Editor's note:

The Implementation Plan for the Pilot Program on In Vitro Diagnostic Reagents Developed and Used by Medical Institutions in Shanghai has recently been officially released. Following the issuance of LDT pilot documents by proactive cities such as Guangzhou, Shanghai and Hangzhou, the policy has finally moved into the implementation stage. While the pilot institutions are leading hospitals, third parties are also being encouraged to participate and to provide outsourced services. The involvement of universities, enterprises and third-party diagnostic institutions is expected to accelerate R&D efficiency and the translation of research results into practice.

The pilot medical institutions include: Fudan University Shanghai Cancer Center; Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine; Zhongshan Hospital, Fudan University; and Ruijin Hospital, Shanghai Jiao Tong University School of Medicine.

The document proposes to carry out pilot trials of in vitro diagnostic reagents developed by medical institutions themselves, giving priority to meeting the clinical needs of the pilot institutions in areas such as the diagnosis and treatment of rare and difficult diseases and birth defects. Using the pilot work as an entry point, it aims to accumulate experience and refine management requirements, laying the foundation for establishing a nationwide system.

The following key points of the Implementation Plan deserve attention:

Key Point 1: Risk Must Remain Controllable Throughout the Entire Process

Medical institutions must assume their primary responsibilities, and explore the formation of a replicable, scalable quality management system and internal review system for self-developed reagents. Risk monitoring and assessment should be carried out across the entire process of selecting, developing, preparing and using self-developed reagent products, regulatory oversight at each stage should be better coordinated, and risk prevention and control measures should be implemented throughout.

Key Point 2: Registration Applications Are Encouraged

Registration applications are encouraged; the document explores pathways for applying clinical data generated during the use of self-developed reagents to in vitro diagnostic (IVD) registration filings, establishing a model for converting self-developed reagents with clear clinical significance and clear patient benefit into registered IVD products.

Key Point 3: Product Categories May Fill Domestic Gaps

Pilot products must be IVD reagents for which no comparable product has yet been marketed in China, with mature technology and clear clinical significance, and must either be recommended by relevant domestic or international clinical practice guidelines or shown by clinical studies to be ready for clinical use.

Key Point 4: Collaborative Development with Upstream and Downstream Enterprises

Regarding the requirements for development and preparation by medical institutions, an institution may prepare reagents itself or commission an enterprise based in Shanghai that holds a medical device manufacturing license covering Class II or Class III IVD reagents. Where preparation is commissioned, the pilot medical institution shall sign an entrustment contract and a quality agreement with the commissioned manufacturer, specifying the rights and obligations of both parties with respect to the quality and safety of the self-developed reagents. The commissioned manufacturer shall organize preparation in accordance with laws and regulations, good manufacturing practice for medical devices, mandatory standards, product technical requirements, the entrustment contract and the quality agreement; it shall be responsible for its preparation activities and subject to the supervision of the commissioning party.