During the epidemic, since many people applied for FDA, FDA opened a fast track. As long as you submit information and submit an application, you can usually get FDA. Before the epidemic, FDA would come to China for surprise inspections, but now it is no longer the case, so this is why even many trading companies have obtained FDA, and some professional customers dare not rely solely on FDA.
Medical CE is different. It is very strict and difficult when applying, and the cycle is very long. The machine must be sent to a compliant testing agency for strict testing before a report can be issued. Then the factory will be inspected to ensure that it is qualified to produce medical equipment.
They did not stop auditing the factory because of the epidemic, and still audit the machines and factories every year to ensure that everything meets the standards.
Also during the epidemic, medical CE issued new regulations, adjusting from MDD to MDR. Currently, MDD is still valid, but if you apply for a new medical CE, you must only apply for MDR. This difficulty is unprecedented and it takes at least 18 months, if everything goes well.
This is the difference between FDA and medical CE. Their strictness and difficulty are very different, and their supervision of factories is also different. FDA has almost no supervision, while medical CE is becoming more and more stringent
Although you recognize FDA, I suggest you also refer to medical CE to review the professionalism of a factory.
There is a big difference between FDA and medical CE in terms of rigor
During the epidemic, since many people applied for FDA, FDA opened a fast track. As long as you submit information and submit an application, you can usually get FDA. Before the epidemic, FDA would come to China for surprise inspections, but now it is no longer the case, so this is why even many trading companies have obtained FDA, and some professional customers dare not rely solely on FDA.
Medical CE is different. It is very strict and difficult when applying, and the cycle is very long. The machine must be sent to a compliant testing agency for strict testing before a report can be issued. Then the factory will be inspected to ensure that it is qualified to produce medical equipment.
They did not stop auditing the factory because of the epidemic, and still audit the machines and factories every year to ensure that everything meets the standards.
Also during the epidemic, medical CE issued new regulations, adjusting from MDD to MDR. Currently, MDD is still valid, but if you apply for a new medical CE, you must only apply for MDR. This difficulty is unprecedented and it takes at least 18 months, if everything goes well.
This is the difference between FDA and medical CE. Their strictness and difficulty are very different, and their supervision of factories is also different. FDA has almost no supervision, while medical CE is becoming more and more stringent
Although you recognize FDA, I suggest you also refer to medical CE to review the professionalism of a factory.