How to handle the registration of Class II medical devices in Shenzhen_
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Which ones are there? How to handle the registration of Class II medical devices in Shenzhen_
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Which ones are there? The country also attaches great importance to the medical device industry.,The upgrading of medical devices has also stimulated fierce competition.。The market entry threshold for the medical device production industry is still relatively high.,But the business is different,Generally, it can be operated。
今天港信通-就给各位想要入行的老板讲讲深圳二类医疗器械备案的一些办理
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。 The classification of medical devices has been discussed many times before.,I won’t go into details here.,Category II only requires business registration of medical devices,It sounds different from a medical device business license,In fact, the materials and procedures are pretty much the same.。
Let’s talk about it first
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Bar,Engaged in medical device business industry,First there needs to be someone,Engaged in the operation of Class II medical devices,Although the entry barrier is low,But people in related industries must have,This is a necessary condition。
There is actually a dispute about the number of personnel,Some people say three people,For some, just say one.,How do you say this?,In fact, it depends on the actual handling situation,if you only have one person,In the process of processing,The teacher asked you to call three people over for an interview.,how do you say。In short,It’s always right to find a few more people.,And it will be faster to get approval.。
In addition, you should pay attention to this issue when interviewing personnel.,Dealing in medical devices,Everyone needs to be interviewed,At least you need to know the model number of your product,use,Maintenance etc.。 Another point is the product registration certificate.,There are some black shops now,Sell some informal and low-priced products,In fact, some people actually buy it。
这里港信通-要告诉大家了,Companies that operate medical devices must provide product registration certificates for the products they operate.,This is also a necessary material for filing Class II medical devices.。Only formal and qualified manufacturers will have this thing,Therefore, this is also something that dealers need to pay attention to when choosing manufacturers.。Only manufacturers with product registration certificates and medical device production licenses,Only wholesale products are qualified。
It can also be sold with confidence。 The last thing is the address.,This is also a controversial point,Some say it's more than 40 square feet.,Some say it's seven to eighty square meters and more than a hundred square meters.。
根据港信通-的经验来看其实面积大一点最好了,If it's bigger, there's room for change.,Processing of Class II Medical Device Registration,The teacher will also go to survey the site.,Once you feel something is inappropriate about you,city
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changed,Then submit new drawings,The teacher will review it again,Confirm that there is no problem,Issue a second-class medical device business registration certificate。
Shenzhen Class II Medical Device Registration Processing
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Here are some of them that I will introduce to you.,Interested friends can pay attention to learn more,If there is anything you don’t understand, you can leave a message below.。
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