China Domestic Production of Imported Medical Devices – draft for comments

China domestic production of imported medical devices policy has been drafted and released by the National Medical Products Administration (NMPA) on November 4,2024. This initiative is a significant step in the government’s efforts to deepen regulatory reform, promote industry openness, and drive the high-quality development of the medical device sector in China.

The draft is now open for public comments, with submissions due by December 2, 2024. This draft builds upon the 2020 Announcement (No. 104) and aims to clarify the regulatory requirements for foreign-invested enterprises seeking to manufacture imported medical devices domestically.

The policy aligns with broader government goals to enhance the country’s healthcare infrastructure, reduce dependency on imports, and meet growing public demand for medical devices.

Key Highlights of the Draft Policy

1) Scope of Application

The draft specifies that it applies to foreign-invested enterprises established by registrants of imported medical devices or those with the same actual controller. These enterprises are permitted to manufacture Class II or III medical devices that have already been granted registration certificates for import.

The policy also emphasizes compliance with the Company Law of the People’s Republic of China to ensure legal alignment.

2) Simplified Registration Requirements

The draft introduces streamlined processes for registration, allowing applicants to use data from previously approved registrations of imported devices. Key requirements include:

Updated technical standards and inspection reports reflecting compliance with applicable mandatory standards.
Supporting documentation to verify the actual controller and their relationship with the registrant.
Notarized authorization from the registrant to allow domestic production using previously submitted registration data.

By simplifying the use of existing data, the SDA aims to encourage foreign-invested enterprises to transition to domestic production without compromising product quality or regulatory oversight.

3) Focus on Quality Management System (QMS) Verification

Applicants are required to demonstrate that domestic production processes align with China’s Good Manufacturing Practice (GMP) for Medical Devices. Additionally, they must provide:

A self-inspection report comparing domestic and international quality management systems.
Risk analyses for any discrepancies, ensuring safety, effectiveness, and quality remain uncompromised.

Authorities will conduct comprehensive QMS verifications, with a particular focus on design, development, and equivalence between domestic and imported systems.

4) Support for Innovation and Regulatory Consistency

The draft policy prioritizes the registration of innovative medical devices manufactured domestically, underscoring China’s commitment to fostering innovation. Moreover, it provides clear guidance on subsequent changes, renewals, and modifications to registrations in compliance with existing regulatory frameworks, such as the Medical Device Registration and Filing Management Measures.

Implications for Stakeholders

This draft policy reflects China’s growing emphasis on regulatory modernization and alignment with global best practices. For medical device manufacturers, this initiative provides an opportunity to:

Leverage existing registrations to expand domestic production.
Align with streamlined registration and quality management requirements.
Contribute to the high-quality development of the Chinese medical device sector.

Stakeholders are encouraged to review the draft policy and submit their feedback to ylqxzc@nmpa.gov.cn with the subject line “Feedback on Import to Production” by the deadline. The NMPA’s draft announcement represents a pivotal move towards enhancing the domestic manufacturing landscape for imported medical devices in China.

By simplifying registration processes, emphasizing quality management, and prioritizing innovation, the draft sets a strong foundation for regulatory reform and industry growth.