China: CMDE Publishes 12 Registration Review Guidance & Research Review Registration Guidelines for Main Raw Ingredients of IVD Reagents

On the 2nd January 2024, the Device Review Centre of the State Food and Drug Administration released the notice on the revision for 12 registration review guidelines and research registration review guidelines for the main raw ingredients of in vitro diagnostic reagents. The main objective of the revision is to provide structural guidance for formulating the in vitro diagnostic reagents and technical reference for regulatory authorities during the review.

The revised guidelines consist of documents and guidance that can assist regulatory affairs professionals in preparing the registration, filing, and management of the in vitro diagnostic reagents including the approval certificates. There are many pivot keys focussed in the guidelines:

• Main information: reagent components description, quantities, names, materials used, quantities, and many more

• Product name: product naming principles

• Packing specifications: number of samples, number of samples, samples for testing

• Intended use: type of tests (qualitative, quantitative), types of samples

• Test method: details instructions for reagent preparation, sample processing, calibration, and result interpretation

• Warning & Precautions: mention the limitation, after effects, or warnings for the in vitro use and substances consisting of human or animal origin in the products

Manufacturers are allowed to alter the guidance according to the characteristics and intended use of the products due to the diverse nature of in vitro reagents with varying clinical use and methodologies. Hence, manufacturers can deliver accurate information about the products to patients or users. The guidelines will be reviewed from time to time to ensure the data accuracy and adaptability to the current trends.

Source: Centre of Medical Device Evaluation (CMDE)

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