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Understanding Medical Device Registration & Its Importance
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Amidst all the chaos of a medical emergency, the only thing that helps save a life are the medical instruments. Such is the power of these small tools that millions of lives are saved every day. Other than the use in medical procedures, there are devices used for day to day regular uses as well.
However, have we ever paid attention to these small things that come to the rescue in difficult situations? The answer sadly was a no just a few years back. Only a small margin of items being used were tested. It was only the devices like syringes, tubal rings etc. that had to pass a certain set of standards according to the set rules and regulations. Over time, the need for regulating other devices was observed and as of now, most of them are under strict laws which has turned out to be beneficial and more helpful for the citizens.
Such rules for medical device registration in India, have changed the entire scenario and created an even more protected environment where people can trust the medical devices and kits they use.
Although this has proved beneficial for general public, the companies entering the Indian market, have to deal with a lot of paperwork and set procedures before making a final presence. The procedure is lengthy which in turn requires special attention and therefore what comes in play, is the need of regulatory consultants.
Regulatory consultants have people with all the technical knowhow and can help the companies with all the required work. From step one to the last, it is made sure that the company launching its products is well taken care of with all the formalities. They are also responsible for preparation and timely submission of all the documents pertaining to the requirements. It is not wrong to say that the regulatory consultants take care of their clients like a new born baby and make sure that they deliver the best.
In case you're left wondering how and what exactly will these consultants do to help you establish your business in the Indian market, following is a detailed description of what all you should expect.
Understanding the products and then developing proper regulatory strategies to ensure that the promise of executing the project can be fulfilled.
Preparing dossiers free from any kinds of ambiguity or query.
Robust follow ups at CDSCO after successful dossier submission.
Assistance in MDAC/SEC meeting for devices.
Import and registration of medical devices
Test licence for medical device
Import Licence for Non- notified IVD Products
Manufacturing licence for medical device
Clinical trial approval for medical devices
CliniExperts, the well known Pharma regulatory consultant. To know more about medical device registration in India and Manufacturing licence for medical device. visit online - http://cliniexperts.com/
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