Registered medical device company? You need to meet these conditions

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So how to register a medical device company in Shanghai? Next, Yu Shang Xiaobian will tell you something.
Medical devices can be divided into three categories according to their risk degree, and the processing conditions of different types of medical devices are also different. Today, I will focus on the registration of class II medical device companies.
First of all, the registration should have the conditions
1. It shall have a quality management organization or quality management personnel suitable for its business scope and scale, and the quality management personnel shall have relevant professional qualifications or professional titles recognized by the state;
2. It shall have business and storage sites suitable for its business scope and scale;
3. If the storage conditions are suitable for the business scope and scale, and all the medical devices are entrusted to other medical device business enterprises for storage, the warehouse may not be set up;
4. Have a quality management system suitable for the medical devices;
5. Have the ability of professional guidance, technical training and after-sales service corresponding to the medical devices, or agree to provide technical support by relevant institutions.
Class II medical device company registration process is the same as the general company registration process, but there is an on-site inspection and filing process.
About the filing of class II medical devices. Class II medical devices refer to those with moderate risk, which need strict control and management to ensure their safety and effectiveness. According to the regulations of the measures for the supervision and administration of the operation of medical devices, those engaged in the operation of class II medical devices shall file with the local municipal food and drug administration, fill in the record form for the operation of class II medical devices, and submit the following information:
1. Copy of business license;
2. Copies of the identity certificate, educational background or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of quality;
3. Description of organization and department setting; description of business scope and operation mode;
4. A copy of the geographical location map, plan of the address of the business site and warehouse, the certificate of the property right of the house or the lease agreement (with the certificate of the property right of the house attached);
5. Catalogue of business facilities and equipment; catalogue of business quality management system, working procedures and other documents;
6. Other supporting materials.
The requirements for the area of the warehouse are different with the operation of medical devices. If the business is a disposable medical device enterprise for blood transfusion, infusion and injection, the warehouse area should not be less than 100 square meters (different regions have different policy requirements).
If the enterprise is engaged in three types of medical devices, it needs to apply for a medical device business license. The term of validity of the medical device business license is 5 years. If the term of validity needs to be extended, the renewal procedures shall be handled in accordance with the relevant laws and regulations on administrative license. If a registrant fails to apply for renewal of registration within the specified time limit; the mandatory standards for medical devices have been revised, and the medical devices applying for renewal of registration can not meet the new requirements; if the medical devices used for treating rare diseases and dealing with public health emergencies are not completed within the specified time limit, the renewal of registration will not be allowed.

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Medical device industry: implementation of high value consumables reform plan and improvement of industry standard 2020-12-09

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The medical device industry of economic development zone gets on the fast train 2020-12-09

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Free experience of medical devices "four essentials" to prevent being cheated 2019-08-09

Using free experience to promote medical devices is a marketing method often used by medical device enterprises. Some operators have illegal behaviors such as false publicity and illegal operation in the process of such business activities, which bring hidden dangers to consumers. Recently, Jinan Municipal Market Supervision Bureau of Shandong Province reminded consumers that to participate in the consumption of free experiential medical devices, they should achieve "four requirements". To fully understand the product information. Before participating in the free experience, consumers should fully understand the basic information of medical device products, confirm whether the products are approved legal products, carefully read the labels and instructions of the products, understand the scope of application, precautions and other information of the products, and do not listen to the exaggeration and false publicity of the businesses. Product registration information can be found on the website of the State Drug Administration. It is necessary to analyze the qualification of operators. To operate class II and class III medical devices, it is necessary to obtain class II medical device business record certificate and medical device business license respectively. Consumers should distinguish whether the operator has legal business qualification. To grasp their own health. Consumers should fully understand their health status, consult doctors or other professionals, and decide whether to participate in the experience purchase after confirming that their physical conditions permit. We should choose regular medical institutions. Consumers should be careful to participate in the free experience of medical devices. If they have diseases, they should choose regular medical institutions for treatment. They should not be greedy to save trouble and blindly listen to the propaganda of businesses, so as to avoid unnecessary health and property losses.

Xinshao: it will be a history for individual businesses to deal in drugs, class II and class III medical devices 2019-08-09

On August 6, the staff of Xinshao County Market Supervision Bureau went into the individual pharmacies under its jurisdiction to carry out the publicity and launch work of cleaning up the business qualification of individual businesses engaged in the operation of drugs, class II and class III medical devices. The entire clean-up will continue until November 30, 2019. The purpose of this qualification clearance action is to comprehensively standardize the operation of drugs, class II and class III medical devices in Xinshao County, and to eliminate the phenomenon of individual businesses operating drugs, class II and class III medical devices. The Bureau will organize the drug equipment unit to find out the market subject qualification of the drug equipment retail business units in the whole county and establish a standing book, and then distribute the standing book to the administrative examination and approval unit and each supervision office. According to the division of responsibilities, the supervision offices, the administrative approval units and the drug and equipment units under the jurisdiction of Xinshao market supervision bureau cancel the individual business license, handle the enterprise business license and change the related matters of drug and equipment license. In November, the Bureau will clean up the qualification of market entities of drug and equipment retail business units in the whole county again, and standardize the market entities of individual drug and equipment business according to the requirements, so as to ensure that the regulation rate reaches 100%.

Registered medical device company? You need to meet these conditions 2019-08-09

Medical device industry involves medicine, machinery, electronics, plastics and other industries. It is a high-tech industry with interdisciplinary, knowledge intensive and capital intensive. It is an industry with rapid development in modern society. It is also a strategic emerging industry supported by the state. So how to register a medical device company in Shanghai? Next, Yu Shang Xiaobian will tell you something. Medical devices can be divided into three categories according to their risk degree, and the processing conditions of different types of medical devices are also different. Today, I will focus on the registration of class II medical device companies. First of all, the registration should have the conditions 1. It shall have a quality management organization or quality management personnel suitable for its business scope and scale, and the quality management personnel shall have relevant professional qualifications or professional titles recognized by the state; 2. It shall have business and storage sites suitable for its business scope and scale; 3. If the storage conditions are suitable for the business scope and scale, and all the medical devices are entrusted to other medical device business enterprises for storage, the warehouse may not be set up; 4. Have a quality management system suitable for the medical devices; 5. Have the ability of professional guidance, technical training and after-sales service corresponding to the medical devices, or agree to provide technical support by relevant institutions. Class II medical device company registration process is the same as the general company registration process, but there is an on-site inspection and filing process. About the filing of class II medical devices. Class II medical devices refer to those with moderate risk, which need strict control and management to ensure their safety and effectiveness. According to the regulations of the measures for the supervision and administration of the operation of medical devices, those engaged in the operation of class II medical devices shall file with the local municipal food and drug administration, fill in the record form for the operation of class II medical devices, and submit the following information: 1. Copy of business license; 2. Copies of the identity certificate, educational background or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of quality; 3. Description of organization and department setting; description of business scope and operation mode; 4. A copy of the geographical location map, plan of the address of the business site and warehouse, the certificate of the property right of the house or the lease agreement (with the certificate of the property right of the house attached); 5. Catalogue of business facilities and equipment; catalogue of business quality management system, working procedures and other documents; 6. Other supporting materials. The requirements for the area of the warehouse are different with the operation of medical devices. If the business is a disposable medical device enterprise for blood transfusion, infusion and injection, the warehouse area should not be less than 100 square meters (different regions have different policy requirements). If the enterprise is engaged in three types of medical devices, it needs to apply for a medical device business license. The term of validity of the medical device business license is 5 years. If the term of validity needs to be extended, the renewal procedures shall be handled in accordance with the relevant laws and regulations on administrative license. If a registrant fails to apply for renewal of registration within the specified time limit; the mandatory standards for medical devices have been revised, and the medical devices applying for renewal of registration can not meet the new requirements; if the medical devices used for treating rare diseases and dealing with public health emergencies are not completed within the specified time limit, the renewal of registration will not be allowed.

The 82nd China Medical Devices International Fair 2019-04-11

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