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Establishment Registration & Device Listing
Foreign companies who are involved in manufacturing of medical devices are required to register their facility, pay registration fees, and list their devices with the local government adminstration
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International Agent
The agent acts to communicate between the internaltional local government adminstration and the foreign company. All important regulatory communication, such as compliance issues, product related problems or inspection schedules, will come through the agent.
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Fast Service
Focus on what you do best: your business. Leave the compliance to us. Our regulatory experts will quickly complete your required registrations properly.
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Multilingual Customer Support
Regardless of where you are at, our global team of multilingual Regulatory Specialists can help your company comply with local government adminstration regulations
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Renewal
In the ever changing regulatory landscape we offer an easy and efficient one-stop renewal process.
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Ongoing Partnership
We have very high customer retension rate and pride ourself in excellent customer service satisfaction. Our company attracts new partnerships through word-of-mouth and industry reputation
With the spread of the new coronavirus variant strain Omicron, many countries are widely using COVID-19 self-test kits. This kind of testing kits that can be tested at home and the results can be known immediately were once in short supply. There are many rapid antigen test kits for the new crown are made in China, also the testing sensitivity is very stable. PureFDA a global regulatory medical device consulting company which provides expert advice on global regulatory requirements for medical devices. Our complete solution will give you the support you need until you have met regulatory compliance requirements prior to commercial distribution worldwide.