Last Updated on December 7, 2020 by The Health Master
The Union health ministry will soon amend Medical Device Rules (MDR)-2017 to include the provision for allowing the import of medical devices having lesser shelf-life period but before the date of expiry in exceptional cases based on industry representations.
Representations were received from the associations with the request to provide relaxation of residual shelf life requirements for medical devices and IVDs citing the reason that medical device industry is facing challenges in getting dispatches from overseas manufacturing sites, getting international cargo transportation and clearing the imported devices at port offices due to C-19 pandemic across the globe.
In the due course, the medical devices/In-vitro Diagnostics (IVD) are losing the shelf life and getting below the threshold limits of residual shelf-life.
Drugs Technical Advisory Board (DTAB) was apprised of the matter that, as per the provision of Rule 47 of MDR- 2017, the requirement of residual shelf-life on the date of import is as follows: any medical device, whose total shelf life claim is less than 90 days, shall not be allowed to be imported if it has less than 40% residual shelf-life on the date of import; any medical device, whose total shelf life claim is between 90 days and one year, shall not be allowed to be imported if it has less than 50% residual shelf-life on the date of import; any medical device, whose total shelf life claim is more than one year, shall not be allowed to be if it has less than 60% residual shelf-life on the date of import.
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In view of the concerns highlighted by the associations, considering the short shelf life of IVD and logistic issues faced by the industry in the supply of medical device and IVD kits/reagents, it was proposed that Rule 47 of Medical Device Rule, 2017 may be amended to include the following provisions.
In the Medical Devices Rules, 2017, in Rule 47, after the third provision, the following proviso shall be inserted namely,- “Provided also that in exceptional cases the Central Licensing Authority may, for reasons to be recorded in writing, may allow, the import of any medical device having lesser Shelf-life period, but before the date of expiry as declared on the container of the medical device”.
DTAB deliberated the proposal and recommended for the amendment of the MDR-2017 to include the provision for allowing the import of medical devices having lesser shelf-life period but before the date of expiry in exceptional cases.
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