Do medical devices need a license?

In recent years, the medical device industry has become more and more popular, and many investors want to develop in this area. So, what are the prerequisites for setting up a medical device company?

The "Medical Business License" is a must-have certificate for medical device business enterprises, and it is valid for 5 years.

Class I and Class II medical devices do not require a business license, but Class II medical devices need to be filed.

○ Class I Medical Device ○

Medical Equipment

What is a Class I Medical Device?

It is a medical device with low risk and safety can be guaranteed by routine management, such as: scalpel, surgical scissors, manual hospital bed, medical ice pack, cooling patch, etc.

Class I medical devices do not need to be licensed or filed, and only need to obtain a business license issued by the industrial and commercial department.

Class I

 ○ Class II medical device ○

Medical Equipment

What is a Class II medical device?

It is a medical device with moderate risk that requires strict control and management to ensure safety and effectiveness, such as: band-aids, thermometers, sphygmomanometers, oxygen concentrators, nebulizers, etc. It is necessary for the Municipal Food and Drug Administration to handle medical device operation records.

What information is required for Class II medical device filing?

1. Business license, official seal, company address documents

2. Legal person information

3. Information on the person in charge of the enterprise and the person in charge of quality

4. Staff roster

The management of Class II medical device business licenses has certain requirements for company qualifications, business premises, company employees, company quality management, medical product purchase channels, sales channels, and supervision.

Class II

 Solutions Consulting

Our company has rich experience in handling licenses. If you want to know more about import and export licenses, production licenses, food business licenses, etc., please contact SOLUTIONS!

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If you need any more information, feel free to contact SOLUTIONS. We will be glad to assist you.

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