The second class of Class III medical devices to implement product registration management.
The first class of medical devices to implement product record management. Class II and Class III medical devices to implement product registration management.
The first class of medical devices within the territory of the filing, the filing of the municipal level responsible for the supervision and management of drugs submitted to the municipal level filing information.
The second class of medical devices within the province, autonomous regions and municipalities directly under the central drug supervision and management department for review, approval and issue of medical device registration certificate.
The third class of medical devices within the State Drug Administration review, approval and issue of medical device registration certificate.
Imported Class I medical devices for the record, the filer to the State Drug Administration to submit the record information.
Imported Class II, Class III medical devices by the State Drug Administration for review, approval issued after the medical device registration certificate.
How to classify medical device products:
The state medical devices in accordance with the degree of risk of the implementation of classification management. The first category is a low degree of risk, the second category is with medium risk; the third category is with high risk.
What is a medical device:
Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body, including the required computer software; their utility is mainly obtained by physical means, etc., and is not obtained by pharmacological, immunological, or metabolic means or is only auxiliary despite the involvement of these means. modalities are involved, but only in an ancillary manner; for the purpose of:
(i) diagnosis, prevention, monitoring, treatment, or mitigation of disease;
(ii) diagnosis, monitoring, treatment, mitigation, or compensation of function of an injury;
(iii) testing, substitution, modulation, or support of physiological structures or processes;
(iv) support or maintenance of life;
(v) and (vi) the use of a computer software or other similar or related items, including computer software, as required. maintenance;
(v) pregnancy control;
(vi) providing information for medical or diagnostic purposes through the examination of samples from the human body.
Legal basis:
"Supervision and Administration of Medical Devices Business" Article 38 Business enterprises engaged in the wholesale business of Class II and Class III medical devices as well as the retail business of Class III medical devices shall establish a sales record system. Sales record information should be true, accurate, complete and traceable. Sales records include:
(a) the name of the medical device, model, specifications, registration certificate number or record number, quantity, unit price, amount;
(b) the production of medical devices, or serial number, use or expiration date, date of sale;
(c) the medical device registrant, the filing of the name of the producer and entrusted production enterprises, production license number or record number. No. or record number.
Enterprises engaged in the second and third class medical device wholesale business, sales records should also include the name of the purchaser, address, contact information, the relevant license document number or record number.
Sales records should be kept until 2 years after the expiration date of the medical device; no expiration date, not less than 5 years. Implantable medical devices sales records should be kept permanently.