Quality management of medical device business operations in China has a new draft regulation issued by the Center for Medical Device Evaluation (CMDE) under the National Medical Products Administration (NMPA) on June 1, 2023.
The current regulation for quality management of medical device business operations was issued in 2014, and has played a crucial role in standardizing medical device quality management, strengthening regulatory oversight, fostering high-quality industry development, and ensuring the safety and efficacy of medical devices used by the public. The NMPA initiated the revision process to align with the new requirements of the regulations on the supervision and administration of medical devices as well as the measures for the supervision and administration of medical device operations whilst addressing the evolving needs of medical device operation supervision and quality management.
In this blog post, we will summarize and highlight the key points of this draft regulation and its potential implications for businesses operating in the medical device industry in China.
Key points for quality management of medical devices business operations
- Total 9 chapters and 113 articles
- The draft regulation consists of 9 chapters and 113 articles that cover various aspects of medical device quality management, including the establishment and improvement of quality management systems, responsibilities and regulations, personnel training, and facility and equipment requirements.
- Refinement and supplement of existing requirements
- To address practical challenges in medical device operation, the draft regulation refines and supplements certain areas. This includes clarifications related to inspection and medical-related professions, expansion of the scope of self-inspection reporting by enterprises, and defining in-service and on-duty personnel. Additionally, the draft enhances enterprise and product qualification review and management, as well as after-sales service management. For instance, it specifies that enterprises must establish after-sales service management procedures, including complaint channels, recordkeeping, investigation and assessment, action plans, feedback, and post-follow-up procedures.
- Addressing New Business Models
- The draft regulation takes into account emerging business models and operational methods in the medical device industry. It introduces requirements for quality management in areas previously unaddressed, such as automatic vending machine quality management, direct sales quality management, management of products sold after clinical confirmation, and collaborative management of multiple warehouses. For the latter, the draft suggests that companies can establish warehouses across different administrative regions or entrust specialized companies to provide medical device transportation and storage services, creating a nationwide or regional collaborative logistics management model.
- Emphasis on Digital Transformation
- Recognizing the need for more efficient and streamlined regulatory processes, the draft regulation advocates for digital transformation in the medical device industry. It suggests that electronic certificates issued by relevant government departments carry the same legal effect as physical certificates. Moreover, the draft provides detailed requirements for the implementation of medical device unique identifiers in product acceptance, outbound verification, and computer systems, promoting the comprehensive implementation of such identifiers.
Read the original CMDE announcement on the draft regulation of quality management of medical device business operations in China which represents a significant step by the Chinese authorities to address the changing landscape of the medical device industry and enhance its supervision and quality management.
Businesses operating in the medical device sector in China are recommended to carefully review and analyze draft regulations and actively participate in public consultation processes. Engaging with the regulatory authorities allows businesses to voice their concerns, seek clarifications, and ultimately contribute to the formulation of regulations that promote safety, innovation, and sustainable growth in the industry.
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