To grant registration certificates, the state authorities have been requested to nominate licensing authorities to difficulty the registration certificates for the medical system vendor. The registration certificates shall be required to promote, inventory, exhibit, supply on the market or distribute a medical system together with in vitro diagnostic medical units,
The software for on-line registration must be accompanied by a price prescribed within the second schedule, self–certificates of compliance, particulars of the applicant with ID proof, documentary proof of possession/rental occupancy of premises getting used, particulars of competent technical workers monitoring gross sales exercise of the medical units, description on different actions being carried inside the mentioned premises and endeavor that the applicant fulfills the storage necessities to deal with medical units.
Reacting to the amendments made to medical units guidelines, Rajiv Nath, Forum Coordinator, AiMeD mentioned, “Thankfully, this enforces reasonable and minimal requirement of registration by a reseller of medical devices and is in line with our recommendations to CDSCO & MOH&FW. It’s a good intent to register and for the regulators to know the vast landscape before attempting to regulate it as medical devices are sold in malls by non-chemists eg spectacles, wheelchairs, personal weighing machines, adult diapers, oximeters etc. All these are medical devices under Medical Devices regulations, Our further request though is to have a separate medical devices law that will decriminalise most minor offenses as medical devices are not drugs.”