DCGI To Recommend DTAB To Exempt Drug Sale License For Import Of High Tech Equipment

PSM News /

Mumbai, 13 Nov 2019:

 

The Drugs Controller General of India (DCGI) is planning to recommend Drug Technical Advisory Board (DTAB) to exempt drug sale license for import of high tech equipment like X-Ray, MRI, PET, Ultrasound and CT Scan based on stakeholders suggestions.

 

It was brought to the notice of DCGI office during the meeting of stakeholders of Medical Devices held on October 15, 2019 that an exemption from drugs sale license (20B & 21B) for the import of high tech equipment like X-Ray, MRI, PET, Ultrasound and CT Scan under medical device rules (MDR)-2017 is required.

 

As per the DCGI notice, importers of such equipment need to maintain all records of transactions, installations, maintenance and agreements. Accordingly, a proposal will be officially moved to DTAB for exemption from drugs sale license for such equipment under MDR-2017. All stakeholders are requested to forward their comments at ddcimd-cdsco@nic.in.

 

The Central Drugs Standard Control Organisation (CDSCO) had recently issued guidelines on performance evaluation of In-Vitro Diagnostic (IVD) medical devices for grant of manufacturing and import licenses as per new Medical Device (MD) Rules, 2017 which is effective from January 1, 2018.

 

It has also issued reference list of laboratories in the country for conducting performance evaluation of IVDs. It has directed the notified laboratories to test and evaluate IVD medical devices and issue performance evaluation reports (PERs) for the purpose of grant of manufacturing and import licenses.

 

Import license is issued by CDSCO in India for an individual or industry having wholesale or manufacturing license for medical devices.

 

PERs have to be done on three batches of IVD tests with support from notified labs as per the new MD Rules, 2017.

 

PERs mandated for IVD tests include HIV, HBV, HCV, blood grouping reagent, cancer, tuberculosis, malaria, dengue, chikunguia, syphlis, typhoid, infuenza, toxoplasma gondii, rubella virus, cytomegalovirus, herpes simplex virus (ToRCH), chlamydia, pneumonia, methioilllne resistant staphylococcus aureus (MRSA), entero virus, marker for congenital disorder for example screen test for Down's syndrome, sexually transmitted agent i.e. Treponema pallidum, neisseria gonorrhoeae, human papillomavirus (HPV), herpes virus and other life threatening infections or agent. Pharmabiz