The National Medical Products Administration (NMPA) of China has released the results of its latest quality inspection of medical devices. The inspection, covering 17 categories of products, found 24 batches (units) that failed to meet the required standards on September 12, 2024.
Key findings include:
1. High-Frequency Electrosurgical Units: Two units, produced by Gebrüder Martin GmbH & Co.KG and a Chinese company, failed to meet standards for high-frequency leakage current and protection of radio services.
2. Intense Pulsed Light Therapy Devices: Two units, including one from ActiveOptical Systems Ltd., did not meet input power and pulse energy density requirements.
3. Pulse Oximeters: Three units from Chinese manufacturers failed accuracy tests.
4. Scar Repair Gel: One batch failed pH level standards.
5. Arthroscopes: A batch produced by ConMed Corporation did not meet color discrimination and light efficiency standards.
6. Soft Contact Lenses: One batch from a Taiwanese company failed to meet base curve radius standards.
7. Hydrocolloid Dressings: Batches from Paul Hartmann AG and a Chinese company did not meet liquid absorption standards.
8. Medical Protective Masks and Protective Clothing: Batches from Chinese manufacturers failed filtration efficiency and antistatic property tests respectively.
The NMPA has instructed provincial authorities to take appropriate administrative actions against the non-compliant products. Companies are required to conduct risk assessments, initiate product recalls if necessary, and implement corrective measures.
This inspection highlights the ongoing efforts of Chinese regulators to ensure the quality and safety of medical devices in the market, affecting both domestic and international manufacturers.