A.What are the medical device implementation standards?
1, national standards or industry standards is the need to standardize technical requirements across the country. 2, the need for nationwide unification of technical requirements, national standards should be developed. National standards developed by the State Council administrative department in charge of standardization. There is no national standard and the need to unify the technical requirements of an industry-wide, you can develop industry standards. Industry standards formulated by the State Council administrative department concerned, and reported to the State Council administrative department in charge of standardization for the record, national standards, industry standards are divided into mandatory standards and recommended standards.Two,Registered medical device companies need to meet what conditions?
Medical devices are divided into three categories according to their level of risk, and the conditions for different types of medical devices are different. Today, we focus on the content related to the registration of the second class medical device company. First of all, the registration should have the conditions 1, with the business scope and scale of operation of the quality management organization or quality management personnel, quality management personnel should have a nationally recognized relevant professional qualifications or titles; 2, with the business scope and scale of operation of the business, storage space; 3, with the business scope and scale of operation of the storage conditions, all entrusted to the medical device company. Storage conditions, all entrusted to other medical device business enterprises can not set up storage; 4, with the operation of medical devices appropriate quality management system; 5, with the operation of medical devices appropriate professional guidance, technical training and after-sales service capabilities, or agreed to provide technical support by the relevant organizations. The registration process for Class II medical device companies is no different from the general company registration process, just one more field test and filing process. Regarding the filing of Class II medical devices. Class II medical devices refer to medical devices that have moderate risk and require strict control and management to ensure their safety and effectiveness. According to the "Supervision and Administration of Medical Devices Business Measures", engaged in the operation of Class II medical devices, the business enterprise should be located in the municipal food and drug supervision and management department for the record, fill out the Class II medical device business filing form, and submit the following information: 1, a copy of the business license; 2, the legal representative, responsible person for the enterprise, the person in charge of quality of the identity card, academic qualifications or A copy of the certificate of title; 3, organizational structure and departmental setup; business scope, business mode description; 4, business premises, warehouse address of the geographic location map, floor plan, documents proving property rights or lease agreement (with documents proving property rights) copy; 5, business facilities, equipment directory; business quality management system, work procedures and other documents directory; 6, other supporting materials. p> 6, other supporting materials. The operation of different medical devices, the area of the warehouse requirements are different. If the business is a one-time use of blood transfusion, transfusion, injection of medical equipment companies, the use of storage area should be not less than 100 square meters (different regional policy requirements vary). If the enterprise is operating three types of medical devices, you need to apply for a medical device license. The medical device business license is valid for 5 years, the expiration of the validity of the need for continuation, in accordance with the relevant administrative licensing laws for the continuation of the procedures. If there is a registrant did not apply for renewal of registration within the specified period; the mandatory standards for medical devices have been revised, apply for renewal of registration of medical devices can not meet the new requirements; for the treatment of rare diseases and respond to emergencies in public **** health incidents of urgently needed medical devices, not within the specified period of time to complete the registration of medical devices set out in the matter will not be renewed registration.Three, the process of registering a business is how?
Applying for a medical device company registration process Step 1: Business name approval Today's registration of a license to apply for a name are on the website. Step 2 of the registration process for applying for a medical device company: You have to submit the name of the company, the scope of business, investor information, the status of the place of registration, the registered capital, etc. online and wait for approval. Apply for medical device company registration process Step 3:Get a business license After the industrial and commercial network to submit materials for review, you can go to the Industrial and Commercial Bureau to obtain a license. Application for medical device company registration process step 4: the company engraved company chapter After the enterprise to get the business license, you can engrave the official seal, the normal company must be engraved seal 5 (official seal, financial chapter, legal person chapter, invoice chapter, contract chapter) Application for medical device company registration process step 5: go to the bank to open the enterprise public account You bring the license and seal, go to the The first step in the process is to apply for a bank account with a bank that you are familiar with. The application of medical equipment company registration process step 6: to the tax hall tax identification enterprises to obtain a license within 30 days, you must be registered on the tax office, and from now on every month must be on time to file tax returns. At this point, the steps to register a company is finished, you are able to hand the company opened. The above is organized by me for you to medical equipment, what is the implementation of standards, we can understand that it is reflecting the quality characteristics of the full range of product standards. The implementation of standards is not only the need for business operations, but also the requirements of the law, supervision and inspection basis. The implementation of standards can be divided into: national standards, local standards, industry standards, enterprise standards and so on.