Based in Shenzhen,Serving the Greater Bay Area
Your trustworthy enterprise qualification consulting expert

Medical device license application process and price

The medical industry has always been controversial,But regardless of whether it is controversial or not,This industry really exists。

Medical devices are divided into categories,Category II,Category three,Recently, the editor learned that some friends who are new to this industry are not very clear about the specific classification of medical devices.,Therefore, I don’t know whether I need to apply for a medical device business license.,Class II medical device business record,Welcome to consult Hong Kong Xintong Medical,We specialize in providing medical device technical consulting services to medical device production and operating companies.,Medical device license

Application process

and price. Today, the editor will tell you about the conditions for applying for a Class II medical device business license.。

Medical device license

Application process

and price venues

Require

:Equipment class:60Square meters of office、Warehouse 20 square meters。Class III:6822、6823、6824、6825、6826、6828、6830、6831、6832、6833、6840、6854、6858、6870Select product。1 person with diploma in quality management,Medicine or nursing major,3years of work experience。

Dressings and Disposable Steriles:Office 60,Warehouse 80 square meters。Class III:

  1. 6866。2 people with diploma in quality management,Medicine or nursing major,3years of work experience。Implants:Office 100 square meters、Warehouse 40 square meters。Class III:
  2. 6877。1 person with bachelor's degree in quality management,Medicine or nursing major,3years of work experience。

diagnostic reagents:Office 100 square meters,Warehouse 60 square meters,Adding a consumables warehouse of 96 square meters,Cold storage 20 cubic meters。Cold storage verification report,Dual refrigeration unit,Dual power supply system,Corporate college degree,4 people,Supervising Inspector,inspector,medical staff,Medical device license

Application process

and price。

If the preparation time and rectification time are not included, the review time alone will take 45 working days, or one and a half months.,If the preparation time, rectification and re-audit time after rectification are calculated, it will be longer.,If technical ability is insufficient、Lack of thorough understanding of laws and regulations、Insufficient information preparation、The combination of factors such as incomplete rectification will greatly extend the period or even lead to failure of approval for up to one year.。

What usually happens is that companies still don’t know where the problem lies after failing the audit.,Or I don’t know how to rectify it, so I have gone through a lot of mistakes.,It consumes a lot of manpower, material resources and time costs。The processing time at Hong Kong Information Network will be greatly shortened.,Class II medical device registration is issued on the same day,Class III medical device business license conditions will be issued 15 working days after submission of the conditions for review,But full refund!Ingenuity,Craftsman's heart。

Make service the best,Regard service as the source of life,Focus on listening to real sounds,Try to solve every problem,Medical device license

Application process

and price。The content of this article is strictly prohibited from being reproduced by any website or individual.,Violators will be prosecuted。Related products:Medical device transfer , Medical device registration , Apply for medical devices


About Hong Kong Xintong

Hong Kong Xintong focuses onGuangdong and Hong Kong license platesShenzhen Hazardous Chemicals Business LicenseShenzhen labor dispatch licenseandShenzhen Charity Foundationapplication services,Assist customers to applyShenzhen travel agency business licenseShenzhen pawn shop business license、Shenzhen auction house license and other mainstream domestic financial licenses,Support enterprises to achieve compliance expansion of cross-border financial business。Also availableODI overseas investment registration、International travel agency registration and other services,Help enterprises expand their presence in international markets。Provide one-stop compliance solutions for enterprises。To learn more,Please contactHong Kong Information Communications Consultant

No reproduction without permission:Port communication » Medical device license application process and price

Port communication,Your Guangdong-Hong Kong-Macao Greater Bay Area qualification agency expert。

Phone/WeChat 134 170 46218WeChat QR code