Medical equipment business license is a medical device business enterprises must have a document
Opening the second class of medical equipment business enterprises, should be to the province, autonomous region, municipal people's government of the People's Drug Administration
Supervision of the management department for the record; open the third class of medical equipment business enterprises, should be by the province, Autonomous regions, municipalities directly under the Central People's Government of the drug supervision and management department for examination and approval, and issued the "medical device business license". Medical equipment business license is now a post approval, business administration department issued a business license to apply for
approval. The Medical Device Business License is valid for 5 years. The state of medical devices in accordance with the risk level of implementation of classification management. The first class of medical devices is a low risk, the implementation of routine management can ensure the safety and effectiveness of medical devices, such as scalpels, surgical scissors, manual beds, medical ice packs, cooling pads, etc., its products and production activities by the location of the municipal food and drug regulatory authorities to implement record management. Business activities are all liberalized, neither permit nor record, only need to obtain a business license issued by the business sector. The second class of medical devices is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices, such as our daily life in the common band-aid, condoms, thermometers, sphygmomanometers, oxygen concentrators, nebulizers, etc., its products and production activities by the provincial food and drug regulatory departments to implement licensing and management, respectively, issued by the "Medical Device Registration Certificate" and "Medical Device Manufacturing License". Business activities by the municipal food and drug regulatory departments to implement record management;?
The third class of medical devices is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices, such as common infusion sets, syringes, intravenous retention needles, cardiac stents, respiratory machines, CT, nuclear magnetic **** vibration, etc., its products and production and operation activities by the State Administration, the provincial food and drug regulatory departments and the municipal food and drug regulatory departments in the districts, respectively The implementation of licensing management, respectively, issued by the "Medical Device Registration Certificate", "Medical Device Manufacturing License", "Medical Device Business License".
Medical equipment business license is a medical device business enterprises must have the documents, the opening of the first class of medical equipment business enterprises, should be to the provinces, autonomous regions, municipalities directly under the Central People's Drug Administration for the record;
Opening the second, third class of medical equipment business enterprises, should be by the provinces, autonomous regions, municipalities directly under the Central People's Drug
Personal Product Supervision and Administration Department for examination and approval, and issued the "Medical Device Business Enterprise". and issued a "medical device business enterprise license"
Medical device license business premises, warehouse area requirements:
1.? Management of the second, third-class medical device products, the business premises should be no less than 40
square meters, the use of legal entity branches of the business premises should be no less than 25 square meters (except across the municipal setup); business hearing aids, the use of the business premises should be no less than 25 square meters; business contact lenses and care solutions, the use of the business premises should be no less than 10 square meters. Should not be less than 10 square meters.
2. Business Class II, Class III medical devices (hearing aids, contact lenses and nursing fluids, disposable
use of sterile medical equipment products in vitro diagnostic reagents, 6846 implantable materials and artificial organs, 6877 interventional
devices excluded), the warehouse should be used in an area of not less than 30 square meters; the business of single-use sterile medical devices
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, the warehouse should be in the same building, the use of the area should not be less than 200 square meters.
3. Branches of legal entities (except for the establishment of municipalities across the region) and specializing in medical equipment and equipment, may not set up a separate warehouse, but should be stamped with a legal entity or authorized to operate the product manufacturer (including import
import agents) original seal of the original seal of the relevant unified procurement and distribution, unified quality management, installation and after-sales service commitments, as well as specializing in product Registration certificate, authorization documents and other proof.
4. Business hearing aids or contact lenses and their care fluids, you can not set up a warehouse, but there should be a special cabinet.
5. Declared business premises and warehouses in principle in the same administrative area near the set up, and shall not be
located in civilian homes, troops, public security, armed police camps.
Enterprise personnel qualification requirements:
1. Business Class III medical device products, quality management, quality institutions should have a nationally recognized, and business products related to the profession (medical devices, biomedical engineering, machinery, electronics, etc.) college degree or above, or intermediate or above the technical title of the relevant professional. Operation of single-use sterile medical devices, there should be more than one medical device quality management system with an internal auditor certificate of the internal auditor (not by the quality manager at the same time).
2. Management of Class II medical device products, quality management, quality institutions should have a national
recognized, and the management of products related to the profession (medical devices, biomedical engineering, machinery, electronics, etc.) above junior college education or technical title above the primary level of the relevant professional.
3. Management of the second and third class of medical equipment products, technical training and after-sales service personnel (medical devices, biomedical engineering, machinery, electronics) and other products should be operated with the management of the relevant professional secondary school education or more junior technical title.
4. Business hearing aids or contact lenses and care fluids, quality management should be recognized by the state third-party institutions or authorized to operate the manufacturer (including import agents) contact lens fitting technology training.
5. The quality manager and the head of the quality organization shall not be part-time.
Apply for a certificate of medical device business license, the materials required are as follows:
1.? Management of the second and third class of medical equipment products, the business premises should be used in an area of not less than 40 square meters, the use of the business premises of the branch of the legal entity should be used in an area of not less than 25 square meters (except across the set of municipalities
setting); business hearing aids, the use of the business premises should be used in an area of not less than 25 square meters; the operation of contact
glasses and nursing fluids, the Business premises should be no less than 10 square meters.
2. Management of Class II, Class III medical devices (hearing aids, contact lenses and nursing fluids, single-use sterile medical device products in vitro diagnostic reagents, 6846 implantable materials and artificial organs, 6877 interventional devices, except), the warehouse should be used not less than 30 square meters; the operation of single-use sterile medical devices, warehouses should be in the same building, the use of the area should be less than 200 square meters. Area should be not less than 200 square meters.
3. Legal entity branches (except for the establishment of municipalities across the region) and specializing in medical equipment and equipment, may not set up a separate warehouse, but should be stamped with a legal entity or authorized to operate the product manufacturer (including the import agent) the original seal of the original seal of the relevant procurement and distribution of uniform quality management, installation and after-sales service commitments, as well as specializing in the product's registration, authorization documents and other evidence. Documents and other proof.
4. Business hearing aids or contact lenses and their care solution, you can not set up a warehouse, but there should be a special cabinet storage.
5. Declared business premises and warehouses in principle in the same administrative area near the set up, and shall not be part-time.
Enterprise personnel qualification requirements:
1. Business Class III medical device products, quality management, quality institutions should have a national
recognized, and business products related to the profession (medical devices, biomedical engineering, machinery, electronics, etc.) college degree or above, or intermediate or above the technical title of the relevant professional. Management of single-use sterile medical devices, there should also be more than one holding a medical device quality management system internal auditor certificate of the internal auditor (not by the quality manager at the same time).
2. Management of Class II medical device products, quality management, quality institutions should have a nationally recognized, and management of products related to the profession (medical devices, biomedical engineering, machinery, electronics, etc.) above junior college education or technical title above the primary level of the relevant profession.
3. Management of second and third class medical device products, technical training and after-sales service personnel (medical devices, biomedical engineering, machinery, electronics) and so on should have with the management of products related to the profession of secondary school education or junior or above technical title.
Recognized, and business products related to the profession (medical equipment, biomedical engineering, mechanical, electronic, etc.) college degree or above, or more than intermediate technical title in related disciplines. Management of single-use sterile medical devices, there should also be more than one holding a medical device quality management system internal auditor certificate of the internal auditor (not by the quality manager at the same time).
2. Management of Class II medical device products, quality management, quality institutions should have a nationally recognized, and management of products related to the profession (medical devices, biomedical engineering, machinery, electronics, etc.) above junior college education or technical title above the primary level of the relevant profession.
3. Management of second and third class medical device products, technical training and after-sales service personnel (medical devices, biomedical engineering, machinery, electronics) and other products should be operated with the relevant professional secondary school education or more junior technical title.
4. Business hearing aids or contact lenses and care fluids, quality management should be recognized by the state third-party institutions or authorized to operate the production company (including import agents) contact lens fitting technology training.
5. Quality management and quality organization shall not be part-time.