipment, should be based on "supervision and management of medical devices regulations" Article 42 to make the corresponding punishment. So I agree with the first point of view. However, in the implementation of administrative penalties, should take into account the circumstances of the violation and the consequences of harm, to give a lighter or less severe punishment.
Related legal provisions link "supervision and management of medical devices regulations" Article 24: the opening of the first class of medical equipment business enterprises, should be to the provincial, autonomous regions, municipalities directly under the Central People's Government of the drug supervision and management department for the record.
"Supervision and Management of Medical Devices Regulations" Article 26: Medical equipment business enterprises and medical institutions should obtain "medical equipment manufacturer license" from the manufacturer or "medical equipment business license" of the business enterprise to purchase qualified medical devices, and inspection of product certification.
"Supervision and Administration of Medical Devices Regulations" Article 42: Violation of the provisions of these regulations, medical institutions use no product registration certificate, no certificate of conformity, expired, invalid, out of medical equipment, or from the "medical device manufacturer license", "medical device business enterprise license" of the enterprise purchase of medical equipment, by the people's government at or above the county level of the drug supervision and management department shall order rectification Confiscate the illegal use of products and illegal income, illegal income of more than 5,000 yuan, and impose illegal income of more than one times five times the following fine; no illegal income or illegal income of less than 5,000 yuan, and impose a fine of more than 5,000 yuan 20,000 yuan.
How to file a class I medical device license?
The first class of medical device products for the record, by the filer to the municipal people's government in charge of drug supervision and management of the municipal people's government to submit the filing information.
Processing materials in general:
1. "Class I Medical Device Filing Form" (the original original (collected) 1, 1 electronic copy)
2. safety risk analysis report (1 electronic copy, a copy of 1)
3. product technical requirements (1 electronic copy, a copy of 1)
4. product testing report ( Electronic 1, a copy of 1)
5. Clinical evaluation data (electronic 1, a copy of 1)
6. Product manuals and minimum sales unit labeling design samples (electronic 1, a copy of 1)
7. Manufacturing information (electronic 1, a copy of 1)
8. Supporting documents (copy of business license, copy of organization code certificate) Organization code certificate copy) (1 electronic, 1 copy)
9. Declaration of conformity (original original (collected) 1, 1 electronic)
10. Proof of authorization of the operator and the operator's original identity card and a copy of the original (original original (collected) 1, 1 electronic)
Legal authority: "Regulations for the Supervision and Administration of Medical Devices"
Legal authority: "Regulations for the Supervision and Administration of Medical Devices"
Lawful basis: "Medical Device Supervision and Administration"
The first class of medical devices shall be implemented in accordance with Article XIII of the Regulations. Article XIII of the first class of medical devices to implement the product record management, the second class, the third class of medical devices to implement product registration management.
Medical device registrants, filers should strengthen the quality management of medical devices throughout the life cycle, the development, production, operation, use of the whole process of medical devices, safety, effectiveness and bear responsibility according to law.
Three types of medical devices need to be what the department for the record for how long the period of validity?
Three types of medical devices need to be submitted to the State Council drug supervision and management department of the registration application information, medical device registration certificate is valid for five years.
June 1, 2021, the implementation of the "supervision and management of medical devices regulations" Article XIII provides that the first class of medical devices to implement the management of product filing, the second class, the third class of medical devices to implement the management of product registration.
Article 16 provides for the application for registration of Class III medical device products, the applicant for registration shall submit the registration application information to the State Council Drug Administration
Article 22 provides that 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 for six months before the expiration of the original registration department to apply for renewal of registration.
What about the expiration of Class III medical devices?
Enterprises applying for replacement of the "medical device business license", should be in the expiration of 40 working days to 6 months before the expiration of the business location of the Food and Drug Administration sub-bureau to apply for and submit the following relevant information:
(1) "Shanghai Medical Device Business Enterprise License Renewal Application Review Form";
(2) "Medical Device Business Enterprise License Renewal Application Material Registration Form
(3) "Medical Device Business License" copy;
(4) stamped with the seal of the "Business License" copy;
(5) enterprise quality management responsible person's identity card, copy of proof of qualifications or titles, and personal resume;
(6) enterprise quality management personnel qualifications or certificates of title copy
(7) enterprise medical device business quality management system catalog.