MUMBAI
Bhumika Sehgal
Regulatory Specialist
B.A. LL.B (Hons), LL.M (Corporate Laws)
Bhumika is an expert in medical device regulations and is sought after for her deep understanding of regulatory systems and processes.
Biography
Bhumika is a trained legal and regulatory professional with diverse experience in handling licensing and registration applications for a wide array of health-focused businesses, including import and manufacturing activities for medical devices and cosmetics.
Areas of expertise
- Medical Devices
- Environment
Achievements
- Preparation of import licence applications, price-control registrations, and Conducted regulatory due diligence for hospitals.
- Appearance before various regulators such as CDSCO, NPPA, LM, CPCB, MPCB and has gotten solutions for Client in complex matters.
- Preparation of technical documentation for submissions to Indian regulatory authorities, including Plant Master Files and Device Master Files for medical device companies, and has advised hospitals on various regulatory compliance requirements.
- Advice on the regulatory pathways for the import of accessories and software as medical devices, including risk classification and predicate analysis. Her experience also extends to WPC-ETA approvals, ensuring seamless imports for devices requiring wireless authorizations.
Professional memberships
- Bar Council of India
Recognition and rewards
- Thomson Reuters Best In-House Counsel
- Chambers Ranked Firm
Publications and presentations
- Conducted HR Sutra Digital Master Class on EPR Framework
- In-Person Training on Biomedical Waste Compliances