Industry Leaders Applaud Revised Good Manufacturing Practice for Medical Devices as a Catalyst for Quality-Driven Upgrading

(Source: China Food and Drug Administration Network)

China Food and Drug News (Reporter Jiang Hongyu) — On November 4, the National Medical Products Administration (NMPA) released the newly revised "Good Manufacturing Practice for Medical Devices" (hereinafter referred to as the "Practice"). This aims to implement the provisions of the "Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Drug and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry," as well as the "Regulations on the Supervision and Administration of Medical Devices" and the "Measures for the Supervision and Administration of Medical Device Production." It provides a comprehensive update to the current 2014 version of the Practice. The Practice integrates the current status and characteristics of China's medical device industry in recent years, draws on international regulatory experiences in medical devices, systematically refines relevant requirements, and expands the content to 15 chapters with 132 articles.

"The Norm" is the basic criterion for quality management in medical device production and also serves as a standard and tool for drug regulatory authorities to carry out their supervisory duties. Lin Senyong, President of the Shanghai Yangtze River Delta Medical Device Industry Development Promotion Association, stated that in recent years, China's medical device industry has developed rapidly. "The Norm" keeps pace with industrial development, deeply integrates advanced international regulatory experiences, and will lead the industry into a new stage of development, injecting strong momentum into the continuous and healthy growth of the sector.

Guangdong Provincial Drug Administration's Director of the Medical Device Supervision Department, Guangyu Zhao, believes that this revision focuses on hot issues such as contract manufacturing, digital and intelligent transformation, quality by design, and risk-based lifecycle quality management concepts. It refines management standards for various scenarios to ensure regulatory requirements can adapt to industry development trends, enhancing the operability of the "Regulations" and further clarifying regulatory requirements, providing clear guidance for regulators.

Guided by new concepts and supported by practical measures

The new version of the "Regulations" has added dedicated chapters on quality assurance, verification, and validation, further strengthening quality management requirements in all aspects to ensure a high level of safety throughout the entire lifecycle.

"The Specification" significantly strengthens the systematic requirements for quality assurance capabilities." ShanghaiUnited ImagingWang Shumei, Vice President of Shanghai United Imaging Healthcare Co., Ltd. (hereinafter referred to as United Imaging), found that the chapter on quality assurance elaborates in detail the requirements for a quality assurance system that enterprises should establish, which will strongly promote the construction of quality management systems across the entire industry. For instance, it explicitly requires companies to establish quality objectives that comply with medical device quality management standards, transforming abstract quality policies into concrete action guidelines. This drives enterprises to integrate quality management requirements throughout all stages from design and development to after-sales service, providing a basis for internal supervision and performance evaluation.

Zhao Xi, Senior Director of Quality and Regulatory Affairs at Shanghai MicroPort Medical (Group) Co., Ltd. (hereinafter referred to as MicroPort), noted that the "Regulations" comprehensively embed the concept of risk management and apply it throughout the entire process of design and development, procurement, production, quality control, and analysis and improvement. He pointed out that "risk management" is mentioned nearly 20 times in the "Regulations," with "risk" appearing over 30 times. Relevant clauses emphasize the core role of "quality assurance and risk management" throughout the product lifecycle. This guides companies to adopt a risk-based approach, achieving "precise measures" in quality management and fundamentally enhancing the suitability and effectiveness of the quality management system.

"The emphasis on the concept of 'quality by design' is also a major highlight of the Regulations," said Zhao Guangyu. He pointed out that the Regulations strengthen the requirements for quality management activities in the crucial design and development phase of industrial development. To further emphasize the importance of verification and validation, the Regulations consolidate relevant clauses previously scattered across multiple chapters, add a new chapter titled "Verification and Validation," and integrate verification and validation throughout the entire product lifecycle, including design and development, technology transfer, and post-market surveillance.

"The Specification" provides not only macro-level guidance but also practical implementation pathways. Zhu Dehong, Director of the Licensing and Registration Department of Anhui Provincial Drug Administration, believes that "The Specification" indicates that enterprises should utilize a series of quality risk management methods such as quality data monitoring and corrective and preventive actions to guide companies in making more effective and consistent decisions in product development and production quality management. This will help achieve robust product design, production control, and ensure product quality and safety.

The "Regulations" clearly list the scope of key personnel positions in the chapter on "Institutions and Personnel," and systematically define the qualifications and core responsibilities for key positions such as the legal representative of the enterprise, principal officers, management representatives, and heads of production departments. In the view of Zhai Xiaohui, Director of the Medical Device Production Supervision Department of the Beijing Municipal Drug Administration, this measure solidifies the foundation of responsibility for "key positions," constructs a clear, seamlessly connected chain of responsibility, ensures accountability for each link in the quality management system, and effectively plugs management loopholes.

Using New Tools to Solve New Problems

Experts believe that the "Regulations" keep pace with the times, effectively integrating new concepts, new tools, and new systems of medical device quality management into the quality system management, providing strong support for solving new problems and serving the high-quality development of the medical device industry.

In recent years, the entrustment of medical device production has become increasingly active, optimizing resource allocation and promoting research and innovation while also presenting new challenges for regulatory work. The "Regulations" have established a separate chapter for entrusted production and outsourced processing, clarifying requirements regarding quality agreements for entrusted production, assessment and supervision of the entrusted party's capabilities, and change control. In this regard, Lin Senyong pointed out that the "Regulations" address previous regulatory gaps, establishing a closed-loop management system covering the entire product lifecycle to ensure high standards of product quality.

With the rapid development of the industry, a large number of new concepts have emerged, which must be precisely defined using scientific methods. The "Regulations" have made terminology a key focus of the revision, adding specific clauses to provide detailed introductions for 26 terms. "This gives industry professionals a clearer understanding of previously ambiguous technical terms," Zhu Dehong illustrated. For example, the definition of "data" in the "Regulations" covers information generated during activities such as the design and development, production, and sales of medical devices that reflects the execution of these activities. This includes text, numbers, symbols, barcodes, etc., breaking through the traditional perception that "data equals numerical values" and expanding its meaning and scope.

Alignment with international standards is also one of the highlights of the "Specification." Zhao Xi pointed out that the "Specification" incorporates international standards and advanced concepts from international organizations, such as ISO13485:2016 "Medical devices – Quality management systems – Requirements for regulatory purposes" and the new EU Medical Device Regulation (MDR). It is more consistent with globally widely applicable document requirements, such as those in the Global Harmonization Task Force (GHWP) guidelines. This facilitates the export of products by domestic companies, helps foreign companies importing products to understand and implement the requirements, and aids in the globalization of enterprises.

In recent years, new management methods such as intelligent production and information-based management have been widely applied in corporate practices. The "Regulations" encourage enterprises to advance digital and intelligent transformation, improve the efficiency of production and quality management, and promote high-quality industrial development. In this regard, Zhai Xiaohui said: "The 'Regulations' make clear requirements for information systems, software validation, electronic records, and data management, providing a system guarantee for enterprises' digital and intelligent transformation. This will boost operational efficiency, strengthen quality traceability capabilities, and offer significant support for enhancing international competitiveness."

The "Regulations" provided a nearly one-year transition period. "Down-to-earth and implementable" was Wang Shumei's evaluation. In her view, China has a large number of medical device companies with varying levels of quality management systems. Providing a longer transition period allows companies to conduct systematic training at ease, deeply understand the meaning of the clauses, comprehensively analyze the current situation and gaps, and formulate implementation plans, offering strong support for the industry to achieve high-quality compliance transformation.

Quickly Enter the "Upgrade" Work Status

Although the "Regulations" will not come into effect until November 1, 2026, many companies have quickly entered a state of work "upgrade," actively preparing for training, digital transformation, and other matters.

Zhao Xi believed that this was an opportunity to practice internal skills: "MicroPort will develop training courses in a tiered manner for dissemination, while utilizing tools such as management reviews and internal audits to promptly identify and rectify issues during the implementation process of the 'Regulations,' promoting a spiral improvement of the quality management system."

United Imaging will focus on strengthening the construction of a quality talent梯队. Wang Shumei introduced that the company will continuously conduct regulation interpretation and advanced capability training for key personnel such as management representatives and quality managers, ensuring the team possesses forward-looking risk control and complex problem-solving abilities.

Notably, MicroPort and United Imaging will leverage policy support to accelerate the deep application of information systems, enabling data to better support quality risk monitoring and management decision-making.

Not only are enterprises actively preparing, but provincial drug regulatory authorities are also deploying efforts to strengthen publicity and implementation while listing enhanced inspections and support, as well as accelerating regulatory alignment, as key priorities for the near future.

Zhu Dehong introduced that the Anhui Provincial Drug Administration will conduct "health checks" for enterprises. By focusing on inspecting personnel qualification requirements, electronic records, contract manufacturing and outsourcing processing, change management, etc., the administration will help enterprises summarize and analyze problems existing in the operation process, promptly take corrective and preventive measures, and carry out post-assessment. This will continuously form a closed loop of continuous improvement and accelerate the enhancement of the quality management system level.

Beijing Municipal Medical Products Administration Focuses on Promoting Full-Chain, Integrated Regulatory Coordination. Zhai Xiaohui stated that the administration will fully integrate the core requirements of the Regulation into the entire chain of medical device product registration verification, production license inspection, and post-market routine supervision. The focus is to implement a "unified standards, simultaneous inspection" model for registration and production license verification, promote information sharing across review, verification, and regulatory processes, and effectively enhance regulatory efficiency.

"The Guangdong Provincial Medical Products Administration will also strengthen supervision and inspection to reinforce the primary responsibility of enterprises. At the same time, the effective implementation of the new regulations relies on a professional team of inspectors, and we will focus on enhancing the capabilities of the regulatory team." Zhao Guangyu suggested that provincial drug regulatory authorities strengthen the construction of the inspector team, carry out systematic training and assessments, especially specialized training on key and difficult points of the 'Regulations,' to improve the professional standards and on-site inspection capabilities of the regulatory staff.

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(Editor: Guo Xiao)