Get expert assistance for CDSCO Medical Device Registration, Manufacturing License, Import License, device classification, documentation, and regulatory compliance under Medical Device Rules, 2017. UMSPCS provides end-to-end consultancy across India.
CDSCO Certification for Medical Device
- BIS Registration Guidance
- Application Filing Support
- BIS Authority Coordination
- Cost & Timeline Clarity
- Complete Documentation Help
CDSCO Certificate for Medical Devices and Equipments
In order to launch your devices in the Indian market, it becomes important to comply with the regulations laid down by the Central Drugs Standard Control Organisation (CDSCO). Be it an Indian Manufacturer, Importer or even Foreign Manufacturer, it is mandatory to have a CDSCO Certificate for Medical Devices before you manufacture, import, distribute or sell any products in the country.
UMSPCS provides you with assistance for the entire process of getting a CDSCO Certificate for Medical Devices in an easy and effective manner. With 6+ Years of Industry Experience and 600+ successful product compliance projects, we guide you in classification of the product, documentation, filing applications, coordination of regulations, among others.
- CDSCO Certification for Medical Devices
- Classification of Medical Devices
- Eligibility for Regulation
- Documentation Preparation & Verification
- Filing of Online Applications using CDSCO SUGAM Portal
- Assistance in Obtaining Import Licenses and Manufacturing Licenses
- Assistance in Appointing an Authorized Indian Agent for Foreign Manufacturers
- CDSCO Queries and Compliance Services
- Compliance after Approval
- License Renewal and Amending Services
Our regulatory experts will take care of all the above steps in obtaining a certificate for your medical device according to CDSCO regulations.
Frequently Asked Questions (FAQs)
The CDSCO Certificate is a regulatory approval needed for medical devices subject to the Medical Devices Rules, 2017 prior to manufacturing, importing and marketing the products in India.
Yes, CDSCO certification is compulsory for notified medical devices as per Medical Devices Rules, 2017. The rules differ from one another depending on the medical device class and its purpose.
Indian manufacturers, foreign manufacturers through Authorized Indian Agent, importer or authorised representative can apply for a CDSCO certificate.
Required documentations for CDSCO certificate include product specification, technical documentations, quality management certificate, manufacturing information, Free Sale Certificate (in case of import), authorisation letter, and other regulatory
Generally speaking, medical devices can be classified as either Class A, B, C, and D according to the risks associated with the medical devices. In such a case, class A and D medical devices represent low and high risks of medical devices.
It totally depends on the classification of the device, quality of the application, technical review, and the CDSCO process. Correct documentation is important to speed up the process.
Yes, the CDSCO approval can be obtained by the foreign manufacturers by appointing the Authorised Indian Agent.
