Recently, in order to further standardize the clinical evaluation of medical devices, and expand the scope of medical device catalogues exempted from clinical trials, according to the "Administrative Measures for the Registration of Medical Devices" and the "Regulations on the Administration of Registration of In Vitro Diagnostic Reagents", the Device Registration Division of the Food and Drug Administration has organized Drafted the second category of medical devices exempted from clinical trials (second batch) and the third category of medical devices exempted from clinical trials (second batch) (draft for comments, see attachment) The unit is now invited to organize research and feedback before June 20, 2016. Other units or individuals may submit feedback via the above email or letter, and the deadline for comments is the same as above. Annex 1 "Catalogue of the Second Class of Medical Devices Exempted from Clinical Trials (Second Batch)" (Draft for Comment) Hongxing Factory Cotton Ann Cap,Cotton Safety Cap,Cotton Safety Helmet,Safety Cotton Cap Dongying Hong Xing Labor Protection Products Co.,Ltd. , https://www.hongxinglabor.com
Dongying Hongxing is located at Dongying City, Shandong Province China since 1995.
We have 30 categories of products, including Covid-19 products, frock, protection shoes, safety belt, Special gloves.
Our main customer in China is Sinopec, Petro China, Energy company, steel company and Tabacco Company in other countires. Our factory have 500workers and 22 technical employees and invest thirty eight million dollars .
FAQ
1. What are your main products ?- Safety shoes
- Protective helmet
- Work clothes
- Safety cloves
- Protective equipment and masks
2. Can you offer OEM ?
Our company accep OEM service , if you need, please inform us of your specific requirements
3. What's your mode of transportation ?
By sea, By air, By train, By truck, as your request. We also do a good job to deliver goods to your destination.
4. What's your payment terms ?
T/T, L/C, Paypal..... If you need to pay via other ways, please negotiate with us.
5. Can you offer sample ?
Yes, we can offer samples to help you check type and quality.
6. Are you manufacturer or trader ?
We have own factory in Donying city, Shandong province, welcom to visit our factory !
List of medical devices that are exempt from clinical trials (second batch)