New Regulations Issued:A Fine Of 50,000 Dollars And Revocation Of License For Repeated Use Of Disposable Medical Devices

According to the newly revised Regulations on the Supervision and Administration of Medical Devices released on June 1, 2021, NMPA will further strengthen regulatory measures, including prohibition of the import of expired, invalid, obsolete and used medical devices in any other forms.

Furthermore, the revised regulations require to increase punishment and cost of illegal activities, and place responsibility and punishment on individuals. The person in charge shall be confiscated of the income obtained from the entity during the period when the illegal act is committed, and shall also be fined not less than 30 percent but not more than three times the income obtained. If the circumstances are serious, the relevant entities shall be fined nearly 300,000 yuan, or 50,000 dollars, and be revoked their practicing license. In this news, we mainly focus on the relevant provisions of disposable medical devices.

Based on the regulations, the following behaviors will be punished.

• For the medical devices that are repeatedly used, the medical institutions fail to deal with them according to the disinfection and management regulations;
• The medical institutions reuse the disposable medical device, or fail to destroy the used disposable medical device according to the regulations.

As for disposable medical devices, especially high-value consumables, many foreign countries have reported that disposable medical devices can be reused after disinfection or sterilization. However, there is no relevant regulations to stipulate that disposable medical devices can be reused after disposal in China. Therefore, it’s important for overseas enterprises to pay attention to the new regulations and export the legal and compliant products to China.