Medical device license class I class II class III difference?
According to the latest "supervision and management of medical devices regulations" (State Council Decree No. 650) and "quality management standard for the operation of medical devices", first of all, we have to understand that medical devices are divided into three categories: Class I, Class II, Class III, the current operation of a class of products is not required to apply for a license to operate a medical device device, the operation of a class of products is required to apply for the second class of medical equipment business filing vouchers, operating three classes of The product is to apply for the medical equipment business license.
What is the charge for a Class I medical device?
A class of medical devices for the record does not charge. After the reform of the registration system, for a class of medical devices for the record, the record of the registration authority no longer charge any fees, the state has canceled the record of registration of all kinds of administrative fees.
As long as a class of medical equipment operators to submit the record materials are complete, after the audit, the record authorities will be a class of medical devices for the record registration, no charge. Therefore, a class of medical devices for the record without charge.
Criteria for a class of medical devices inspection program?
In the international standard classification, Class I medical device testing involves medical equipment, laboratory medicine, sterilization and disinfection.
In China's standard classification, Class I medical device testing involves medical device synthesis, extracorporeal circulation, artificial organs, prosthetic devices, general and microsurgical instruments.
(1), YY/T1805.3-2022 Tissue-engineered medical device products collagen part 3: collagen content detection based on characteristic peptide determination - liquid chromatography-mass spectrometry
(2), YY/T1805.2-2021 Tissue-engineered medical devices Product collagen part 2: type I collagen molecular weight detection - sodium dodecyl sulfate polyacrylamide gel electrophoresis method
(3), YY/T1695-2020 human assisted reproduction technology medical devices culture fluid in the amino acid detection method
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(4) ), YY/T1561-2017 Detection of residual α-Gal antigen in animal-derived scaffold materials for tissue engineering medical device products
Industry standard-pharmaceuticals, standard on the testing of class I medical devices
(5), YY/T1454-2016 Basic requirements for in vitro diagnostic medical devices for self-testing
(6), YY/ T0681.11-2014 sterile medical device packaging test methods Part 11: visual detection of medical packaging seal integrity
(7), YY/T0681.5-2010 sterile medical device packaging test methods Part 5: internal pressure method to detect gross leakage (bubble method).
Class I medical device filing process?
The first class of medical device products for the record, by the filer to the location of the municipal people's government responsible for drug supervision and management of the department to submit the record 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, 1 photocopy)
3. Product Technical Requirements (1 electronic copy, 1 copy)
4. Electronic 1, a copy of 1)
5. Clinical evaluation information (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 basis: "Regulations for the Supervision and Administration of Medical Devices"
Legal basis: "Medical Devices Supervision and Administration"
The first class of medical devices shall be implemented in accordance with Article 13 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.
What is the meaning of the device record number?
The device record number is the medical device or health effects of the cream and other products of the approval number. It is a medical device product. Does not belong to the drug, belongs to the medical device. Is a low degree of risk, the implementation of national routine management can ensure its safety, effective medical devices.
Mechanisms that have clinical efficacy can be written directly on the manual, are tested by the clinical view. The product is more secure, and it has been filed by the State Food and Drug Administration.