How To Register Medical Devices in India?
Central Drug Standard Control Organization (CDSCO) has released the Medical Devices amendment rule and classification of non-notified medical device and In-vitro diagnostics (IVD’s) and according to that devices have been classified into 24 categories of medical devices and 3 Categories of In-Vitro Diagnostics.
According to CDSCO, The registration is on voluntary basis for a period of eighteen months, from the commencement of this rule, after which it will be compulsory after the end of voluntary registration period, it shall be mandatory to obtain the registration number and it would be done in phases.
We at MEDBOTICS offers a skilled guidance for acquiring import license and manufacturing licenses for the medical devices in India. please be aware that separate licenses are required to be obtained for the manufacture and import of medical devices as separate conditions are enforced to be fulfilled for obtaining these licenses.
There are various classes of devices such as:
Class A- Low Risk
Class B- Low to ModerateRisk
Class C- Moderate to High Risk
Class D- High Risk
What We Offer
- We guide you to identify the category according to the new classifications of the medical devices based on the intended purpose.
- We guide the process to obtain the import license and or manufacturing licence and support to obtaining permission to conduct clinical trials as required and also suggest best CRO’s to choose.
- Medical Device Registration in India under CDSCO requires lots of documentation and fresh applicants may find it difficult to comply with such requirements, in such a case, we guide you on each step of the licensing procedure and simplify the process.
