1. Create a medical device company - first you have to be a company, then, two certificates and one license is indispensable
Business license, organization code certificate, tax registration certificate - any company has to have
2. Apply to the Drug Administration for a Medical Device Business License, specific steps, call and ask them.
This process can be long (for reasons you know ......), there are a lot of hard and fast rules. For example, the business premises can not be in residential buildings or living areas, the area of the premises, and even the area of the warehouse, the warehouse side of the display of furnishings (and even require to be placed inside the mouse traps). Operating disposable sterile instruments (three categories), the warehouse area requirements are higher, in vitro diagnostic reagents, but also cold storage ...... are almost accurate to the single digits. And also your rental contract or something.
Personnel, there are also a lot of requirements, the person in charge of the enterprise, quality management (Xinjiang: medical device-related professional college or above), after-sales engineers, these three people can not be part-time, that is to say, your company should have at least three people. (There are many other things, each region is different, specific to the Drug Administration requirements prevail)
In short, there are two: personnel and site requirements. Oh yeah, and files. I think I remember like 18 files. This system, that system.
3. All finished, let the Drug Administration to check. After the inspection, issue the Medical Device Business Enterprise License - of course it's not issued to you on the same day, even though they have a deadline on that file.
Of course it will not be so smooth - the reason is still the same, you know ......
4. And then die begging, after nine oxen and two tigers, you finally waited for the "License", well , you can open for business (about half a year it)
5. Then four years later, the "license" expires, you should start a new round of tossing ......
------ there are a lot of medical device companies, in a few years a more name, or directly canceled to reopen the new company, not all because of the heart of the ghosts, this thing is enough for you to toss.
6. On the classification of medical devices:
There is only one license, which has a different business scope. Class II/III, generally put together.
One class, two classes, three classes. The requirements are progressively higher. Of course, there is another kind, called "the study decided not to manage the product as a medical device". Pipettes, for example. A class of devices do not need a certificate, but are some worthless things, it is estimated that you sell also suffocated. In vitro diagnostic reagents are class II, but you want to operate it, first of all, you have to have a cold storage, followed by a pharmacist title, but also a specialized certificate, specifically called what I forget, anyway, and a toss ......
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7. dizzy? I said dizzy ...... then tell you the simplest way:
Go to the Drug Administration, take some relations, and then let the other side to find you a person who understands the process, you pay him, he will give you everything to smooth out, you do not have to do the hands of the cabinet on it.
Reason:
1. That person, itself is the people of the drug regulatory system, may be retired idle old comrades, may also be the civil servant's relatives, anyway, the money spent on him, to give him a convenient, the Drug Administration will give you a convenient ......
2. Not to look for him, completely rely on their own! Can it work - I guess it can, but I haven't really seen anyone do it. Consider yourself thinking about these joints for what exactly.
Anyways, just one sentence: the relationship is in place, the relationship is not in place, let the money in place - probably all industries are the same.