First of all, the manufacturer needs to check whether its own production conditions to meet the following requirements:
1, with the production of medical devices and production sites, environmental conditions, production equipment and professional and technical personnel;
2, the enterprise should have with the production of products and production scale of the production of equipment, production, warehousing sites and the environment (need to be dust-free) Aseptic workshop);
3, the production of medical devices to carry out quality inspection of the organization or full-time inspectors and inspection equipment;
4, the enterprise's production, quality and technical personnel should have the production of medical devices and the production of appropriate professional competence, and to master the national supervision and management of medical devices and the supervision and management of laws, rules and regulations, as well as related product quality, technical provisions of the product. The person in charge of quality shall not be concurrently in charge of production.
Which, the person in charge of the enterprise requirements: with medical devices related professional (related professional refers to medical devices, biomedical engineering, machinery, electronics, medicine, bioengineering, chemistry, pharmacy, nursing, rehabilitation, testing, management and other professions, hereinafter the same) above the college level or above the intermediate professional and technical title, and should have more than 3 years of experience in quality management of medical device business.
If the enterprise meets the above conditions, you can prepare the information for the process application, the specific information required is as follows:
1, business license, official seal (if you can not provide the official seal, need to be matched with a number of signed documents stamped)
2, the legal representative, the person in charge of production, the person in charge of technology, the quality of the person in charge of the full-time inspector (2), the person in charge of procurement, After-sales service personnel identification, proof of education or title.
3, proof of production site (own property, provide a copy of the "real estate license"; leased property, provide a copy of the "lease contract and red lease certificate")
4, the list of major production equipment and testing instruments
5, product technical requirements for medical devices, product specifications, labeling design samples, samples
6, the product of the process flow Figure
Legal basis:
"Supervision and Administration of Medical Devices Regulations" Article 23 Medical device business enterprises shall meet the following conditions:
(a) with its business of medical devices compatible with the business site and environment;
(b) with its business of medical devices compatible with the Quality inspection personnel;
(c) with its business with the medical equipment products appropriate technical training, maintenance and other after-sales service capabilities.
"Supervision and Administration of Medical Devices Regulations" Article 24 to open the first class of medical equipment business enterprises, shall be to the provincial, autonomous regions and municipalities directly under the Central People's Government of the drug supervision and management department for the record.
The opening of the second and third class of medical equipment business enterprises, should be by the provinces, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department for examination and approval, and issued a "medical device business license. No "medical equipment business license", the administrative department for industry and commerce shall not issue a business license.
"Medical Device Business License" is valid for five years, the expiration date should be re-examined and issued. Specific measures developed by the State Council Drug Administration.
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The above answer, only the current information combined with my understanding of the law to make, please be careful with your reference!
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