CDSCO
Trusted CDSCO Medical Device Consultant
Your reliable partner for comprehensive medical device registration, compliance, and market access.
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Medical Device Registration Services CDSCO
Get expert support for CDSCO medical device registration. Contact us for a free consultation call today!
Service
Simplifying Medical Device Regulations
Expert Support for Seamless Market Entry and Compliance Across Global Standards
MD-5 Medical Device License
License for manufacturing Class A and B medical devices.
MD 6 Loan License for Class A or Class B
License to manufacture Class A or B medical devices at a loaned premises.
MD-9 Medical Device License
License for manufacturing Class C and D medical devices.
MD-15 Medical Device Import License
License for importing and distributing medical devices in India.
MD-13 Medical Device Test License
License for testing, evaluating, and training on medical devices.
MD-42 Medical Device Wholesale License
License for selling, stocking, exhibiting, or distributing medical devices, including in vitro diagnostic devices.
Certificates
Certificates for Free Sale, Market Standing, Non-Conviction, etc.
Cosmetic Import License Cos-2
Get a Cosmetic Import License in India with AccordMed. We assist with COS-1, COS-2 registrations, compliance, and seamless approval from CDSCO. Start now!
ISO Certification-QMS
Consultancy for Quality Management System certification, including ISO 13485, ISO 9001, SA 8001, and ICMED 13485 standards.
Test License for Medical Devices in India - Form MD 16 & MD 17
Permission To Import Test License For Medical Devices (Form MD 16, 17)
About
CDSCO Registration
At CDSCORegistration, we bring over 5 years of experience in medical device and cosmetic registration with India’s CDSCO. Our expert team ensures your products comply with both national and international standards, including ISO certifications. We manage the entire registration process—documentation, compliance, and approvals—so you can concentrate on expanding your business.
Successful Projects
Quality Customers
Query Resolved
Unlock Markets, Build Trust, Ensure Safety – Register Your Medical Device Today!
Legal Compliance
Ensure your products meet health regulations, avoid legal troubles and fines, and sell your devices legally
Market Access
Expand your market reach with registered devices, enabling you to sell in more countries and unlock new business opportunities
Credibility and Competitive Advantage
Showcase the safety and reliability of your products, build trust with healthcare professionals and consumers, and stand out from unregistered competitors
Who is Eligible for CDSCO Registration in India?
Indian Manufacturers: Local producers of medical devices and in vitro diagnostics (IVDs) intending to distribute their products within India.
Importers: Entities importing medical devices, IVDs, or cosmetics into India from international markets.
International Manufacturers: Foreign producers of medical devices, IVDs, or cosmetics seeking approval to sell their products in India.
Medical Device registration
Frequently Asked Questions
Medical Device Registration is a regulatory process where information and documents about a medical device are submitted to a government agency or regulatory authority. This process is essential to obtain approval or authorization to market and distribute the device within a specific jurisdiction. Registration ensures that the device meets required safety, efficacy, and quality standards.
In India, medical devices are classified into four categories based on the risk they pose to the patient:
- Class A: Low-risk devices, such as bandages and manual wheelchairs.
- Class B: Moderate-risk devices, like blood pressure monitors and infusion pumps.
- Class C: High-risk devices that require stringent controls, including cardiac stents and ventilators.
- Class D: Devices with the highest risk, such as implantable pacemakers and deep brain stimulators.
The manufacturer of medical devices, authorized agent or authorized representative, and importers can submit the form for the registration of CDSCO.
The registration times for different types of medical device licenses in India are as follows:
MD-5 Medical Device License (Class A and B Devices): Typically takes around 3 to 6 months. This license is required for the manufacturing of Class A and B devices, which are considered lower to moderate risk.
MD-9 Medical Device License (Class C and D Devices): Generally requires 9 to 12 months. This license covers the manufacturing of Class C and D devices, which are higher risk and subject to more rigorous scrutiny.
MD-15 Medical Device Import License: Usually takes about 6 to 9 months. This license is needed for the importation and distribution of medical devices in India.
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+91 9891232884
info@cdscoregistration.com
Get expert support for CDSCO medical device registration. Contact us for a free consultation call today!
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+91 9891232884
info@cdscoregistration.com
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