The Central Government of India defines a Medical Device as a medical instrument for external or internal use in the prevention, diagnosis or treatment of a condition or disease. It also includes...

With rapidly growing digitalization in the world of healthcare and its accessory outfits, the Indian Government has chosen to join the foray and ride the digital wave. As part of implementation of...

  National List of Essential Medicines The National List of Essential Medicines (NLEM), 2011, has been reviewed and revised by the Core-Committee constituted by the Ministry of Health & Family Welfare (MOHFW),...

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...