Medical Device Registration in Noida
How to get the Medical Device Registration in Noida?
India’s medical device market is expected to grow over the next several years due to increased health awareness, a growing middle class, and government health initiatives. Indian authorities overhauled the medical device regulatory process in 2017 with the publication of the Medical Device Rules. The rules came into force in January 2018 and devices are regulated by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare.
Medical device registration requirements
Manufacturers interested in registering their medical devices in India must supply proof of approval in their home market. The medical device registration in Noida needs some special requirement. Providing further evidence of prior regulatory authorization in the US, Canada, Europe, Australia, or Japan can ease some regulatory requirements. So, Your technical documentation must be submit for review by the CDSCO. In addition, you must register all of your device manufacturing facilities.
Functionalities of medical registration
- Grant of Certificate of Registration for a Notified Body for audit of Class A and Class B Medical Devices. A notified body accredited by National Accreditation Body (designated by Central Government) may apply in MD 1 to CLA for grant of registration certificate in MD 2.
- Grant of Import Licence: The applicant shall make an application in MD-14 in Sugam online portal for grant of import licence in MD-15 to import Medical Devices.
- Grant of licence or loan license to manufacture for sale or for distribution. The applicant shall make an application in MD-7 & MD-8 in Sugam online portal for Grant of manufacturing Licence / Loan License to Manufacture for Sale or for Distribution of Class C or Class D in MD-9 & MD-10.
- Grant of test licence to manufacture for test, evaluation, clinical investigations, etc.: The applicant shall make an application in MD-12 in SUGAM online portal for licence in MD-13 to manufacture Medical Devices for purpose of clinical investigations, test, evaluation, examination, demonstration or training.
What is the different regulatory classification for medical devices?
Currently there is not a formal regulatory classification scheme, however, draft regulations outline the following:
- Class A – Low Risk (example: thermometers, tongue depressors)
- Class B – Low-moderate Risk (example: hypodermic needles, suction equipment)
- Class C – Moderate-high risk (example: lung ventilator, bone fixation)
- Class D – High Risk (example: heart valves, implantable devices)
License Holder Requirements
The License Holding Agent is granted Power-of-Authority, listed on local labeling, and handles customs clearance, and post-market vigilance. Post-market vigilance entails notifying the CDSCO as well as Materio vigilance Program of India (MvPi) of Serious Adverse Events (SAE) occurring in India.
MEDICAL DEVICES REGULATORY SERVICES
Medical Devices have always been an object of concern and regulation by the Indian Government. Thus, with advancing medical technology and the exponentially rising need of medical devices in the country. New reforms as well as rules have come into effect. Medical devices have been categorized into A, B, C and D classes and are govern by respective central and state regulatory authorities. So, regulatory bodies classify medical devices based upon the associated risk and have defined relatively easy procedures for license applications. Similarly, rules and guidelines have been promulgated by the government for the import of medical devices. Whereby, all one needs is to have an authorized Indian agent to apply for the license. The medical device registration in Noida is too easy.
With the reformative intervention and efforts of the government such as the SUGAM portal, obtaining medical device licenses is now an expedite procedure.
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