The matter has been under consideration since 2018, when, during the meeting of the India-EU sub-commission on trade, the EU officials said that for the regulation of new products, the new regulations stated that clinical investigation may not be required to be submitted where the investigational medical device is approved by the regulatory authorities of the US, UK, Australia, Canada or Japan, but did not include the EU, as per Rule 63(1)., The matter has been under consideration since 2018, when, during the meeting of the India-EU sub-commission on trade, the EU officials said that for the regulation of new products, the new regulations stated that clinical investigation may not be required to be submitted where the investigational medical device is approved by the regulatory authorities of the US, UK, Australia, Canada or Japan, but did not include the EU, as per Rule 63(1)., , Read More
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