Regulatory News | Guidelines for the Classification and Definition of Class I Products Released!

On the 10th, in order to further strengthen the supervision and management of in vitro diagnostic reagent products related to next-generation gene sequencing, the National Medical Products Administration organized and formulated the “Guidance Principles for the Classification and Definition of In Vitro Diagnostic Reagents Related to Next-generation Gene Sequencing” (hereinafter referred to as the Guidance Principles), which is hereby released.

Ⅰ. These guiding principles shall come into force as of the date of promulgation. Applicants shall determine the management attributes and classification of in vitro diagnostic reagents related to next-generation gene sequencing in accordance with the guiding principles.

II. Sequencing reaction general reagents and library construction reagents must be used in combination to complete the sequencing function. It is encouraged to form the same registration unit for both and jointly apply for the registration of Class III in vitro diagnostic reagents.

If the general reagents for sequencing reactions and the reagents for library construction indeed need to be declared as different units separately, the applicant should clarify the division between the two from the perspectives of realized functions, technical characteristics, and structural composition. When registering the reagents for library construction, the general reagents for sequencing reactions that they are compatible with should be specified. When filing the general reagents for sequencing reactions, the brand and model of the compatible instruments (the instruments need to be compatible with the second-generation gene sequencing instruments that have obtained the medical device registration certificate) should be specified.

III. For in vitro diagnostic reagents related to next-generation gene sequencing that have been filed as Class I in vitro diagnostic reagents before the release of these Guiding Principles, the filer shall conduct a self-examination of the filing information and filing materials against the Guiding Principles. For matters involving filing changes or cancellations, they shall be handled in accordance with the Measures for the Registration and Filing of In Vitro Diagnostic Reagents and the Announcement of the National Medical Products Administration on Matters Related to the Filing of Class I Medical Devices. For products that should not be managed as Class I in vitro diagnostic reagents according to the Guiding Principles, in accordance with the requirements of the Notice of the National Medical Products Administration on Matters Concerning the Implementation of the Classification Catalogue of In Vitro Diagnostic Reagents (No. 17, 2024), an application for registration shall be submitted to the corresponding drug regulatory department. From January 1, 2027, products without a registration certificate obtained in accordance with the law shall not be produced, imported, or sold.

Scope of application

The classification and definition of in vitro diagnostic reagents related to next-generation gene sequencing can refer to this guiding principle. The next-generation gene sequencing technology described in this guiding principle, also known as high-throughput sequencing technology, refers to a type of gene sequencing technology with highly parallelized sequencing units and relatively short single read lengths.

Management category definition

In vitro diagnostic reagents related to next-generation gene sequencing can usually be divided into units such as nucleic acid extraction and purification reagents, library construction reagents, and general sequencing reaction reagents. Nucleic acid samples prepared by nucleic acid extraction and purification reagents are used to construct sequencing libraries through library construction reagents, and gene sequencing is completed on a gene sequencer using general sequencing reaction reagents.