hemshru123
Registered
Hi,
Can anyone help me on the registration process / new requirements for Georgia country.
We are class III manufacturer i.e. Drug Eluting Coronary Stent System & PTCA Balloon Catheter from India. Our distributor communicated that "According Georgian MOH new regulation product must be certified from FDA, or MDR, or CE. In case CE still is mandatory then manufacturers products will be mentioned in EU Cardiology Association Guideline (ESC). in case of CE, it is allowed to implant DES if manufacturers any stent is mentioned in ESC guideline, any suggestion on compliance for ESC guideline for Stent product. We have our own product clinical trail data from Europe it self.
Our products are MDD CE certified and MDR transition is In-process, but as per our distributor our stent product must be mentioned in ESC guideline.
Can anyone help me on the registration process / new requirements for Georgia country.
We are class III manufacturer i.e. Drug Eluting Coronary Stent System & PTCA Balloon Catheter from India. Our distributor communicated that "According Georgian MOH new regulation product must be certified from FDA, or MDR, or CE. In case CE still is mandatory then manufacturers products will be mentioned in EU Cardiology Association Guideline (ESC). in case of CE, it is allowed to implant DES if manufacturers any stent is mentioned in ESC guideline, any suggestion on compliance for ESC guideline for Stent product. We have our own product clinical trail data from Europe it self.
Our products are MDD CE certified and MDR transition is In-process, but as per our distributor our stent product must be mentioned in ESC guideline.
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