The NMPA import suspension of SAMO SpA medical devices follows a recent remote off-site inspection by China’s National Medical Products Administration (NMPA). SAMO SpA is an Italian manufacturer specializing in medical devices. The focus of this inspection was on two of SAMO’s products:
- Trekking knee system – Registration Certificate No.: GuoXieZhuJin20173130169,
- Components of hip prosthesis – Registration Certificate No.: GuoXieZhuJin20153131744
Findings from the Inspection:
1. Inadequate Identification of Chinese Regulatory Requirements:
SAMO S.p.A. failed to effectively recognize and integrate specific Chinese regulatory mandates into their manufacturing and quality assurance processes. This oversight is critical, as understanding local regulations is paramount to ensuring product compliance and safety.
2. Product Technical Requirement (PTR) Errors:
The inspection uncovered inaccuracies in the parameter listed in the Product Technical Requirement. Accurate size is essential for the safe usage of medical devices and for maintaining transparency with regulatory bodies and end-users. The PTR is an integral part of the registration certificate which documents all standards to which a product must adhere. As a result of these deficiencies, the NMPA concluded that SAMO S.p.A. did not align with the standards outlined in China’s “Quality Management Standards for the Manufacture of Medical Devices” and its appendix concerning implantable medical devices.
Regulatory Actions Taken:
In response to these compliance issues and to safeguard public health, the NMPA has enforced the following measures, effective immediately:
- Suspension of Importation: The import of SAMO’s Trekking Knee System and Components of Hip Prosthesis into China has been halted.
- Cessation of Operations and Usage: All operations involving these products within China, including their usage in medical settings, are to be suspended.
These actions are in accordance with China’s “Supervision and Management of Medical Devices Regulations” and “Supervision and Management of Medical Device Production” guidelines.
Implications and Recommendations:
The repercussions of this regulatory decision are substantial for SAMO S.p.A., potentially affecting their financial standing, market reputation, and future business operations within China. This scenario serves as a cautionary tale for other medical device manufacturers about the critical importance of stringent compliance with local regulations. To navigate the complex regulatory landscape of the Chinese medical device market, the following recommendations are proposed:
- 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 NMPA import suspension announcement here.
Read our previous article on China GMP Medical Device 2022 Edition for Sterile and Implantable Devices.
Contact Cisema if you would like to learn more about our services for NMPA overseas factory inspections and QMS adaptation.
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