How long does it take to get CE, FDA for medical device surgical consumables

CE depends on the classification of the product. CE medical devices are divided into 3 categories. Class I, Class II, Class III. Among them, one class is divided into ordinary and sterilization, measurement class. A class of ordinary kind, some as long as a week. Some take a month. Class III, such as enteric line, collagen, cardiac catheters, artificial heart, etc. , these cycles are often 1.5 years -2 years, or even longer.

The FDA is also the same to see exactly what products, and then look at the U.S. medical device classification belongs to. The cycle is short, 7 days, 30 days. Some things like X-ray machines, ultrasound instruments, monitors, eye crystals, etc., tend to be a year.

Just looking at the name of your product, it is estimated to be 1-3 months to put. Because you didn't send the exact name of the product and the manual. There is no way to determine in detail.

CE's certificate is issued by a third-party certification body. FDA is issued by the US National Food and Drug Administration.

I handle CE and FDA registration here. The screen name is my cell phone number. You call me on my cell phone.