China medical device supervision inspection results were announced by China’s National Medical Products Administration (NMPA) on November 14, 2023. The results revealed that a total of 11 different categories of medical devices and 20 batches of products did not meet the required standards. The announcement provides details of the findings and the actions being taken.
I. Non-Compliant Medical Device Products:
- Anesthesia Machines and Respirators’ Breathing Circuits (1 batch):
- manufacturer: Nanchang Beiot Medical Technology Co., Ltd.
- non-compliance: lack of conformity to standard requirements.
- Soft Contact Lenses (3 batches):
- manufacturers: medios Co., Ltd., DUEBA Contact Lens, and ICK Co., Ltd.
- non-compliance: light transmittance does not meet standard requirements.
- Adhesive Medical Devices (Far Infrared Treatment Patches, Magnetic Therapy Patches, Acupoint Magnetic Therapy Patches) (6 batches):
- manufacturers: various companies including Anhui Jinyang Biological Technology Co., Ltd. and Shenzhen Duyi Biotechnology Co., Ltd.
- non-compliance: detection of drug components that should not be present according to supplemental inspection methods.
- Disposable Sterile Surgical Membranes (1 batch):
- manufacturer: Jiangxi 3L Medical Products Group Co., Ltd.
- non-compliance: lack of sterility compliance with standards.
- Medical Radiation Protective Equipment (1 batch):
- manufacturer: Shandong Kaka Medical Products Co., Ltd.
- non-compliance: Dimensions do not meet standard requirements.
- Nd:YAG Laser Therapy Machine (1 unit):
- manufacturer: Sichuan Aerospace Shidu Guidance Co., Ltd.
- non-compliance: laser pulse width does not meet standard requirements.
- Electric Gastric Lavage Machines (3 units):
- manufacturers: Jiangsu Kelin Medical Equipment Co., Ltd., Tianjin Yaku Electronic Technology Development Co., Ltd., and Yangzhou Huike Electronic Co., Ltd.
- non-compliance: Flow rate, flush-suction switching device, and pressure limit do not meet standard requirements.
- Infusion Pumps (1 unit):
- manufacturer: Shanghai Lande Medical Equipment Co., Ltd.
- non-compliance: input power does not meet standard requirements.
- Electrocardiogram Machines (1 unit):
- manufacturer: Guangdong BaolaiTe Medical Technology Co., Ltd.
- non-compliance: Amplitude and interval measurement requirements do not meet standard requirements.
- Medical Oxygen Concentrator (1 unit):
- manufacturer: Hunan Tairui Medical Technology Co., Ltd.
- non-compliance: Oxygen concentration status indicator and time indicator do not meet standard requirements.
- Infant Phototherapy Equipment (1 unit):
- manufacturer: Foshan Liuxi Medical Technology Co., Ltd.
- non-compliance: input power, external markings of equipment or equipment components, distribution, and lifespan check do not meet standard requirements.
II. Actions Taken:
The NMPA has instructed the respective provincial Medical Product Administrations (MPA) to take administrative actions in accordance with the “Regulations on the Supervision and Management of Medical Devices,” the “Measures for the Supervision and Administration of Medical Device Production,” and the “Measures for the Administration of Medical Device Recalls,” among other relevant regulations. Companies are required to promptly announce these actions to the public.
The provincial MPAs will oversee the risk assessment of non-compliant products and determine recall levels based on the severity of medical device defects. Companies are urged to proactively recall products and publicly disclose recall information. Additionally, companies must promptly investigate the reasons for product non-compliance, formulate corrective measures, and ensure timely implementation.
This is a crucial reminder of the importance of adherence to regulatory standards in the medical device industry. Regulatory affairs professionals are encouraged to stay informed and engaged in ensuring the highest standards of quality and safety in their respective roles.
Further information
For specific details regarding the non-compliant products, please refer to the original NMPA announcement here.
Read our previous article on China medical device sampling inspection – September 2023 notice on failure of compliance.
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