14 Medical Device Product Registration Review Guidelines Released

In order to further standardize the management of medical devices such as blood melting equipment, the Center for Device Evaluation of the State Food and Drug Administration organized and issued 14 guidelines for the registration and review of medical device products including the “Guidelines for the Registration and Review of Blood Melting Devices”:

1. Guidelines for registration review of blood melting equipment

2. Guiding principles for the registration review of medical respiratory humidifiers

3. Intestinal hydrotherapy machine registration review guidelines

4. Guidelines for Registration Review of Medical Molecular Sieve Oxygen Concentrators

5. Guiding Principles for Registry Review of Bladder Ultrasound Scanner

6. Guidelines for registration review of single-use peritoneal dialysis catheters

7. Guiding Principles for Registry Review of Respiratory Filters

8. Oropharyngeal/nasopharyngeal airway registration review guidelines

9. Guiding principles for liquid dressing product registration review

10. Guidelines for registration review of gel dressing products

11. Guidelines for registration review of β-hydroxybutyric acid detection reagents

12. Guiding principles for the registration review of methotrexate detection reagents

13. Guiding principles for the registration review of anti-cyclic citrullinated peptide antibody detection reagents

14. Guiding principles for the registration review of reagents for the identification of Gram-positive bacteria