Drugdu.com expert's response:

As high-risk medical devices, Class III in vitro diagnostic reagents have registration requirements covering multiple aspects, as detailed below:

I. Management Category and Registration Pathway

Management Category: Class III in vitro diagnostic reagents are subject to registration management and are directly approved by the National Medical Products Administration (NMPA).

Registration Pathway:

For newly developed products not yet listed in the classification catalog of in vitro diagnostic reagents, applicants may directly apply for the registration of Class III in vitro diagnostic reagents or determine the product category in accordance with classification rules, apply to the NMPA for category confirmation, and then apply for product registration or handle product filing.

For direct applications for the registration of Class III in vitro diagnostic reagents, the NMPA will determine the category based on the risk level.

II. Product Technical Requirements and Registration Inspection

Product Technical Requirements:

Applicants or filers should formulate product technical requirements based on the results of product development and clinical evaluation, under the premise of stable raw material quality and production process.

Product technical requirements mainly include performance indicators and testing methods for finished in vitro diagnostic reagents, where performance indicators refer to objective functional and safety indicators of the finished product, as well as other indicators related to quality control.

For Class III in vitro diagnostic reagents, the product technical requirements should specify the main raw materials, production process, and semi-finished product requirements in the form of appendices.

Registration Inspection:

Applications for the registration of Class II and Class III in vitro diagnostic reagents should undergo registration inspection. For Class III products, registration inspection should be conducted on samples from three consecutive production batches.

Medical device inspection institutions should inspect relevant products in accordance with product technical requirements and issue registration inspection reports.

The production of samples for registration inspection should comply with the relevant requirements of the medical device quality management system. Only after passing the registration inspection can clinical trials be conducted or registration applications be submitted.

III. Clinical Evaluation and Clinical Trials

Clinical Evaluation:

Clinical evaluation of in vitro diagnostic reagents refers to the process by which applicants or filers confirm whether a product meets usage requirements or intended uses through information such as clinical literature, clinical experience data, and clinical trials.

Clinical evaluation data refers to the documents generated by applicants or filers during the clinical evaluation process.

Clinical Trials:

Applications for the registration of Class II and Class III in vitro diagnostic reagents should undergo clinical trials, except for products that meet specific conditions (e.g., clear reaction principles, established designs, and mature production processes) that may be exempt from clinical trials.

For Class III products, applicants should select at least three (inclusive) qualified clinical trial institutions and conduct clinical trials in accordance with relevant regulations. The production of clinical trial samples should comply with the relevant requirements of the medical device quality management system.

The number of clinical trial cases should be determined based on the purpose of the clinical trial, statistical requirements, and with reference to relevant technical guidance principles.

IV. Quality Management System and Production Capacity

Quality Management System:

Enterprises should establish a quality system that complies with the ISO 13485 standard, covering the entire process of research and development, production, storage, and transportation.

They need to implement raw material control, process monitoring, finished product inspection, and stability studies to ensure product traceability.

Real-time stability studies should cover the product's shelf life, and transportation stability should be verified by simulating actual conditions.

Production Capacity: Enterprises should possess the production capacity for the proposed registered products and establish a medical device production quality management system in accordance with the requirements of the "Medical Device Production Quality Management Practices."

V. Registration Application Documents and Requirements

Application Documents: When applying for the registration of in vitro diagnostic reagents, applicants should submit application documents to the drug regulatory authority in accordance with relevant requirements, including an application form, proof documents, summary documents, research data on main raw materials, research data on main production processes and reaction systems, analytical performance evaluation data, data on the determination of positive judgment values or reference intervals, stability study data, production and self-inspection records, clinical evaluation data, product risk analysis data, product technical requirements, product registration inspection reports, product instructions, label drafts, and compliance declarations, etc.

Document Requirements:

Application documents should be in Chinese. If translated from foreign language materials, the original text should also be provided.

When citing unpublished literature, proof of permission for use from the owner of the materials should be provided.

Applicants and filers are responsible for the authenticity of the documents.