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
