Apply for Class II medical devices for the record, what are the requirements for business premises and personnel?
Should have with the scale and scope of operation of the business premises and storage conditions and so on.
Engaged in the second class of medical devices business, by the business enterprise to the municipal people's government of the location of the municipal people's food and drug supervision and management department for the record and submit its compliance with the conditions set out in Article 29 of the Ordinance to prove that the business activities in the medical device, there should be with the scale of operation and the scope of operation of the business premises and storage conditions, as well as with the operation of the medical device quality management system and quality management institutions or personnel. Management system and quality management organizations or personnel.
Medical equipment business enterprises, the use of units to purchase medical devices, should check the qualifications of the supplier and medical equipment qualification documents, the establishment of purchase inspection record system. Engaged in the second and third class medical device wholesale business and the third class medical device retail business business enterprises, should also establish a sales record system.
Where to check the company's Class II record?
The first step is to log into the official website of the Food and Drug Administration of your province.
The second step, enter the "province Food and Drug Administration" official home page, pull down, find the "data query" item, click to enter the data query page.
The third step, in the "database query" item click on "medical devices", find and click on the "Class II medical device business record certificate.
The fourth step, in the right side of the "advanced query" can be entered: the record number / enterprise name and other relevant information, click on "search" to query. Tap the "query results" can be viewed to find the need to find the enterprise's "Class II Medical Device Business Record Certificate" related documents.
How is the filing of Class 2 medical device certificates publicized?
According to the "supervision and management of medical equipment business approach" Article 39 of the medical device business enterprises do not have the original operating license conditions or with the filing information does not match and can not be contacted, by the original issuance of permits or filing department after the announcement, according to law, the cancellation of its "Medical Device License" or in the filing of the second class of medical equipment business information to be marked, and to the community announcement. Now, because the enterprise took the initiative to apply for labeling, I intend to mark Huaihua City, Huaiyi old people's health pharmacy class II medical device business record certificate, is hereby made public, the publicity period: May 7, 2021 to May 12, 2021. No objection after the expiration of the publicity period, the Bureau will be marked.
Contact Tel: 0745-2855418.
Correspondence Address: Hecheng District, Huaihua City, Taiping Bridge Taiping Lane No. 3 former Huaihua City Bureau of Industry and Commerce
Postal Code: 427000
Hereby announced.
What is the difference between a medical device Class II business record certificate and a medical device business enterprise license?
The operation of Class II products is required to apply for Class II medical device business filing certificate, and the operation of Class III products need to apply for a medical device business license. The difference between the two is as follows:
One, the second class of business filing certificate needs to be filed, while the medical device business license is the approval system.
Two, the second class of medical devices business filing certificate office address sampling, medical device business enterprise license office address shall be verified, the requirements of the medical device management system is complete, complete personnel, office, warehouse equipment, cold storage in line with the acceptance criteria.
Three, the application conditions are different:
1, the application for the second class of medical devices business record certificate and medical device business license medical device manufacturers should have the following conditions:
(1) in line with the "supervision and management of the production of medical devices," Article VII, Article VIII of the regulations;
(2) the enterprise's production, quality and technical The person in charge of production, quality and technology should have with the production of medical devices appropriate professional competence, the person in charge of quality shall not be concurrently in charge of production;
(3) with the production of products and production scale of the production of equipment, production, warehousing sites and the environment. Enterprises producing medical devices have special requirements for the environment and equipment, should be in line with national standards, industry standards and relevant state regulations;
(4) with the production of varieties and production scale of quality inspection organizations and quality inspection capacity;
(5) with the production of medical devices related to technical standards.
2, apply for a medical device license business enterprises, in addition to the above requirements should be met, but also should have the following conditions:
(1) meet the quality management system requirements of the internal auditor not less than two;
(2) related professional title or college degree or above, not less than two full-time technical staff.
Expanded information:
Medical devices are divided into three categories: Class I, Class II and Class III, and the current operation of a class of products does not need to apply for a medical device apparatus business The license is not required to apply for a medical device license.
The state of medical devices in accordance with the degree of risk of the implementation of classification management is as follows:
The first category is a low degree of risk, the implementation of routine management can ensure its safety and effectiveness of medical devices. Such as: surgical instruments (knife, scissors, pliers, tweezers, hooks), scraping board, medical X-ray film, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags and so on.
The second category is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices. Such as: medical suture needles, sphygmomanometers, thermometers, electrocardiographs, electroencephalograms, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasound disinfection equipment, non-absorbable sutures, condoms and so on.
The third category is a higher risk, need to take special measures to strictly control the management of medical devices to ensure their safety and effectiveness. Such as: implantable cardiac pacemakers, corneal contact lenses, artificial crystals, ultrasound tumor focusing knife, hemodialysis devices, implantable devices, vascular stents, comprehensive anesthesia machine, dental implant materials, medical absorbable sutures, intravascular catheters and so on.
What are the requirements for filing Class II medical devices?
Should have with the business scale and scope of operation of the business premises and storage conditions.
Engaged in the operation of Class II medical devices, by the business enterprise to the municipal people's government of the location of the municipal people's food and drug supervision and management department for the record and submit its compliance with the conditions set out in Article 29 of the Ordinance, that is, to engage in the operation of medical devices, there should be with the scale of operation and the scope of operation of the business premises and storage conditions, as well as with the operation of the medical device quality management system and quality management institutions or personnel. Management system and quality management organizations or personnel.
Medical equipment business enterprises, the use of units to purchase medical devices, should check the qualifications of the supplier and medical equipment qualification documents, the establishment of purchase inspection record system.
Engaged in the second and third class of medical devices wholesale business and the third class of medical devices retail business enterprises, should also establish a sales record system.