Class II medical device license can be business scope

The Class II medical device license can operate in the scope of Class II medical devices, such as 6815 injection and puncture instruments, 6820 general diagnostic instruments, 6830 medical X-ray equipment, 6831 medical X-ray accessory equipment and components and so on. Generally speaking, the determination of this Class II medical device should be the first comparison of the medical device is the existence of the type of regulation inside. That is to say, the scope of business is the regulation inside the Class II medical equipment.

Engaged in the second class of medical equipment business, business enterprises should be located in the municipal food and drug supervision and management department for the record, fill out the second class of medical equipment business filing form.

Now in Taobao, Tmall, Jingdong and other e-commerce platforms to open a store to sell Class II medical devices, you have to first apply for Class II medical device business filing vouchers, and then for the record of network sales.

Since June 1, 2014, engaged in the operation of Class II medical devices, operating companies should fill out the Class II medical device business filing form to the location of the municipal food and drug supervision and management department for the record, and submit the filing materials in line with the requirements of the Class II medical device business filing materials.

Receiving medical device business filing materials, municipal food and drug supervision and management departments should be field on the integrity of the filing materials for verification, in line with the prescribed conditions to be filed, issued by the second class of medical equipment business filing vouchers).

Legal basis:

"Regulations for the Supervision and Administration of Medical Devices"

Article 16 Application for registration of Class II medical device products, the applicant for registration shall be to the seat of the provincial, autonomous regions, municipalities directly under the Central People's Government of the People's Government of the drug supervision and management department to submit an application for registration information. Apply for registration of Class III medical device products, the applicant shall submit an application for registration to the State Council Drug Administration.

To China's exports of Class II, Class III medical devices outside the applicant for registration, by its designated enterprise legal person in China to the State Council Drug Administration to submit the application for registration and registration of the applicant's country (region) competent authorities to permit the marketing of the medical device supporting documents. Not in the overseas market of innovative medical devices, can not submit the registration applicant's country (region) competent authorities to authorize the marketing of the medical device documents.

The State Council Drug Administration shall review the medical device registration procedures and requirements, and strengthen the provincial, autonomous regions and municipalities directly under the Central People's Government of the drug supervision and management department of the supervision and guidance of the registration review work.