Regulatory Update on the Commercial Diagnostic Test Evaluation Process at the Institute of Epidemiological Diagnosis and Reference (INDRE)

The communication issued by INDRE on April 5, 2024, informs about the opening process for requesting the evaluation of commercial diagnostic tests.

Update

The process for evaluating commercial diagnostic tests is open for:

  1. Human Brucellosis: Diagnostic tests (immunoassays, chemiluminescence, nucleic acid detection, automated bacterial detection systems, or mass spectrometry).

  2. Human Toxoplasmosis: Serological diagnostic tests (immunoassays).

  3. Viral infections by HIV, hepatitis B, and C: Viral load quantification and lymphocyte determination.

  4. Chagas: Serological diagnosis integrating diagnostic standards - Rapid tests will not be assessed.

NOTE:

  • The sample reception will depend on InDRE's capacity.
    This communication is specific to April 8 to 12 without mentioning its scope for the rest of the year.

Regulatory framework

By the provisions outlined in the guide for obtaining the sanitary registration of Class III medical devices, specifically in section 2.6 regarding "Laboratory Tests," and in compliance with the provisions of Article 179, Section VII of the Health Supplies Regulation, as well as in Normative Appendix III of the Guidelines for obtaining the sanitary registration of a medical device from the Medical Device Supplement of the FEUM, and following Article 16 of the Health Supplies Regulation.

Effects from the RA update

The tests must adhere to the techniques and criteria specified in the communications to ensure uniformity in the evaluation. Manufacturers and suppliers must be informed about the application period, the closure of the process, and future reopenings of InDRE communications, thus ensuring timely submission.

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