What is the regulatory environment for medical devices in India as per 'New Medical Devices Rules'?
The Ministry of Health and Family Welfare published the 2017 Medical Devices Regulations, which are in line with the framework of the Global Harmonization Task Force (GHTF). The rules are valid as of 1 January 2018. The rules were drawn up with the purpose of separating medical devices from pharmaceuticals for enhanced and well-defined supervision. The following are the main highlights of the rules:
What is the regulatory environment for medical devices in India as per 'New Medical Devices Rules'?
The Ministry of Health and Family Welfare published the 2017 Medical Devices Regulations, which are in line with the framework of the Global Harmonization Task Force (GHTF). The rules are valid as of 1 January 2018. The rules were drawn up with the purpose of separating medical devices from pharmaceuticals for enhanced and well-defined supervision. The following are the main highlights of the rules:
1) The redefinition of 'medical equipment' makes it easier to understand and more detailed.
2) Introduction of a method of risk-based classification for class-wise control.
3) Single window clearance (online portal) for import, processing, sale or distribution and clinical investigation applications.
4) Creation of product specifications for compliance with medical devices.
5) Rationalization of the timelines for obtaining the requisite license for the selling of medical devices.
6) The incorporation into a single license of the registration certificate and the import license.
7) A new regulatory structure for medical devices clinical investigations.
What are the requirements to be a registered Notified body?
The requirements are laid down in Part I of the Third Schedule of Medical Devices Rules, 2017.
What is the process for classification verification with CDSCO or notified body prior to submission?
The Central Licensing Authority shall, on the basis of its intended usage and other criteria stated in the First Schedule, identify the medical devices referred to in Rule 2. The Class Wise List of Medical Devices shall be published on the website of the Central Standard Drug Control Organization (CDSCO) on the basis of the classification referred to in sub-rule (3): provided that the Central Licensing Authority may, from time to time, add to or remove such a list of medical devices or change the class of any medical device. The list of classified medical devices has already been displayed by CDSCO, and is complex in nature.
What are the changes that require an applicant to make a fresh Registration?
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