The Drugs and Cosmetics Act, 1940, has been governing drugs and medical devices since 1940 and has received multiple iterations each year. Owing to the significant changes that have occurred in the...

What is a medical device? A medical device is any product that is intended to be used alone or in combination with another product, in the diagnosis of diseases or in the...

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...