By way of a notification dated March 16, 2018, the Central Drugs Standard Control Organization,(“CDSCO”) has issued a comprehensive set of ‘Frequently Asked Questions’ (“FAQs”), along with the answers, for better understanding of the Medical Device Rules 2017 (“Rules”). This information come beside the FAQs earlier issued by CDSCO.
Key Highlights:
- What will be the status of the application for grant of licence which are applied before 01.01.2018 but are still in process and not granted the licence?
The application for grant of licence which are applied before 01.01.2018 but are still in process and not granted the licence, the applicant will need to pay balance fees and also reapply on the online portal as per the Current Medical Device Rules 2017.
- What will be the status of application for additional products on old existing licence in similar category, made after 01.01.2018 which are not yet issued?
For inclusion of additional products on existing licence as per practices followed, additional fees and documents will have to be submitted as per current Medical Device Rules 2017.
- iii. What will be applicability !utility of old SUGAM for applicants, with respect to existing Registration Certificate import Licenses?
Old SUGAM will remain operative for additional product endorsement, post approval changes of existing Registration Certificate and Import licenses (as on 1.1.2018) till their expiry or till 30.07.2017, whichever is later as per Medical Devices Rules, 2017.
- What will be the status of competent person existing on the licence before 01.01.2018 for manufacturing and testing?
As per the saving clause of Rule 97 prescribed in Medical Devices Rules, 2017 those competent persons will continue to remain so. For details the stake holders may also refer to Medical devices and Diagnostics section in the CDSCO website.
Kindly refer to the hyperlinked source below for all FAQs and their answers.
Source: Ministry of Health and Family Welfare
