China Expands Medical Device Marketing Authorization Holder Pilot to 21 Provinces, Accelerating Innovation and Resource Allocation

VCBeat (WeChat ID: vcbeat) has learned that, in order to thoroughly implement the “Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices” (General Office Document [2017] No. 42) issued by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council, accelerate innovative development in the medical device industry, and further accumulate experience for the comprehensive implementation of the Medical Device Registrant System, the National Medical Products Administration (hereinafter referred to as the NMPA) has decided to further expand the pilot program for the Medical Device Registrant System, building upon the pilots previously conducted in the Shanghai, Guangdong, and Tianjin Free Trade Zones. The specific details of the opinions are as follows.

I. Pilot Scope

Beijing, Tianjin, Hebei, Liaoning, Heilongjiang, Shanghai, Jiangsu, Zhejiang, Anhui, Fujian, Shandong, Henan, Hubei, Hunan, Guangdong, Guangxi, Hainan, Chongqing, Sichuan, Yunnan, and Shaanxi Provinces (Autonomous Regions, Municipalities).

The Medical Device Registrant System was previously piloted in Shanghai, Beijing, and other regions, with several products gaining approval through this channel. Notable examples that obtained registration certificates under the system include Yuexin Medical Technology Co., Ltd.’s single-channel ECG recorder, Medtronic’s surgical power system, and the “customized additively manufactured knee orthosis” developed by a team led by Dai Kerong, an academician of the Chinese Academy of Engineering.

II. Pilot Content and Objectives

(1) Explore the establishment of a management system for contracted manufacturing of medical devices, optimize resource allocation, and implement principal responsibility. An applicant for medical device registration (hereinafter referred to as the “applicant”) who applies for and obtains a Medical Device Registration Certificate shall become the medical device registrant (hereinafter referred to as the “registrant”). The applicant may entrust enterprises with corresponding production capabilities to manufacture samples, and the registrant may entrust one or more enterprises with production capabilities to manufacture products that have already obtained certification. Group companies are encouraged to further integrate and optimize resource allocation and fulfill the principal responsibility of medical device registrants through pilot programs of the registrant system.

(2) Explore the establishment of a comprehensive quality management system for registrants of medical devices, clarify the legal relationships among entities such as medical device registrants and entrusted parties, and build a lifecycle quality management system and framework for registrants based on clear responsibilities and controllable risks.

(3) Explore innovative regulatory approaches for medical devices, effectively implement the requirement that “regulatory efforts must keep pace,” improve the system of in-process and ex-post oversight, clarify cross-regional regulatory responsibilities, establish a robust mechanism for cross-regional collaborative supervision, strengthen regulatory synergy, and enhance regulatory effectiveness.

(4) Explore the release of dividends from the Medical Device Registrant System, encourage innovation in medical devices, and promote high-quality development of the medical device industry.

(5) Accumulate experience from the pilot program of the Medical Device Registrant System, providing important support for the comprehensive implementation of the Medical Device Registrant Management System.

Products listed in the Catalogue of Medical Devices Prohibited from Contract Manufacturing, issued by the former China Food and Drug Administration, are temporarily excluded from the pilot program.

III. Conditions and Obligations of the Registrant

(I) Registrant Requirements

1. Enterprises and research institutions whose domicile or production address is located within the provinces, autonomous regions, and municipalities directly under the Central Government participating in the pilot program.

2. Possess dedicated technical and managerial personnel for regulatory affairs, quality management, post-market surveillance, and related functions, with knowledge and experience in medical device regulatory regulations and standards.

3. Establish a quality management system appropriate for the product and maintain its effective operation, with personnel responsible for independently evaluating, auditing, and overseeing the quality management system.

4. Possess the capability to assume responsibility for the quality and safety of medical devices.

(II) Obligations and Liabilities of the Registrant

1. Bear corresponding legal responsibilities in accordance with the law for activities including medical device design and development, clinical trials, manufacturing, sales and distribution, after-sales service, product recall, and adverse event reporting.

2. Enter into an entrustment contract and a quality agreement with the contracted manufacturer to clarify responsibilities regarding technical requirements, quality assurance, allocation of liabilities, and release requirements in entrusted production, and to specify the requirements for production release and the methods for product market release.

3. Strengthen supervision and management of contract manufacturers, assess their quality management capabilities, and conduct regular evaluations and audits of their quality management systems.

4. Strengthen adverse event monitoring and establish corresponding traceability management systems for medical devices based on risk levels, ensuring that medical device products meet the requirements for full-process traceability.

5. Medical device registrants may sell their products directly or entrust qualified medical device distributors to do so. Registrants engaging in direct sales must possess the prescribed operational capabilities and conditions for medical device distribution; for entrusted sales, a written agreement shall be executed to clearly define the rights and obligations of all parties involved.

6. Utilize information technology to achieve full-process traceability and monitoring of research and development, production, sales, and adverse event surveillance.

7. Ensure that the submitted research materials and clinical trial data are authentic, reliable, systematic, complete, and traceable.

IV. Conditions and Obligations of the Entrusted Manufacturing Enterprise

(I) Conditions for Entrusted Manufacturing Enterprises
1. Enterprises whose domicile or production address is located within the provinces, autonomous regions, and municipalities directly under the Central Government participating in the pilot program.
2. Possess a quality management system and production capacity commensurate with the entrusted production of medical devices.

(II) Obligations and Liabilities of the Entrusted Manufacturing Enterprise
1. Assume the obligations stipulated in the Regulations on the Supervision and Administration of Medical Devices, other relevant laws and regulations, as well as the entrusted contract and quality agreement, and bear corresponding legal liabilities.
2. Organize production in accordance with the requirements stipulated by medical device regulations, as well as those agreed upon in the entrustment contract and quality agreement, and bear corresponding quality responsibilities to the registrant.
3. In the event of a major quality incident involving a medical device after it has been marketed, a report shall be promptly submitted to the provincial-level drug regulatory authority where the entity is located.
4. Upon termination of entrusted production, the entrusted manufacturer shall apply to the provincial drug regulatory authority in its locality for the removal of the information on the entrusted products from the list of manufactured products attached to the Medical Device Production License.
5. The commissioned manufacturing enterprise shall not further subcontract the production.

V. Application Procedures

(1) Registration Application. Where a registration applicant submits an application for medical device registration, it shall submit the registration application materials to the corresponding drug regulatory department. Upon review and confirmation of compliance with requirements, a Medical Device Registration Certificate shall be issued. If the manufacturing address listed in the Medical Device Registration Certificate is that of the entrusted manufacturer, the name of the entrusted enterprise shall be indicated in the remarks section.

(II) Processing of Production Licenses. If the entrusted manufacturer does not possess the corresponding production qualifications, it may apply for a production license or for an amendment to the production license by submitting the registrant’s medical device registration certificate. For cross-regional pilot programs, such applications shall be submitted to the provincial drug regulatory authority where the entrusted manufacturer is located.

(3) Procedures for Changing Registered Production Address. Where a registrant intends to change the production address on the registration certificate through contracted manufacturing, the provincial drug regulatory authority where the contracted manufacturer is located shall, in conjunction with the provincial drug regulatory authority where the registrant is located, conduct an on-site inspection, and the provincial drug regulatory authority where the contracted manufacturer is located shall amend the Medical Device Manufacturing License. The registrant shall apply to the relevant drug regulatory authority for registration item changes by submitting the amended Medical Device Manufacturing License of the contracted manufacturer and the entrustment agreement.

(4) Filing by the Entrusted Party. The entrusted manufacturing enterprise shall file with the provincial-level drug regulatory authority in its locality, and shall submit documents such as the entrustment contract and quality agreement at the time of filing.

VI. Work Requirements

(I) Strengthen organizational coordination. The National Medical Products Administration (NMPA) is responsible for organizing the pilot implementation of the Marketing Authorization Holder (MAH) system for medical devices nationwide. The drug regulatory departments of each pilot province shall establish a pilot working group led by a deputy director in charge, study and formulate implementation plans and relevant management systems for the pilot work, improve operational mechanisms, allocate sufficient resources, strengthen the development of professional and specialized inspector teams, and solidly advance the pilot initiatives. Based on local conditions regarding the medical device industry and regulatory oversight, and following thorough research and deliberation, the drug regulatory departments of each pilot province shall promptly develop their respective pilot work plans and submit them to the NMPA in a timely manner.

(II) Strengthening Supervision and Administration. Drug regulatory authorities at all levels shall strengthen supervision and administration of registrants’ fulfillment of their obligations, including ensuring the quality of medical devices, managing market sales and services, monitoring and evaluating adverse events associated with medical devices, and conducting medical device recalls. For cross-regional pilot programs, provincial-level drug regulatory authorities shall, on the basis of coordination and consensus, define the division of responsibilities among parties involved in cross-regional supervision, designate the primary entities responsible for routine supervision, and ensure seamless, comprehensive oversight throughout the entire lifecycle and supply chain of medical devices. Mechanisms for collaborative management, information sharing, and mutual recognition of results shall be established. Drug regulatory authorities may conduct extended inspections of other relevant entities that provide products or services for activities related to the research and development, manufacturing, distribution, and use of medical devices.

(3) Encouraging Social Participation. Provincial drug regulatory departments in pilot regions shall fully leverage the role of industry associations to solicit opinions and suggestions from enterprises; organize legal experts to study and draft model templates for entrustment agreements; and encourage social forces to actively participate, in appropriate forms, in building enterprises’ capacity to assure quality responsibility.

(4) Promoting information sharing. The provincial drug regulatory departments participating in the pilot programs shall, in accordance with relevant regulations, proactively disclose and promptly submit to the National Medical Products Administration (NMPA) updates on the progress and latest developments of the pilot initiatives.

(5) Timely summarize experience. The provincial drug regulatory departments involved in the pilot programs shall monitor and track the implementation throughout the process, conduct timely summaries, analyze the achievements made and issues encountered, formulate recommendations for resolution, and promptly report to the National Medical Products Administration.