Recent Enforcement Actions in China’s Medical Device Sector Highlight Regulatory Compliance
China's National Medical Products Administration has recently disclosed details of six typical cases of illegal activities in the medical device sector on 25 April 2024. These cases highlight the government's ongoing efforts to enforce strict regulations to ensure the safety and legality of medical device operations. Here are the key points from each case:
1. Shanghai Youya Pharmaceutical Technology Co., Ltd. was fined for producing Class II medical devices without the necessary registration certificate and production license. During an inspection on February 2, 2023, it was found that the company manufactured "Medical Sodium Hyaluronate Repair Patches" illegally, leading to a fine and confiscation of illegal gains totaling over 391,000 yuan.
2. Changchun Aiden Dental Technology R&D Co., Ltd. faced penalties for discrepancies between the registered and actual manufacturer names on the packaging of their Class II medical devices, specifically custom dental prosthetics. The inspection on June 15, 2023, resulted in a 40,000 yuan fine.
3. Erdos Liankang Trade Co., Ltd. was sanctioned for dealing in unregistered Class II medical devices, specifically "Pulse Oximeters," without proper procurement and inspection records. The company was fined and had illegal gains confiscated on September 26, 2023, after an inspection initiated from a tip-off.
4. Suzhou Taodongkang Trade Co., Ltd. was caught submitting false information during the business filing for Class II medical devices. An investigation on July 31, 2023, revealed falsified personal details for the legal representative and quality manager, resulting in a 20,000 yuan fine.
5. Chongqing Hexi Medical Beauty Clinic was heavily fined for using unregistered and expired medical devices, including a Class III "Electro-optic Q-switched Laser" and "M22 Intense Pulsed Light" equipment. A joint enforcement inspection on July 26, 2022, led to corrective actions and a substantial fine of 8.34 million yuan.
6. Yuanyang County Traditional Chinese Medicine Hospital was penalized for using expired medical devices, such as the "α-Hydroxybutyrate Dehydrogenase Test Kit." An inspection on September 20, 2023, resulted in the confiscation of expired products and a fine of 56,864 yuan.
These cases underscore China's commitment to rigorous enforcement of medical device regulations to protect public health and safety.