China NMPA Reports 6 Cases Of Illegal Online Sales Of Medical Devices

On December 5th , the National Medical Products Administration (NMPA) has guided local drug regulatory authorities to intensify monitoring and crack down on illegal activities through the National Medical Device Online Sales Monitoring Platform. This initiative aims to protect public health and ensure the safety of medical equipment.

1. Unauthorized Sale of Class III Medical Devices by a Pharmacy Online Sales

The Market Supervision Administration, based on monitoring clues from the National Medical Device Online Sales Monitoring Platform, conducted on-site inspections of a pharmacy. It was revealed that the pharmacy, lacking the required operating license, sold Class III medical devices such as insulin injection pen needles on the platform without updating the display of the medical device registration certificate. The Market Supervision Administration imposed administrative penalties in accordance with relevant regulations.

2. Unauthorized Sale of Class III Medical Devices by a Company Online Sales

Following monitoring clues, the Market Supervision Administration conducted on-site inspections of a company. The company was found to be selling Class III medical devices, specifically sterile Vaseline gauze, without obtaining the necessary medical device operation license. The Market Supervision Administration issued administrative penalties in accordance with the relevant regulations.

3. Illegal Sale of Unregistered Class II Medical Devices by a Company Online Sales

Acting on a tip-off, the Market Supervision Administration inspected a company and discovered the illegal sale of unregistered Class II medical devices, specifically an IPL pulsed light hair removal device on an e-commerce platform. Administrative penalties were imposed in accordance with regulations.

4. Sale of Decertified Medical Devices by a Company Online Sales Without Compliance

The Market Supervision Administration, based on monitoring clues, inspected a company selling a Class I medical device, the micro-needle, which had been decertified. Despite being ordered to rectify the situation, the company failed to comply within the stipulated period. Administrative penalties were imposed in accordance with regulations.

5. Online Sales of Medical Devices Without Displaying Class II Medical Device Operation Record Certificate

The Market Supervision Administration, based on monitoring clues, inspected a company selling second-class medical devices, including a surgical shadowless lamp, without displaying the required operation record certificate. Additionally, the displayed medical device registration certificate did not match the products sold. Administrative penalties were imposed in accordance with regulations.

6. Online sales of Medical Devices by a Drug Retail Company Without Displaying Medical Device Registration Certificate

The Market Supervision Administration conducted on-site inspections of a drug retail company selling blood glucose meters and medical alcohol disinfectant cotton pads online. The company failed to display the medical device registration certificate and did not rectify the situation within the specified time frame. Administrative penalties were imposed in accordance with regulations.

Safety Advisory for Online Medical Device Purchases:

According to the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of the Operation of Medical Devices, entities engaged in the operation of medical devices must not handle unregistered, unrecorded, or expired medical devices without proper certification documents. Medical device businesses are urged to enhance their awareness of legal compliance. Third-party platforms facilitating online medical transactions are required to continuously strengthen compliance governance, monitor and manage the qualifications of medical device operators and their products, and promptly report any illegal activities to local drug regulatory authorities.

Health authorities emphasize their commitment to the strictest standards, intensifying supervision efforts, and imposing severe penalties for illegal activities to ensure the safety of medical devices and protect the public.

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