1, engaged in medical equipment business activities, there should be with the scale and scope of business operations and storage conditions;
2, with the operation of medical devices and quality management system and quality management organizations or personnel.
3, for the second class of medical devices business registration address requirements:
(1) office area of not less than 50 square feet
(2) warehouse area of not less than 50 square feet; (including in vitro diagnostic reagents need to be refrigerated warehouses)
(3) including disposable supplies, if the requirements of the office address and the warehouse area together can not be less than 150 square feet Note: The business premises and warehouse are not less than 150 square feet. : business premises and warehouses are not allowed to set up in residential homes.
Acceptance of applications for business license food and drug supervision and management departments should be accepted within 30 working days from the date of review, if necessary, the organization verification. To meet the prescribed conditions, and issued a medical device license; do not meet the prescribed conditions, not licensed and a written explanation of the reasons.
Medical device license is valid for 5 years. The expiration of the validity of the need for continuation, in accordance with relevant legal provisions for the continuation of the procedures.
Medical equipment business enterprises, the use of units purchasing 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 enterprises, should also establish a sales record system.
Record matters include:
1, the name, model, specifications, quantity of medical devices;
2, the production batch number of medical devices, the expiration date, the date of sale;
3, the name of the manufacturer;
4, the name of the supplier or the purchaser, address and contact information;
5, the relevant license Proof of document number, etc.
Legal basis: "supervision and management of medical devices regulations" Article 48
Medical devices should be used with the use of medical devices, the number of varieties of storage space and conditions. Medical device use units should strengthen the technical training of staff, in accordance with product instructions, technical specifications and other requirements for the use of medical devices.
Medical equipment using units configured with large medical equipment, should be in line with the State Council competent department of health to develop large-scale medical equipment configuration planning, and its functional positioning, clinical service needs are appropriate, with the corresponding technical conditions, supporting facilities and have the appropriate qualifications, capabilities of professional and technical personnel, and by the people's government at or above the provincial level health department for approval, to obtain a large medical equipment configuration License.
Large medical equipment configuration management by the State Council health department in conjunction with the relevant departments of the State Council. Catalog of large medical equipment by the State Council health department of the State Council departments concerned proposed, reported to the State Council for approval and implementation.