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The domestic first-class medical device registration approval process 2022-03-24
The domestic first-class medical device registration (re-registration) consists of acceptance and administrative approval. Th...
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The first registration of domestic third-class medical devices 2022-03-24
The first registration of domestic third-class medical devices I. Project Name: Registration of Domestic Medical Devices II...
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Medical Device Registration 2022-03-24
Basic information editingMedical device registration is a process in which the Food and Drug Administration, according to the...
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Medical device CE certification technical documents 2022-03-24
"Technical documentation" is a very important item in the EU Medical Device Directive. Its purpose is to require en...
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Medical Device CE Certification Risk Management 2022-03-24
Failure Mode and Effects Analysis (FMEA) Failure Tree Analysis (FTA) Monitoring after listing (customer complaints, etc.)...
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FDA registration related regulations 2022-03-24
FDA-related regulations The US decrees related to the management of medical devices mainly include the following three:*The F...