01 "Good Manufacturing Practice for Medical Devices"

        Recently, in order to strengthen quality management of medical device manufacturing, standardize manufacturing practices, promote standardized industry
development, and ensure the safety and effectiveness of medical devices for public use, the National Medical Products Administration revised the "Good Manufacturing
Practice for Medical Devices" according to relevant laws and regulations including the "Regulations on Supervision and Administration of Medical Devices" and the "Measures
for Supervision and Administration of Medical Device Production." The revised regulation will take effect on November 1, 2026. The original announcement issued by the China
Food and Drug Administration titled "Announcement on the Good Manufacturing Practice for Medical Devices" (No. 64, 2014) is simultaneously repealed.

                                                                                   02 Strengthen Quality Assurance Requirements

1. Fulfill the primary responsibility for medical device quality and safety, establish quality objectives in accordance with medical device quality management
requirements, and systematically implement all requirements regarding the safety, effectiveness, and quality controllability of medical devices throughout the
entire operation of the quality management system to ensure that quality objectives are fully understood and effectively achieved.

2. Allocate sufficient personnel, premises, facilities, and equipment that meet the required standards to achieve quality objectives. All levels of personnel within
the enterprise shall jointly participate in activities aimed at achieving quality objectives and bear corresponding responsibilities.

3. Establish a quality assurance system and maintain complete quality management system documentation to ensure the effective operation of the qualitymanagement system.

4. Establish a change control procedure, determine the type of change management according to the risk level of the impact of changes on the safety, effectiveness,
and quality controllability of medical devices and relevant regulatory requirements, conduct evaluations of changes, and obtain appropriate approvals prior to implementation.
Where necessary, changes shall be verified and validated to ensure that they do not adversely affect the safety, effectiveness, and quality controllability of the product.

5. Establish a quality risk management system, assess quality risks throughout the entire product realization process based on laws, regulations, rules, standards, scientific knowledge,
and experience, and validate and implement quality risk control measures to ensure effective control of product quality risks.

6. Collect quality risk information throughout the product lifecycle and regularly conduct reviews of quality risk management to ensure the continued effectiveness of
quality risk management measures.

                                                         03 Clarification of Qualification Requirements for Organizations and Personnel

1. Establish an organizational structure commensurate with medical device manufacturing, clearly define the responsibilities and authorities of each department,
and clarify quality management functions. The heads of production and quality management departments must not hold dual positions.

2. Equip key personnel commensurate with the products being manufactured. Key personnel shall at least include the legal representative, principal responsible person,
management representative, head of production management department, head of quality management department, and product release reviewer. The principal responsible
person, management representative, head of production management department, head of quality management department, and product release reviewer shall be full-timeemployees of the enterprise.

3. Appoint a management representative from among senior managers. For manufacturers of Class II and Class III medical devices, the management representative shall
have a bachelor's degree or above in a medical device-related field, or hold a mid-level or higher technical title. For manufacturers of Class I medical devices, the management
representative shall have an associate degree or above in a medical device-related field. The management representative should generally have at least three years of experience
in medical device quality management, production, or technical management, be familiar with product manufacturing and quality management, and possess strong capability to
fulfill responsibilities. The management representative shall assume primary responsibility for medical device product safety and quality, establish quality objectives meeting medical
device quality management requirements, systematically implement all requirements for safety, effectiveness, and quality control of medical devices throughout the entire operation of
the quality management system, and ensure that quality objectives are fully understood and effectively achieved.

4. The head of the quality management department in a Class II or Class III medical device manufacturer shall have a bachelor's degree or above in a medical device-related field, or hold a
mid-level or higher technical title; for Class I medical device manufacturers, the head of the quality management department shall have an associate degree or above in a medical device-related field.
The head of the quality management department shall have at least three years of experience in medical device production or quality management. Sufficient personnel, premises, facilities,
and equipment meeting requirements shall be provided to achieve quality objectives. All personnel at various levels within the enterprise shall jointly participate in activities aimed at achieving
quality objectives and bear corresponding responsibilities.

5. The head of the production management department shall have an associate degree or above in a medical device-related field and possess at least three years of experience
in medical deviceproduction or quality management.