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400-0569-812
400-0569-812
Help you quickly start the compliance journey of medical devices
International Projects China Project Surrounding the project
Us agent, FDA registration, 510(K) registration, Food and contact product registration
European Union authorized representative, European Union certification (CE certification), European Union free sales certificate
ISO9001, ISO13485, QSR820, MDSAP single audit
UK UKCA, Canada HC, Japan Regulations, Brazil ANVISA, South Korea KFDA
Obtain the market access in China according to the medical device registration supervision requirements of China Food and Drug Administration
Obtain the state license and carry out the production operation legally
Under the leadership of senior people in the global market compliance business, we have nearly 20 years of experience in the complex market compliance consulting field and are committed to benefiting more customers.
About usCompliance business expert
Customer service experience
Customer product compliance
Annual business operation volume
FDA certification is mainly divided into "FDA registration" and "510K certification" Only FDA registration is requ
1 The business license has been over 3 months2 Manufacturing enterprises
1 Copy of business license2 Copy of license qualification, etc [If required by enterprises with production lice
1 First sign a tutoring contract After we receive the first one, the tutor will go to the door for on-site
1 Simple guidance type: single system 1 months or so, double system 1 5 half or so, three system 2 months or
The certificate is valid for 3 years In addition, the certificate shall be supervised and reviewed every year
1 Improve the brand value of the company externally and enhance customer satisfaction with your company Internal
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