Compulsory Registration in India for All Foreign and Indian Medical Device Manufacturers
Effective From 1st October 2021, Every Foreign Company, Indian Importer and Indian Manufacturer who sells in India or wishes to sell Medical Devices in India, must have Compulsory Registration
Import Registration
In Order to Sell the Medical Devices Manufactured Outside India, there is a need to have Import Registration with CDSCO.
CE Marking
We have Experienced and Enthusiastic Professionals that support your organization to get CE Certification
Quality Assurance
ISO Certification-13485:2016 / EN ISO 13485:2016, MDSAP. Our Experienced & Enthusiastic Team of Professionals can support
Manufacturing License
Our Experienced and Enthusiastic Team of Professionals can support your organization to get Manufacturing License
US FDA Approval
The US FDA has classified the Medical Devices as Class 1 devices, Class 2 devices and Class 3 devices
Regulatory Software & Services
Medical Device manufacturer companies have to create and maintain the UDI
Facility Designing
We have Experienced and Enthusiastic Professionals that support your organization to get CE Certification
Document Drafting
We at DKNSB provide you Technical Document Service of Risk Analysis as per ISO 14971:2019, Clinical Evaluation
Objective
Hassle-Free Regulatory Approval for Indian Manufacturers, Foreign Manufacturers and Importers of Medical Devices.
Achievements
DKNSB Medical Device Consultants is backed by 20 years of experience with the aim to provide Technical and Regulatory Support to Medical Device Manufacturers from India and Overseas.
Connect With DKNSB
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Get in Touch With Us.
Interested in working with us? we’re always happy to chat.
For Inquiries: +91-98711-93930.
