Medical equipment business license is a medical equipment business enterprise must have a document, have this document to legal compliance with the hospital business cooperation. Although many business owners are aware of the need for this qualification, but how to handle, the process will encounter what problems are not very clear. I'm going to talk about it.
Q1, medical device license where to apply?
The Food and Drug Administration in the region where the enterprise.
Q2, medical device license is valid for how long?
The Medical Device License is valid for 5 years.
Q3, how to determine what type of medical device is applied for?
This needs to look at the medical device product packaging labeled registration number, the first number of the XXXXXXXX number is the management category, 1 is a class, 2 is a class II, the registration number is generally arranged as follows: × (×) 1 (food) Drug Supervision and Inspection of the mechanical (× 2) word ××××3 No. × 4 × × 5 ××××6 number.
After the introduction of the basics of medical devices, that will encounter trouble in the process and how to avoid.First of all, the medical device license is required to have a registered address to deal with. According to the law, the medical device business license business registered address and the actual business address must be the same. The validity of the medical device business license is 5 years, so when the time to apply for must take into account the duration of the use of the address, while the use of this address need to be compliant with the management, according to the year for the annual inspection, so in the process must cooperate with the validity of at least 5 years of the address, do not want to be cheap, so that there is no worry!
Secondly, the medical device business license must have a professional staff allocation, full-time, otherwise it can not be processed. In particular, quality management personnel, which plays an important role, not part-time. For medical device license personnel problems, this can only be solved by themselves.
Lastly, for medical equipment business license must have an address, but not all addresses can be used. The license has strict requirements for the registered address. The registered address for the medical device license must be a commercial address, and at the same time, the area of the address is also required, the minimum in the Shanghai area can not be less than 45 ㎡ , compared to other parts of the country, the threshold is relatively low, the requirements for different categories of medical devices on the address vary.
In addition to the above three traps, about the medical equipment business license for the product authorization documents also need to pay attention. This document must also be provided by the enterprise itself, the document directly to the corresponding manufacturer can be.
These are in the process of licensing need to be careful and prudent place, I hope to help you, do not understand can always consult me.