In order to strengthen the supervision and guidance on the registration of medical devices and further improve the quality of registration and examination, the administration of food and drug administration has formulated eight guiding principles for the examination of registration technology, such as heat and moisture exchanger (see Annex).

It is hereby notified.

enclosure:

1. Guidelines for technical review of heat and moisture exchanger registration

2. Guiding principles for technical review of low frequency electrotherapy instrument registration

3. Guiding principles for technical review of electric pneumatic hemostat registration

4. Guiding principles for technical review of pulmonary ventilation function test product registration

5. Guiding principles for technical review of medical carbon dioxide incubator registration

6. Guiding principles for technical review of shock wave therapeutic apparatus registration

7. Guidelines for technical review of hot compress (bag) product registration

8. Guidelines for technical review of audiometer registration

**China food and Drug Administration June 9, 2020

Annex 1 guiding principles for technical review of heat and moisture exchanger registration. Doc Annex 2 guiding principles for technical review of low frequency electrotherapy apparatus. Docx Annex 3 guiding principles for technical review of electric pneumatic hemostatic apparatus registration technology +. Docx Annex 4 guiding principles for technical review of pulmonary ventilation function test products. Doc Annex 5 guiding principles for technical review of medical carbon dioxide incubator registration. Doc Annex 6 Registration Technology of shock wave therapeutic apparatus Docx Annex 7 guidelines for technical review of hot patch (bag) product registration. Docx Annex 8 guidelines for audiometer registration technical review.docx

Source: State Food and Drug Administration