The medical device industry is growing extraordinarily, becoming one of the most promising sectors for businesses in healthcare. At the same time, the safety and efficacy of medical devices is highly critical because of their role in diagnosis, prevention, and treatment of disease.
We are an authorized agent for medical device registration in India, with in-depth knowledge of local and international regulations. Resolving challenges with regulatory authorities for medical devices can be complex — but with the right guidance, it becomes straightforward. Connect with us today to simplify your registration journey.
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We provide complete support and guidance for medical device registration in India, ensuring regulatory compliance with quality and safety standards — from initial classification to securing your registration certificate:
We help clients identify the class of medical device (A, B, C, & D) based on potential risk and intended use, ensuring precise regulatory compliance with local and international regulations
Technical documents covering manufacturing process, quality documents, process control, and safety of the medical device — prepared to meet CDSCO requirements for all device classes
Preparation of both clinical and non-clinical evaluation reports for all classes of medical devices, demonstrating the performance of medical devices and in vitro diagnostic (IVD) devices
ISO 13485 compliance is a prerequisite for medical device registration in India. Our experts provide guidance and support in preparing for QMS audits, ensuring your processes meet regulatory standards
We handle regulatory submission of documents for product registration to the Central Drug Standard Control Organization (CDSCO) and ensure timely follow-up for seamless approval
Once the process is successfully executed, we guide you through obtaining the registration certificate, enabling your product to gain market access on time and avoiding any unnecessary delays
CDSCO is the regulatory authority of India responsible for regulation of medical devices, pharmaceuticals, cosmetics, and more — safeguarding public health by ensuring every device is thoroughly evaluated for safety and efficacy before market access:
End-to-end management of the medical device registration process with CDSCO, covering all device classes (A, B, C, and D) including diagnostic devices, surgical instruments, implants, and in vitro diagnostic (IVD) devices, ensuring timely and compliant market authorization.
Preparation of Device Master Files (DMF) and Plant Master Files (PMF) with full regulatory compliance, ensuring all manufacturing and product information is accurately documented and presented to CDSCO in the required format for efficient review and approval.
Expert assistance with SUGAM portal registration and online submission of medical device applications to CDSCO, ensuring accurate data entry, document uploads, and compliance with all portal-specific requirements for smooth and error-free processing of your application.
Support for obtaining manufacturing licenses for Class A, B, C, and D medical devices, including preparation of all required documentation, facility compliance guidance, and coordination with state drug authorities and CDSCO for timely license grant.
Comprehensive support for obtaining import licenses for medical devices, managing all documentation and submission requirements for foreign manufacturers seeking to import their devices into the Indian market in compliance with CDSCO regulations and MDR 2017 requirements.
Assistance in obtaining test licenses for investigational or research-stage medical devices, enabling manufacturers to conduct performance testing and evaluation in India in full compliance with applicable regulatory requirements before proceeding to full registration.
Simplify your medical device registration process in India with our expertise and qualified team of regulatory professionals:
We are an authorized agent for medical device registration in India, with official recognition to represent foreign and domestic manufacturers before CDSCO — providing you with credible, accountable, and legally compliant regulatory representation throughout the registration process.
Our team brings in-depth knowledge of both Indian regulations (MDR 2017, CDSCO guidelines) and international standards (ISO 13485, IEC 62304, CE marking, FDA), helping you navigate the full spectrum of regulatory requirements for domestic and global market access.
With our expert guidance and structured approach, we help you meet all regulatory standards efficiently, bringing your medical device to local and international markets faster and improving the quality of care worldwide through timely access to safe and effective devices.
Find answers to common questions about medical device registration and our support services.
Contact UsMedical device registration is a legal and regulatory requirement that ensures every device available in the market is safe, effective, and of acceptable quality. Registration is necessary for the following key reasons:
Medwisdom Lifescience guides manufacturers through every step of the registration process to ensure full compliance and timely market access.
The documents required for medical device registration in India with CDSCO vary by device class but generally include:
Medwisdom Lifescience assists in preparing and compiling all required documents to ensure a complete and compliant submission to CDSCO.
The timeline for medical device registration with CDSCO in India varies depending on the device class and completeness of the submitted dossier. Approximate timelines are:
These timelines can be significantly affected by the completeness and quality of the submitted documentation. Medwisdom Lifescience ensures thorough dossier preparation to minimize queries and avoid delays in the registration process.
Yes, foreign manufacturers can register their medical devices in India through CDSCO. However, there are specific requirements that foreign manufacturers must fulfill:
As an authorized agent for medical device registration in India, Medwisdom Lifescience provides complete support to foreign manufacturers for obtaining all required licenses and registrations from CDSCO.
