A Draft of Guidelines for Product Classification Definition Released

Recently, the Standards Management Center issued a notice on soliciting opinions on the Guiding Principles for the Classification and Definition of Immunohistochemical In Vitro Diagnostic Reagents (Draft for Comments)，The contents are as follows:

All relevant units and individuals:

According to the requirements of NMPA, the Medical Device Standards Management Center of the NMPA took the lead in organizing the clinical laboratory professional group of the Technical Committee for Classification of Medical Devices to study and prepare the Guiding Principles for the Classification and Definition of Immunohistochemical In Vitro Diagnostic Reagents (hereinafter referred to as the Guiding Principles), which formed the draft for comments (Appendix 1) and the preparation instructions (Appendix 2). Now, we are open for comments.

If you have any comments or suggestions, please fill in the guiding principles consultation form (Annex 3) and send it to tws-xbs@nifdc.org.cn before November 2, 2022. Please indicate the name of the feedback organization or personal name on the subject of the email.

Enclosure:

1. Guidelines for Classification and Definition of Immunohistochemical In Vitro Diagnostic Reagents (Draft for Comments)

2. Preparation description of Guiding Principles for Classification and Definition of Immunohistochemical In Vitro Diagnostic Reagents

3. Consultation Form for Guiding Principles for Classification and Definition of Immunohistochemical In Vitro Diagnostic Reagents

   For more details of the Englishi copy of  guidelines ,please e-mail  info@bradyknowsmedical.com.