Mar 31, 2017
EMERGO SUMMARY OF KEY POINTS:
The Russian Ministry of Health has issued a new regulation to explain longstanding but unofficial technical file and instructions for use requirements for medical device and IVD registrants.
The new regulation, Order #11N (link in Russian), mostly clarifies existing requirements from Russian medical device regulator Roszdravnadzor; however, the regulator has never officially published these requirements until now, according to Emergo sources in Moscow.
Again, Roszdravnadzor registrants should already be familiar with most of Order #11N’s contents, but the official order should help reduce any confusion and ambiguity regarding proper compliance.
Among technical file requirements previously not explicitly noted by Russian regulators are:
In addition, Order #11N does include some minor new requirements of which medical device and IVD manufacturers should be aware:
Russian medical device and IVD market registrants had already been providing most of this technical information before issuance of the new order, so Roszdravnadzor’s latest move should not cause any drastic changes for technical file compliance.
EMERGO SUMMARY OF KEY POINTS:
Governments of five Eurasian countries have issued final regulations to establish a harmonized regulatory system for medical devices and IVDs across their respective jurisdictions.
EMERGO SUMMARY OF KEY POINTS: