A number of recent guidelines for comment!

Recently, CMDE has released 15 draft guidelines:

1. Guidelines for the Evaluation of the Safety and Efficacy of Medical Devices Applying Nanomaterials Part III: Biocompatibility/Toxicological Evaluation (Draft for Comments)

2. Guidelines for the Review of the Registration of Aspergillus nucleic acid Test Reagents (Draft for Comments)

3. Guidelines for Review of the Registration of Human Immunodeficiency Virus Test Reagents for Clinical Trials (Revised Draft for Comment in 2022)

4. Guidelines for Registration and Review of Quantitative Shear Wave Ultrasonic Liver Measuring Apparatus (Draft for Consultation)

5. Guidelines for Registration and Application Data of Self testing Blood Glucose Monitoring System (2022 Revision for Comments)

6. Guidelines for the Review of Registration of detection reagents for Gene Mutations associated with Personalized Tumor Therapy (Draft for Comment on the 2022 Revision)

7. Guidelines for the Review of Registration of Quantitative Hepatitis B Virus deoxyribonucleic acid Test Reagents (Revised Draft for Comment in 2022)

8. Guidelines for the Review of the Registration of influenza virus Antigen Test Reagents (Revised Draft for Comment in 2022)

9. Guidelines for the Review of the Registration of nucleic acid Test Reagents for Influenza Virus (2022 Revised Draft)

10. Guidelines for Technical Review of affinity Test reagents for antibodies to Toxoplasma, rubella virus, Cytomegalovirus, herpes simplex virus and G-type immunoglobulin Antibodies (Revised 2022 Draft)

11. Guidelines for the Review of Registration of Pathogen Specific M-type immunoglobulin Qualitative Test Reagents (Revised 2022 Draft for Comment)

12. Guidelines for Registration and Examination of Bladder Ultrasound Scanners (Draft for Comments)

13. Guiding Principles for Registration and Examination of EEG Products (Draft for Comments)

14. Guidelines for the Registration and Review of Invasive Blood Pressure Monitoring Products (Draft for Comments)

15. Guidelines for the Registration and Review of Invasive Pressure Sensor Products (Draft for Comments)

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com