Development of
Regulatory Strategy
India medical device regulations have gone through major overhaul during last few years with the implementation of separate Medical Device Rules under Drugs and Cosmetics Act, 1940. Further, India authorities have adopted a medical device definition effective from 1st April 2020 to transition from notified device list to a definition-based regulation. These regulation changes permit the phase-wise transition in order to regulate all devices in India. In this complex and dynamic environment, it is of paramount importance to adopt the right strategy in the beginning of project. With the help of our expertise, we can assist you in developing the right regulatory strategy for your projects.
Medical Device
Registration Process
In addition to regulatory strategy, we can assist you with device registration process in India including risk classification, gap analysis, dossier compilation, submission to authorities and response to queries raised by authorities.
License Maintenance for
Post Approval Changes
A medical device goes through multiple changes during the complete life-cycle. Even if device is approved in India, it is important to maintain license by taking appropriate license amendments for post-approval changes as per regulations. We can assist you with change assessment with respect to regulatory impact, submission and approval process to amend licenses for major product changes.
Product Portfolio Analysis
While regulations are undergoing major changes to regulate all medical devices in India, we can
assist you with full product-portfolio analysis and guide your next steps to achieve compliance
with phase-wise transition permitted in regulations.
Post-market Adverse
Event & Recall Reporting
We can assist you with timely reporting of adverse event and field corrective action to authorities in the prescribed reporting forms.
Regulatory
Intelligence Updates
Regulatory environment is changing fast with major developments happening in short period of
time. We can partner with you to provide regular updates on regulatory environment or resolve your specific queries on different aspects of regulation. We can also support you with impact assessment of regulation changes specific to your product portfolio and assist you in developing compliance mapping products.
Training on India
Device Regulations
We can develop training program to train your in-house team on current regulatory requirements with the help of easy-to-understand case studies.