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The MD-42 Certificate does not have a fixed expiry period like a certificate that needs to be renewed every year. Under the Medical Devices Rules, 2017, an MD-42 registration certificate issued by the State Licensing Authority remains valid in perpetuity, provided the applicable retention fee is paid within the prescribed time.
The retention fee has to be paid once every five years from the date of issue of the MD-42 Certificate. This means the certificate itself does not expire after five years, but the holder must complete the required retention-fee payment to keep the registration active.
It is also important to maintain compliance with the applicable requirements for selling, stocking, exhibiting, or distributing medical devices. The State Licensing Authority can suspend or cancel the registration in cases of non-compliance.
Therefore, businesses should keep track of the five-year retention-fee deadline and maintain the required records and conditions associated with their MD-42 registration.
Before relying on older information, applicants should check the latest Medical Devices Rules and CDSCO guidance because regulatory requirements can be amended from time to time.
The retention fee has to be paid once every five years from the date of issue of the MD-42 Certificate. This means the certificate itself does not expire after five years, but the holder must complete the required retention-fee payment to keep the registration active.
It is also important to maintain compliance with the applicable requirements for selling, stocking, exhibiting, or distributing medical devices. The State Licensing Authority can suspend or cancel the registration in cases of non-compliance.
Therefore, businesses should keep track of the five-year retention-fee deadline and maintain the required records and conditions associated with their MD-42 registration.
Before relying on older information, applicants should check the latest Medical Devices Rules and CDSCO guidance because regulatory requirements can be amended from time to time.