Manufacturing medical devices are challenging, and maintaining their quality, managing certifications, and meeting regulatory requirements is even more demanding. Managing all these aspects simultaneously can be overwhelming.
That's where our regulatory services come in!!
We are here to make it easier for you to comply with regulations and streamline regulatory processes!
About RIFC
The Regulatory Information and Facilitation Center (RIFC) is a joint initiative of the Venture Center and BIRAC under the BIRAC Regional Bio-Innovation Center (BRBC) program.
We at RIFC aim to assist bio-entrepreneurs/MedTech Startups in planning, seeking and securing regulatory approvals. We plan to achieve this by providing information in an entrepreneur-friendly manner, providing access to experts and regulators, providing access to practical insights from other entrepreneurs, providing services and organizing relevant and useful events.
Services We Offer
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Indian Market |  |
European Market |
US Market |
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Key Resources
- 26 National/International Standards (E.g. ISO 13485, ISO 10993)
- 150+ ISO 13485 QMS Templates
- 180+ Dossier Templates (For India and EU regulations)
- Database of the Testing Labs and Certification Bodies*
Key Activities
- R-Clinic (Regulatory Clinic)
- Workshops
- Base camp focused on regulatory approval
- Annual Conference
Activities Gallery
Client Testimonials
1. |
RIFC centre has helped us to: Know the regulatory status of our product. Provided the format for the application of NOC. We have confidence in the team that they are capable of providing an accurate and detailed analysis and guidance in regulations for medical devices. Dr Lavkesh Bansal , Dzeal Pvt Ltd , 17-Dec-2018 |
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BRBC at Venture Centre has been an extremely helpful mentor in guiding us on how to go about taking regulatory approvals for our medical device. From a point of us being unaware of what to do, Navnath brought us to a point where we could confidently go to CDSCO and get our work done. Thank you very much, Navnath! Malay Dikshit , MD& CEO , Piscium Health Sciences Pvt Ltd , 18-Dec-2018 |
3. |
RIFC has been a valuable resource for us to navigate the complex world of medical device regulations. They have provided detailed guidance on the regulatory pathway to be followed for our products. They have also worked with us on our various regulatory license applications and have guided us on how to respond to queries received from the regulatory authorities. We are fully confident that RIFC will continue to play a crucial role in helping us to shape a successful regulatory strategy for our products." Hope this helps. Dr. Nilay J. Lakhkar , Founder and CEO , SynThera Biomedical Private Limited , 16-Jan-2019 |
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Venture center itself is playing great role in nurturing and shaping up the start up in their not so easy journey. I am thankful for all the support provided and recently I had an interaction with Mr. Navnath (RIFC-BBRC) regarding regulatory requirements for the devices we are developing. I would say it was really very informative and helpful for us to streamline our work as per the regulatory guidelines and certification required. A big thank to Navnath for his valuable inputs." Dr. Preeti Joshi , Fastsense Diagnostics Pvt Ltd , 16-Mar-2019 |
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I especially want to thank Venture Center and RIFC staff for starting this service. The regulatory environment in India is changing and startups need to be updated on the latest regulations. RFIC has helped us in planning our regulatory compliance pathway. Tanuj Gigras , Co-Founder & Director , Nayam Innovations Pvt. Ltd. , 23 Jan 2019 |
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Venture Center's RIFC team headed by Navnath has provided tremendous clarity in regulatory guidance for medtech startups at a time when new regulations like MDR are being rolled out in India. Right from communicating the various notifications released from time to time to the various initiatives like regulatory training workshops, expert talks, and one-to-one advisory services, RIFC has deep expertise in the entire process. Navnath always gives well-studied and actionable insights and advice which we can act upon- a truly tangible value add that any startup looks for in the ecosystem. Aniruddha Atre , Jeevtronics Pvt Ltd , 24-Sep-2020 |
Our clients
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