Medical devices have come a long way due to advancement in technology and are being used in each and every aspect of medical treatment. The Central Drugs Standard Control Organization (CDSCO) plays an important role in safeguarding and enhancing public health by ensuring the quality, safety and efficacy of drugs, cosmetics and medical devices. It is the Central Drug Authority in India for fulfilling functions allocated to the Central Government under the Drugs and Cosmetics Act.
Our highly skilled and trained team at CliniExperts provides a stress-free approach to obtain your manufacturing or import license and registration for medical devices. This way you can focus on important aspects such as manufacturing the medical device and let us worry about the tedious licensing and registration procedures.
Medical devices are classified under notified and non-notified medical devices. Notified medical devices require complete registration while non-notified medical devices only require a clarification letter for import or manufacturing. However, both do require a manufacturing license, if being manufactured here in India. Furthermore, registration is not required for import of non-notified medical devices in India. However, certain devices that are regulated as drugs under the Drugs and Cosmetics Act and Rules require registration and import license to India such as:
There are stringent and lengthy rules and regulations put in place to guarantee appropriate manufacturing of medical devices. The most recent clarification was post in 2014 by the CDSCO in response to several requests for clarification of unclear guidelines. In 2014, the CDSCO posted additional clarification information regarding the control of various medical devices. The one before that was in 2012.
Clarification as regards the regulatory status of any medical device to be registered in India is as follows: