The third batch of Illegal and non-compliant medical device online sales were reported by the National Medical Products Administration (NMPA) on August 4, 2023.
China medical device online sales are tightly regulated to ensure the safety and efficacy of products, a practice governed by laws such as the “Regulations for the Supervision and Administration of Medical Devices” and “Measures for the Supervision and Administration of Medical Device Business.”
The NMPA is now further guiding local Medical Products Administration departments to strengthen the monitoring of online sales of medical devices. They rely on a national medical device online sales monitoring platform to keep track of sales and eliminate illegal activities. Despite these stringent measures, cases of violations still occur. Below are six such cases from 2023 that highlight the critical need for ongoing vigilance of China medical device online sales.
1. Zhou Yang Adult Health Care Supplies Store
On April 12, 2023, the Market Supervision and Administration Bureau in Jiangbei District discovered that this store was selling Class III medical devices without a proper business license on the Meituan Drug Buying Platform.
2. Zhongshan Yimei Electronic Technology Co., Ltd.
On May 26, 2023, following reported clues, Zhongshan City authorities found that the company was selling unregistered Class II medical devices, specifically “laser hair removal instruments,” on Pinduoduo Mall.
3. Hangzhou Dizun Medical Technology Co., Ltd.
On February 27, 2023, an inspection revealed that Hangzhou Dizun Medical Technology Co. was selling unregistered Class II “Fibeijin Lk87 oximeters” on Pinduoduo Mall.
4. Ningbo Jideng Electronic Technology Co., Ltd.
Ningbo Zhenhai District Market Supervision Bureau found on February 28, 2023, that Ningbo Jideng Electronic Technology Co. was selling unregistered Class II “Dayshow ice skin beauty instruments” on Tmall Mall.
5. Fureitang Pharmacy
On March 28, 2023, authorities in Harbin City, Nangang District discovered that Fureitang Pharmacy did not display its medical device business record certificate while selling “medical surgical masks” on its WeChat applet shop. The business failed to rectify the issue even after receiving a warning.
6. Shanghai Bosun Supermarket
Shanghai Hongkou District officials, on March 24, 2023, noted that Shanghai Bosun Supermarket was selling “medical ordinary masks” on the Hungry platform without displaying the required medical device registration certificate.
These violations signify a critical need for more robust enforcement of laws governing the online sale of medical devices. Manufacturers, distributors, and third-party platforms must recognize their primary responsibility for ensuring that every medical device sold complies with regulations.
The NMPA and other regulatory bodies are putting rigorous systems in place to monitor online sales and crack down on illegal activities.
With the plethora of distributors and increasing use of online sales platforms, it is an even greater challenge for overseas manufacturers to ensure their products are sold in accordance with the regulations in place to safeguard consumer health. Filing and registering medical devices through independent NMPA legal agents such as Cisema, means you retain full control of your products at all times. Contact us to find out more.
Read the original NMPA announcement on third batch of Illegal and non-compliant medical device online sales reported in 2023.
Read our article on the previous batch of non-compliant cases reported in June 2023.