For 2,3 class medical equipment business license

Medical device license conditions 1, the use of business premises area shall not be less than 40 square meters, the use of branch area shall not be less than 25 square meters (in addition to the city across the region); hearing aid business, the use of business premises area shall not be less than 25 square meters; business contact lenses and care solutions, the use of business premises area shall not be less than 10 square meters.

2, the use of warehouse area of not less than 30 square meters; the operation of single-use sterile medical devices, warehouses should be located in the same building, and the use of an area of not less than 200 square meters.

3, quality management personnel and quality institutions should have a nationally recognized product-related professional, college degree or above, or intermediate or higher technical title in related disciplines. Operation of single-use sterile medical devices, there should be more than one with a medical device quality management system internal auditor qualifications of the internal auditor.

Medical device license process

Stage I: application acceptance: the drug regulatory department to review the application materials to meet the basic requirements, decide whether to accept or not to accept the application; (the application needs to be filled out nearly a hundred copies of the information, if the applicant found that there are any problems with the information needs to be returned to the modified, if found to have a significant failure to comply with the place, it will be arrested.)

The second stage: on-site audit: the drug regulatory department assigned one to three auditors to the enterprise site audit, audit mode for the on-site questioning and assessment and on-site inspection and assessment, truthful record of the audit information and audit conclusions, such as not meeting the requirements of the enterprise can be asked to rectify until the rectification meets the requirements, such as rectification still does not meet the requirements given by the notice of the non-license; (the purpose of the audit is to the enterprise) (The purpose of the audit is the legality of the business premises, legality, authenticity of the audit, such as found to be inconsistent with the laws and regulations, rules and regulations, the audit conclusions will have a direct impact on the enterprise whether to pass the audit, and ultimately affect whether the enterprise can obtain a license to operate qualifications)

Third stage: audit, publicity, licensing: by the drug regulatory authorities to approve the relevant information and decide whether or not to give the enterprise license to operate; through the review of the relevant websites, publicize the enterprise information, publicize the relevant information, the relevant websites, the relevant websites, the relevant websites, the relevant websites, the relevant websites. Publication of the relevant information on the enterprise, publicity without objection, then notify the enterprise to obtain a medical device license.

What conditions do I need to apply for a license to operate two or three types of medical devices?

Application conditions:

First, with a quality management organization or full-time quality management personnel. Quality management personnel should have the relevant state professional qualifications or titles;

Second, with a relatively independent business premises, with the scale of operation and business model is appropriate;

Third, with the scale of operation and business scope of the storage conditions, including the characteristics of medical equipment products in line with the requirements of the storage facilities, equipment;

Fourth, the establishment of a sound product quality management system, including purchasing, purchase and acceptance, storage and storage, out of stock Acceptance, warehousing and storage, out of the warehouse review, quality tracking system and adverse event reporting system;

V. With the medical device products with appropriate technical training and after-sales service capabilities, or by a third party to provide technical support.