Medical Device Regulations, India: Recent Important Updates

May 30 , 10.00 am Indian Standard Time

Webinar by Seema Dutt

About the Webinar

Medical devices in India are overseen by the Central Drugs Standard Control Organization (CDSCO) which was established under the Drugs and Cosmetics Act of 1940 to regulate the importation, manufacturing and distribution of drugs, medical devices/IVD, biologicals & cosmetics in the country. Over the last few years, a series of Amendments to the Drugs & Cosmetics Act of 1940 has led to better clarity on the registration process and at the same time progressively increasing the coverage scope for Medical Devices. In this journey of continuous strengthening of the Medical Device Regulations, the recent notifications from CDSCO, announced on 11-Feb-20, is a major landmark for the medical device regulations. The notifications introduce rules, specifically called the Medical Device   (Amendment) Rules 2020, effective from 1st Apr 2020 to regulate all Medical Devices by adopting a definition for Medical Devices. In this webinar we present what the notification proposes, including the registration steps involved, the timelines and the impact. This may be particularly useful for medical devices companies/manufacturers which are currently operating in India and those planning to enter the Indian market in the near future.

About the Presenter 

Seema is a B.Pharm & M.Pharm from Mumbai University with 20+ years working with the Medical device and Pharmaceutical industry in the areas of regulatory affairs, quality assurance, clinical trial coordination, pharmacovigilance and technical documentation. In 2011 she started her own

consultancy firm “Regulatory Solutions India” and since then has helped clients from more than 10 countries to register 300+ medical devices across 16+ categories.

Prior to 2011 she has worked with organisations like Pharmacia Upjohn, Johnson & Johnson and Bausch & Lomb in their Regulatory Department.  Her past work experience in these firms has helped her develop knowledge of current Indian regulations, regulatory compliance, quality.