What Should I Do before Starting a Business Selling Medical Devices in China?

Recently more foreign investors are choosing to invest in the distribution of medical devices in China. However, there are some standards and legal requirements in this field you need to know if you want to invest in this area.

Recently, our law firm received an advisory case regarding the license required for the sale of medical devices in China. After a complete explanation by our law firm, the client was satisfied with our solution.

We would like to take this opportunity to provide a complete and systematic introduction of the licenses that are needed to sell medical devices in China.

There are two steps that need to be aware while selling medical devices in China. Step 1, you need to confirm the specific category of the medical devices.

According to the Regulation on the Supervision and Administration of Medical Device (医疗器械监督管理条例) issued by the State Council of China, the medical devices sold in China are managed in three categories. The PRC National Medical Products Administration (hereinafter the “NMPA”) has made detailed divisions based on the risk classification of medical devices and issued industry standards for the safe management of medical devices. The higher level at which the medical device is classified means the greater their risk, which also means that they require more stringent regulation.

The following is the specific classification of the medical devices such as needles, syringes, coveralls, gloves and masks, which is listed in the Classification Catalog of Medical Devices (医疗器械分类目录) issued by the NMPA:

1. Regarding the management category of syringes, sterile syringes (such as disposable sterile syringes, disposable sterile auto-destruct syringes, and disposable low resistance syringes) and needle-less syringes are classified as the Third Category Medical Devices, pen-type syringes and all-glass syringes are classified as the Second Category Medical Devices.

2. Regarding the management category of needles, disposable sterile injection needles are classified as the Third Category Medical Devices, and disposable non-sterile injection needles are classified as the Second Category Medical Devices.

3. Regarding the management category of coveralls, medical protective clothing and disposable medical protective clothing are classified as the Second Category Medical Devices, medical protective clothing is the occupational protective clothing for medical staff in medical institutions, which is used to prevent the spread of virus from patients. Isolation clothing is classified as the First Category Medical Devices, isolation clothing is used for general isolation of outpatient, ward, and laboratory in medical institutions.

4. Regarding the management category of gloves, sterile medical rubber gloves and sterile medical film gloves are classified as the Second Category Medical Devices, medical rubber gloves and medical film gloves are classified as the First Category Medical Devices.

5. Regarding the management category of masks, medical masks are classified as the Second Category Medical Devices.

After confirmed the categories of the medical devices you are going to sell according to the above contents, then here comes Step 2: you need to confirm the requirements you shall meet to sell different categories of medical devices in China.

According to the Regulation on the Supervision and Administration of Medical Devices (医疗器械监督管理条例) issued by the State Council of China:

1. When a company sells the First Category Medical Devices, the medical devices it sells shall be filed and be put on record at the Food and Drug Administration Department of the city where the selling company is located.

2. When a company sells the Second Category Medical Devices, the medical devices it sells shall be registered at the Food and Drug Administration Department of the province where the selling company is located, and the selling company shall submit materials to the Food and Drug Administration Department of the city where the selling company is located for the record, proving that it has the address, storage conditions, quality management system and quality management personnel suitable for the sale of medical devices.

3. When a company sells the Third Category Medical Devices, the medical devices it sells shall be registered at the PRC National Medical Products Administration, and the selling company shall apply to the Food and Drug Administration Department of the city where the selling company is located for a sales license, and submit materials to the Food and Drug Administration Department of the city where the selling company is located, proving that it has the address, storage conditions, quality management system and quality management personnel suitable for the sale of medical devices.

To sum up, it is important to confirm the specific management category of the medical devices you are going to sell. Then you need to file, register, and apply for sales license according to the requirements of selling different management categories of medical devices.

The above is our collation of the relevant provisions of the sale of medical devices. If you have any questions on the legal requirements of entering a business selling medical devices in China, please feel free to contact our professional Chinese lawyers.