End-to-End Regulatory Compliance for Medical Devices, Cosmetics, and IVDs in India
Ensuring Regulatory Compliance for a Safe and Efficient Market Entry
- info@regulatory-solutions-india.com
- 0120-4986832
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Hear from Our Satisfied Clients
"We had an outstanding experience working with Regulatory Solutions India. Their expertise in MDR and CDSCO was evident from day one. They took the time to understand our concern and implemented proactive solutions that significantly enhanced our capabilities. The level of professionalism, responsiveness, and in-depth knowledge they provided was exceptional. We highly recommend their services to any organization looking to strengthen their MDR and CDSCO compliance."

"I have worked with RSI for medical devices (IOL & Equipment) registration and marketing authorizations in India. The RSI team has an excellent knowledge base and really know the ins and outs of the India Regulatory scene and working with Indian CDSCO. I would highly recommend them as their work is detailed, fast and very thorough. Their regulatory work from a consulting standpoint is the best I have seen and worked with for registration needs in India."

"RSI has assisted us with many medical device registrations in India along with other regulatory compliance consulting and guidance. RSI team has provided us with excellent service to help access the Indian medical device market. The team is very knowledgeable, patient, hardworking and provides competitively priced services. I highly recommend them to any medical device companies that require regulatory guidance or assistance to access the Indian market. "

“RSI is a real asset to have as part of the team when applying for Product Registration and for other advice on the Regulatory Environment in India. The team is very experienced and keep themselves updated with all the latest developments. Their professional approach & setting of clear-cut guidelines was very helpful in managing expectations and timelines. We had the pleasure of dealing with RSI for registering a UK based MNC's products in India which went off in a smooth manner and at all times all concerned stakeholders were constantly updated till the registration came through. Would strongly recommend team RSI for seeking advice / support regarding all Regulatory aspects in India.”

"RSI has been an excellent regulatory service provider to us for all our registration needs in India. The RSI team keep themself abreast of legislation & guidelines. They are excellent in collating and evaluating scientific data which helps them propose clear arguments and explanations for new product licenses/ renewals. In all our dealing they have always superseded our expectation when it comes to providing strategic advice to senior management throughout the development of a new product. We wish RSI team the very best for current & future endeavors !!"

“Regulatory Solutions India has been a trusted partner in navigating the complex regulatory landscape for medical devices. Their expertise in CDSCO registrations, Legal Metrology compliance, WPC, and BIS certifications has been invaluable in ensuring smooth approvals and post-market compliance. With their in-depth knowledge and proactive approach, they have consistently supported businesses in meeting regulatory requirements efficiently. I highly recommend their services for seamless regulatory support in India.”

“We truly appreciate RSI’s accurate and prompt support, which is always a great help to us.
RSI’s extensive knowledge and expertise consistently provide us with valuable and insightful advice."
Yuka SumidaJ. MORITA CORP., JAPAN
"The RSI team is extremely competent in the field of medical device registration and approval for the Indian market. They are always available for questions and able to present solid solutions for complex challenges. Highly recommended !"
Jens MeyerRegulatory Affairs Manager Olympus Surgical Technologies Europe
Why RSI?
When it comes to choosing a regulatory partner, clients like you need somebody who has a strong understanding of the country’s regulatory framework, a variety of products experience and a sense of urgency to deliver. We let our numbers speak to reflect these strengths of ours:
Our unique strength
Our rich experience ensures that RSI offers a unique blend of technical, strategic and project management support in all assignments.

Categories of devices registered
- Ophthalmic
- Neurological
- General Hospital
- Dental
- Respiratory
- Ear, Nose and Throat (ENT)
- Obstetrical and Gynecological (OG)
- Software
- Operation Theatre (OT)
- Gastroenterological
- Oncology
- Urological
Served clients from 20+ countries with a 100% repeat business.
