CDSCO or Central Drugs Standard Control Organization, the authority that regulates medical devices regulation India released two draft notices on September 3, 2020. The draft notification includes the classification of non-notified medical devices and in-...
MakroCare has strong presence in the European market with local affiliates as well as an exclusive delivery center in the United Kingdom (UK). MakroCare covers the entire spectrum of Regulatory support services for medical devices in order to market produ...
MakroCare global regulatory experts welcome the opportunity to discuss strategic options related to the new EU MDR and IVDR regulations, including the critical steps you should be taking now to realize successful outcomes
The guidelines are concerned with an application for a license to import or manufacture for sale or distribution, sale, stocking, or offer for sale or distribution of medical devices under Medical Devices Rules, 2017.
Medical Devices have always been an object of concern and regulation by the Indian Government. With advancing medical technology and the exponentially rising need of medical devices in the country, new reforms and rules have come into effect.
Oxytocin, which is a neurotransmitter and a peptide hormone are being greatly misused in the diary and the horticulture industry. Oxytocin is also called love hormone which is often released when people cuddle or make bonds socially.
With increasing UV radiation exposure, there is a growing evidence of several skin diseases like early ageing, disorders and even cancer. The skin disorders occur by UV exposure because of inflammation, oxidation, stress as well as DNA damage.
The update/amendment in the Medical Device Rules has paved the way for the implementation of eIFU with the medical devices. These new procedures will have certain advantages and disadvantages, but it will help the medical device industry for sure.