Draft Revision to the Good Manufacturing Practice for Medical Devices

Quality Department, Suzhou Jinxie Medical Device Factory · February 12, 2025

New Transformations in the Regulations

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Revision to Medical Device Regulations

The "Good Manufacturing Practice for Medical Devices (Draft Revision for Public Comment)", released on January 15, 2025, shows significant changes compared with the 2014 version. This revision aims to strengthen the whole-lifecycle supervision, clarify the main responsibilities of enterprises, and promote the development of the medical device industry towards a higher level of specialization and standardization. Next, let's take a closer look at the main changes.

01 The Changes in Structure and Length

This revision includes some obvious adjustments to structure and length. The number of chapters and clauses has increased significantly. The 2014 version has a total of 13 chapters and 84 clauses, equivalent to approximately 5,900 words, while the 2025 draft revision has expanded to 15 chapters and 131 clauses, equivalent to approximately 16,000 words, with three new chapters added: "Quality Assurance and Risk Management", "Verification and Validation", and "Outsourced Production and Sub - contracted Processing". Moreover, the clause of the new chapters is more substantial. For example, the original "Organization and Personnel" chapter further details the key job responsibilities, and new job requirements such as "Release Reviewer" have been added.

This adjustment to structure and length reflects a more comprehensive and in-depth consideration given to the quality management of medical device manufacture. The establishment of new chapters helps to focus on key links, and the substantial clause provides enterprises with more specific and clear operational guidelines, which is conducive to improving the quality and safety of medical device manufacture.

02 Updates on Key Contents

In terms of key contents, this revision shows many highlights. First, the scope of application for whole-lifecycle quality management clearly covers the entire process of design and development, production, sales, and after-sales service of medical device registrants, filers, and entrusted enterprises. It is emphasized that risk management should be practiced through the product lifecycle, and control measures should be adapted to the level of risk. Second, in terms of informatization and traceability requirements, enterprises are required to manage electronic records through an information system to ensure the authenticity and traceability of data, and to support the creation and implementation of Unique Device Identification (UDI) for medical devices. UDI management should cover production, circulation, and usage to strengthen product traceability.

In addition, the qualifications and responsibilities of personnel have also been enhanced. Regarding the representative managers, Class II and Class III enterprises are required to have a bachelor's degree or above in a medical device-related major, and Class I enterprises are required to have a junior college degree or above. The quality management director is required to have a bachelor's degree or an intermediate professional title and more than 3 years of work experience. The production management director is required to have a junior college degree and more than 3 years of work experience. At the same time, the requirement of "health record" has been added to manage the health of personnel who affect product quality. In terms of quality system and process control, a "change control procedure" has been added, the requirements on verification and validation have been strengthened, and the classified management of suppliers has been refined. In terms of facilities and environmental requirements, the factory building design should meet the cleanliness classification requirements, production equipment should have clear status identification, and inspection instruments should be calibrated regularly and their records should be retained.

03 Strengthening of Supervision and Compliance

The draft revision places higher requirements on the main responsibilities of enterprises. Enterprises need to establish quality objectives and continuously improve the quality system through various methods such as data monitoring, corrective actions, and management reviews. When production is outsourced, the principal shall supervise the entrusted party throughout the process to ensure the effective connection of the quality management system.

At the same time, the compliance and penalty mechanisms are also tightened. False and deceptive acts are clearly prohibited, with the principle of honesty and trustworthiness emphasized. The requirement of "quality risk review" has been added to regularly evaluate the effectiveness of risk control measures. These measures help to ensure the compliance of medical device manufacture and improve the overall quality level of the industry.

04 Significance and Impact of Implementation

This revision has an important significance for the whole industry. It aims to meet the needs of the medical device industry for high-speed development. By refining clauses, raising the threshold of entry, and strengthening whole-process supervision, it promotes the transformation of the industry towards specialization and standardization. For example, the increase in educational requirements may give rise to more professional positions, while UDI and information management will accelerate the process of digitizing the industry.

This series of changes will prompt enterprises to strengthen their own management and improve product quality, so as to better meet market demands and protect public health. For the entire industry, it will also promote the optimal allocation of resources while improving the competitiveness of the industry and its sustainable development.