The Central Drugs Standard Control Organization (CDSCO) plays an important role in safeguarding and enhancing public health by ensuring the quality, safety, and efficacy of drugs, cosmetics, and medical devices. It is...

In order to strengthen the scientific review and approval of new drugs/devices, the ministry has appointed 12 New Drug Advisory Committee’s (NDAC), Subject Expert Committees (SEC) and 7 Medical Device Advisory Committee’s...

  Regulatory Affairs at US-FDA  Drug & Medical Device Regulatory Consulting CliniExperts have aligned themselves with the internationally renowned regulatory consulting companies. These companies have a proven track record in drug, medical device, and regulatory consulting...

  Presently, the Indian market for medical devices is largely unregulated. Medical devices are freely imported into India. Only certain products require medical device registration in India. Over the years, there have...

The clinical trial of Medical Device is different in nature as compared to that of Drugs or vaccines. In case of Medical Device, they do not conduct Phase I clinical trial to...

  By Jill Hartzler Warner, J.D.   The U.S. Congress and the Food and Drug Administration have long focused on bringing new therapies to patients with rare diseases, including children. Two years...

File No. 29/Misc/3/2012-DC (169) 8th Jan 2013 Medical devices which are notified under the provisions of Drugs and Cosmetics Act 1940 requires Registration certificate in Form 41 and Import Licence in Form...