Is it okay for two medical device companies to have their registered addresses together?

1) Have quality management that is compatible with the scope and scale of business.

Institutions or quality management personnel, quality management personnel shall have relevant professional qualifications or professional titles recognized by the state;

2) Have a business and storage place that is compatible with the scope and scale of business;

3) With storage conditions suitable for the scope of business and business scale, all entrusted to other medical device business enterprises for storage may not set up a warehouse;

4) Have a quality management system that is compatible with the medical devices operated.

5) Have the ability of professional guidance, technical training and after-sales service suitable for the medical devices operated, or agree to provide technical support by relevant institutions.

Enterprises engaged in the operation of Class III medical devices shall also have a computer information management system that meets the requirements of medical device operation quality management to ensure that the products operated can be traced. Encourage the engagement of Class I and Class II medical devices.

The operating enterprise shall establish a computer information management system that meets the requirements of medical device operation quality management.

Enterprises must have their own business premises, and they cannot share the same place.

Okay. A good place is where peers gather.

Generally, it can be transferred if it is permitted by law.

The basic ones are to meet the following criteria for this hole and the following certificates.

First of all, according to Article 18 of the Measures for the Supervision and Administration of Medical Device Production, medical device manufacturers that have been cohesively leased due to division and merger shall apply for cancellation of the Medical Device Production License.

Newly established medical production enterprises due to the division or merger of enterprises shall apply for the "Medical Device Production License".

Under special circumstances, it may not be transferred: the Food and Drug Administration is looking at the manufacturer of the listed product, and the model structure of the product should be the same as the information of the registration certificate, and the production address of the registration data should be consistent with the actual production address.

Hope mine is helpful to you!

Generally, it can be transferred if it is permitted by law.

The basic ones are to meet the following standards and the following certificates.

First of all: according to Article 18 of the Measures for the Supervision and Administration of Medical Device Production, medical device manufacturers that survive due to division and merger shall apply for cancellation of the Medical Device Production License; Newly established medical production enterprises due to the division or merger of enterprises shall apply for the "Medical Device Production License".

Under special circumstances, it may not be transferred: the Food and Drug Administration looks at the manufacturer of the listed product, and the model structure of the product should be the same as the information on the registration certificate.

I hope my scramble answer is helpful to you!

The three mentioned in the question are only different industries, and the difference is not big, it is recommended to choose medical technology, which sounds more atmospheric.

The medical device industry is a high-tech industry involving medicine, machinery, electronics, plastics and other industries, and is a multidisciplinary, knowledge-intensive and capital-intensive high-tech industry.

The basic characteristics of high-tech medical equipment are digitalization and computerization, which is the crystallization of modern high technology across disciplines and fields, and its products have high technical content and high profits. From some perspectives, medical devices represent the technological level and strength of a country's medical industry.

What are the requirements for a registered medical device company? You must be aware of these processes and costs!

As a special management commodity, the registration of medical devices is an administrative licensing matter.

Class I medical devices (including domestic and imported) are subject to filing management.

Class II and Class III medical devices (including domestic and imported) are subject to registration management. Handle the filing and application of Class II medical device products for Class I.

For the registration of Class III medical device products, the following materials shall be submitted: product risk analysis data; product technical requirements; Product inspection report; clinical evaluation data; Samples of product manuals and labels; Quality management system documents related to product development and production; Other documents required to prove the safety and effectiveness of the product.

So what are the conditions for a registered medical device company? You must be aware of these processes and costs!

Yes. 1. No license and filing are required for the operation of Class I medical devices, and no license and filing are required for the operation of Class I medical devices. However, those engaged in the operation of Class I medical devices shall meet the following requirements:

First, it should have business premises and storage conditions that are compatible with the scale of operation and the business scope of Biji. Second, it has a quality management system and quality management institutions or personnel that are compatible with the medical devices it operates.

Second, the operation of the second class of medical devices to implement record management.

3. The operation of Class III medical devices shall be subject to license management.

Enterprises operating Class III medical devices shall meet the following requirements: First, they shall obtain a medical device business license. Second, it should have a computer information management system that meets the requirements of medical device management quality management to ensure the traceability of operating products.

Third, it is necessary to establish a sales record system and a quality management self-inspection system.

The sale of medical devices must be registered company, and there must be a medical device business license, the certificate is a medical device business enterprise must have the certificate, the first class of medical device business enterprises, should be filed with the provincial, autonomous region, municipality directly under the Central Government's people's drug regulatory department; The establishment of Class II and Class III medical device business enterprises shall be reviewed and approved by the people's drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government, and issued with the "Medical Device Business Enterprise License". Without the "Medical Device Business Enterprise License", the administrative department for industry and commerce shall not issue a business license. The "Medical Device Business Enterprise License" is valid for 5 years.

To operate medical devices, you first need to apply for a medical device business license, and secondly, you need to apply for an industrial and commercial business license. The medical device business license has certain regulations for the site and personnel, so it is better to consult a professional medical device consulting company. 1.

According to the requirements of the State Bureau for on-site inspection and acceptance of medical device business enterprises, establish and improve the organizational structure of the enterprise, and assist the enterprise in training on medical device regulations and practical operation. 2.Inspect the existing hardware of the enterprise, and jointly formulate the hardware rectification plan and engineering design plan with the enterprise according to the requirements of the "National Medical Device Business Enterprise On-site Inspection and Acceptance Standards".

3.Install the software management system and assist the enterprise to complete the preparation of quality management system documents. 4.

Provide samples or templates of application materials to guide enterprises to complete the preparation of application materials. 5.Submit an application for license inspection to the drug regulatory department and follow up until the medical device business license certificate is obtained.

6.Handling of industrial and commercial business licenses. There may be some differences in the details of this requirement in different regions.

The most certain way is to directly find the ** of your provincial food and drug administration to find the relevant requirements. The general process is: confirm the category of equipment that needs to be operated--- determine whether to apply to the municipal bureau or the provincial bureau according to the different categories--- find the content required to submit by the operating company--- prepare materials according to the requirements--- submit the application --- approved.