Medical Devices & Healthcare
Blending techno-legal expertise in medical devices & equipments sector to provide seamless services to clients
Broadly the legal and regulatory service and assistance provided by the firm in the area of medical devices and equipment are as under:
- Technical and Regulatory services required exclusively for medical device manufacturer.
- Drafting the preparation of all legal and technical documents under one umbrella exclusively for medical device manufacturer,
- Liaison with different Government Authorities in India on behalf of the medical device manufacturer
- Preparation and submission of query response to the clarification letter (query letter) issued by DCGI, New Delhi or other state licensing authority.
- Medical Device Registration in India - Registration Certificate (Form-41), Re-Registration Certificate, Import License (Form-10), Test license (Form-11) for Drugs, CLAA Scheme
- Medical device registration in Europe, US, South Africa, GCC countries, Sri Lanka,
- QMS compliance, ISO 13485 documentation, CE Mark technical support and documentation, Documentation as per US FDA 21 CFR
- Regulatory Consulting
- Technical and Regulatory assistance for CDSCO works
- Assistance for Clinical Evaluation of Medical Devices
- Assistance in appointing EU or US Representatives.
- Review of labels and art work corrections as per Rule 96 of Drug & Cosmetic Act 1940.
- Organised Specialize “training and development plans” for medical device manufacturer
- Conduct Internal Audit – Technical, Regulatory and Legal Compliance
- Acting as key point of reference for all correspondence with regulatory/competent authority - DCGI, MHRA, USFDA, SFDA, NAFDAC, KFDA for all kinds of approval and registration.
- Assistance with DSIR for IRD - R&D approval, Clinical Trials, Govt funding scheme/projects