P
PFD2010
Good Afternoon All,
I have a query regarding some new draft legislation regarding the Russian Agency GOST-R that I hope someone can help with?
I have been informed that there is a new upcoming legislation relating to the law titled "On approval of Administrative Regulations on Federal Service on Surveillance in Healthcare and Social Development executing the state function of medical-purpose devices registration". Reading the draft text (of 1 line in section 2.1.1) which means that product re-registration with GOST-R is required in cases where the specifications and instruction in the IFU change (which is understanable) or if the details of the Legal Manufacturer change e.g. address change. The new legislation indicates that manufacturers need to re-register all products with GOST if the legal manufacturer address changes as the existing certificates note the complete name and full address.
Does anyone have an alternative view on this, or know of further specifics regarding the changes to the law? If changes are made to the Legal Manufacturer address, is immediate re-registration required or can a simple notification be sent to GOST detailing the change?
Please let me know if I have grasped the wrong end of the stick here.
Thanking you in advance,
Paul
I have a query regarding some new draft legislation regarding the Russian Agency GOST-R that I hope someone can help with?
I have been informed that there is a new upcoming legislation relating to the law titled "On approval of Administrative Regulations on Federal Service on Surveillance in Healthcare and Social Development executing the state function of medical-purpose devices registration". Reading the draft text (of 1 line in section 2.1.1) which means that product re-registration with GOST-R is required in cases where the specifications and instruction in the IFU change (which is understanable) or if the details of the Legal Manufacturer change e.g. address change. The new legislation indicates that manufacturers need to re-register all products with GOST if the legal manufacturer address changes as the existing certificates note the complete name and full address.
Does anyone have an alternative view on this, or know of further specifics regarding the changes to the law? If changes are made to the Legal Manufacturer address, is immediate re-registration required or can a simple notification be sent to GOST detailing the change?
Please let me know if I have grasped the wrong end of the stick here.
Thanking you in advance,
Paul