NMPA Issues Guidance on Classification of Next-Generation Sequencing IVD Reagents
On June 16, 2025, China’s National Medical Products Administration (NMPA) released the “Guidance for the Classification of In Vitro Diagnostic (IVD) Reagents Related to Next-Generation Sequencing” (hereafter referred to as the “Guidance”), aiming to strengthen the supervision and management of NGS-related IVD products and support the high-quality development of the industry.
Key Points of the Announcement:
1. Immediate Effect:
The Guidance takes effect immediately. Applicants must determine the regulatory attributes and classification of NGS-related IVDs in accordance with the Guidance.
2. Module Registration Requirements:
General sequencing reagents and library construction reagents are encouraged to be registered as a single unit for Class III IVDs. If separate registration is necessary, applicants must clearly define the distinction between the two based on functionality, technical characteristics, and composition.
For library construction reagents, the compatible sequencing reagents must be specified.
For sequencing reagents, the compatible instrument brands and models (which must already hold a medical device registration certificate) must be specified when filing records.
3. Management of Previously Filed IVDs:
Enterprises that have filed NGS-related IVDs as Class I prior to the issuance of this Guidance must review and update their filing information. If filings need to be changed or cancelled, this must be done in accordance with existing regulations and announcements. For products that, according to the new Guidance, should not be managed as Class I IVDs, enterprises must apply for registration with the appropriate drug supervision departments as per the relevant 2024 guidance document. From January 1, 2027, unregistered products cannot be manufactured, imported, or sold.
The NMPA will continue to support the standardized development of next-generation sequencing IVDs to ensure product quality and patient safety.