The latest China medical device inspection results were published by the National Medical Products Administration (NMPA) on September 11, 2024. A medical device inspection is undertaken to ensure the safety and effectiveness of a medical device that is placed on the market. This inspection round covered 17 product varieties including semiconductor laser therapy machines, scar repair gels, high-frequency scalpels, and more. Both domestic and foreign manufacturers’ products were sampled. Of the sampled products, 24 batches (or units) did not meet the required regulatory standards. Below is a breakdown of the findings and implications for manufacturers and regulatory affairs managers.
Medical Device Inspection Key Findings:
Semiconductor Laser Therapy Machine:
- One batch from Nanjing Yigao Medical Technology Co., Ltd. was found non-compliant, specifically in terms of laser readiness indicators, standby features, and remote control interlock connectors.
High-Frequency Scalpel:
- Two batches from Gebrüder Martin GmbH & Co. KG and Nanjing Shoumei Medical Technology Co., Ltd. exhibited failures related to leakage current protection at normal operating temperatures and radio operation standards.
Intense Pulsed Light Therapy Instrument:
- Two batches from Adif Photonics Ltd. and Gu’an Next Light Technology Co., Ltd. showed deficiencies in input power and pulse energy density.
Medical Molecular Sieve Oxygen Concentrator:
- One batch from Baoding Meizhuo Medical Equipment Co., Ltd. failed to meet standards concerning continuous leakage current, as well as patient auxiliary current safety.
Medical Pulse Oximeters:
- Three units produced by Hunan Guojian Medical Devices, Shanghai Berry Electronic Technology, and Chongqing Ruotai Technology exhibited failures in pulse rate accuracy and signal integrity.
Syringe Pumps:
- Two units from Nanjing Inmani Medical Technology Co., Ltd. and Shenzhen Maketian Biomedical Technology Co., Ltd. did not meet alarm requirements, specifically regarding audible alarm signals.
Scar Repair Gel:
- One batch from Jiangsu Seeking Harmony Medical Devices Co., Ltd. failed to meet the regulatory standards.
Arthroscope:
- A batch from ConMed Corporation showed non-compliance in color discriminatory ability, color reproducibility, and light effect comprehensiveness.
Lithotripsy Baskets:
- Two batches from Guangdong Province Tianyou Medical Equipment Technology Development Co., Ltd. did not meet specified standards.
Soft Contact Lenses:
- One batch from Falcon Technology Co., Ltd. was found deficient in base arc radius and sagittal height.
Hydrocolloid Dressings:
- Two batches from Paul Hartmann AG and Guangdong Body Health Medical Technology Co., Ltd. failed liquid permeability tests.
Plaster Medical Devices:
- One batch from Chongqing Hao Ai You Pharmaceutical Technology Co., Ltd. showed the presence of unspecified pharmaceutical components.
Thrombus Suction Catheters:
- One batch from Guangzhou Yijie Medical Technology Co., Ltd. did not meet ultraviolet absorbance standards.
Medical Protective Masks:
- One batch from Hubei Changdi Medical Technology Co., Ltd. failed to meet standard requirements for medical masks.
Medical Disposable Protective Clothing:
- One batch from Hunan Yongfei Special Protective Products Co., Ltd. did not comply with anti-static standards.
Orthodontic Wires:
- One batch from Hangzhou Xihu Bio-materials Co., Ltd. showed deficiencies in yield bending force and stiffness compliance.
Lipoprotein (a) Determination Kit:
- One batch from Ningbo Botai Biotechnology Co., Ltd. did not meet the required standards.
Regulatory Actions following a Medical Device Inspection:
Provincial drug supervision departments are tasked with enforcing the recall and rectification processes for non-compliant products.
- Manufacturers must assess the risks associated with the defective products, determine recall levels based on the severity of defects, and initiate recall procedures promptly.
- Public announcements and corrective measures should also be undertaken by the companies.
- Manufacturers are also required to investigate the causes of non-compliance and implement corrective actions within specified timelines.
Regulatory managers with products registered in China should closely monitor these developments, ensure compliance with Chinese medical device regulations, and take proactive measures in the event their products are listed or found non-compliant in similar inspections.
Recommendations to avoid failing a medical device inspection in China
To navigate the complex regulatory landscape of the Chinese medical device market, the following recommendations are proposed to avoid failing a medical device inspection in China:
- Engage with Local Regulatory Compliance Experts: Collaborating with reputable regulatory compliance firms that specialize in Chinese medical device regulations can provide invaluable insights and guidance. Such experts can assist in interpreting complex regulations, ensuring that all product aspects—from design to labeling—meet Chinese standards.
- Regular Internal Audits: Implement systematic internal audits to assess compliance levels across all operational facets. These audits should scrutinize manufacturing processes, documentation, labeling, and post-market surveillance activities.
- Enhance Quality Management Systems (QMS): Align your QMS with both international standards and specific Chinese requirements. This dual alignment ensures broader compliance and facilitates smoother market operations.
By adhering to these recommendations, medical device manufacturers can better position themselves to meet Chinese regulatory expectations, ensuring sustained market access and safeguarding their corporate reputation.
Further information:
Read the original announcement on China Medical Device Inspection Results published by the NMPA.
Read our previous article on China medical device sampling inspection plan 2024.
Contact Cisema if you would like to learn more about our services for NMPA inspections and QMS adaptation.
