Russia medical device regulations

For clause 111 non-expertise changes, clause 112 requires submission through the unified applicant cabinet no later than90 working days after the relevant data changed. Clause 120 provides the same filing deadline for clause 119 expertise changes.

Clause 113 limits the non-expertise dossier-change procedure to 18 working days from receipt of the application and the documents required by clause 112. Clause 114 provides a five-working-day completeness/accuracy check; clause 117 provides a three-working-day start decision after the check or rectification; and clause 118 provides a ten-working-day decision/register-update phase after the start decision. Under clause 115, the interval from deficiency notification until receipt of the response or notice that no response was provided is excluded from the procedure time.

Clause 112 requires the change application and describes supporting evidence including authorized-representative powers and confirmation that changes do not impair device safety/quality/efficacy or change intended purpose/principle of operation. Additional QMS documents are conditional on the specified low-risk/QMS route. Expertise-route documents are specified separately in clause 120.

For clause 111 non-expertise changes, clause 112 requires submission through the unified applicant cabinet no later than90 working days after the relevant data changed. Clause 120 provides the same filing deadline for clause 119 expertise changes.

Clause 113 limits the non-expertise dossier-change procedure to 18 working days from receipt of the application and the documents required by clause 112. Clause 114 provides a five-working-day completeness/accuracy check; clause 117 provides a three-working-day start decision after the check or rectification; and clause 118 provides a ten-working-day decision/register-update phase after the start decision. Under clause 115, the interval from deficiency notification until receipt of the response or notice that no response was provided is excluded from the procedure time.

Clause 112 requires the change application and describes supporting evidence including authorized-representative powers and confirmation that changes do not impair device safety/quality/efficacy or change intended purpose/principle of operation. Additional QMS documents are conditional on the specified low-risk/QMS route. Expertise-route documents are specified separately in clause 120.

For clause 111 non-expertise changes, clause 112 requires submission through the unified applicant cabinet no later than90 working days after the relevant data changed. Clause 120 provides the same filing deadline for clause 119 expertise changes.

Clause 113 limits the non-expertise dossier-change procedure to 18 working days from receipt of the application and the documents required by clause 112. Clause 114 provides a five-working-day completeness/accuracy check; clause 117 provides a three-working-day start decision after the check or rectification; and clause 118 provides a ten-working-day decision/register-update phase after the start decision. Under clause 115, the interval from deficiency notification until receipt of the response or notice that no response was provided is excluded from the procedure time.

Clause 112 requires the change application and describes supporting evidence including authorized-representative powers and confirmation that changes do not impair device safety/quality/efficacy or change intended purpose/principle of operation. Additional QMS documents are conditional on the specified low-risk/QMS route. Expertise-route documents are specified separately in clause 120.

Clause 111(е) includes removing information about a medical-device model (make) from the register entry among dossier changes not requiring quality, efficacy and safety expertise.

For clause 111 non-expertise changes, clause 112 requires submission through the unified applicant cabinet no later than90 working days after the relevant data changed. Clause 120 provides the same filing deadline for clause 119 expertise changes.

Clause 113 limits the non-expertise dossier-change procedure to 18 working days from receipt of the application and the documents required by clause 112. Clause 114 provides a five-working-day completeness/accuracy check; clause 117 provides a three-working-day start decision after the check or rectification; and clause 118 provides a ten-working-day decision/register-update phase after the start decision. Under clause 115, the interval from deficiency notification until receipt of the response or notice that no response was provided is excluded from the procedure time.

Clause 112 requires the change application and describes supporting evidence including authorized-representative powers and confirmation that changes do not impair device safety/quality/efficacy or change intended purpose/principle of operation. Additional QMS documents are conditional on the specified low-risk/QMS route. Expertise-route documents are specified separately in clause 120.

Clause 110 requires registration of a new medical device for a change to its intended purpose or principle of operation; inclusion of model/make information that does not satisfy the grouping criteria in clause 26; or simultaneous changes to manufacturer and manufacturing-site information, subject to the express exceptions for legal form, address of location, reorganization and other constituent-document information.

For clause 111 non-expertise changes, clause 112 requires submission through the unified applicant cabinet no later than90 working days after the relevant data changed. Clause 120 provides the same filing deadline for clause 119 expertise changes.

Clause 113 limits the non-expertise dossier-change procedure to 18 working days from receipt of the application and the documents required by clause 112. Clause 114 provides a five-working-day completeness/accuracy check; clause 117 provides a three-working-day start decision after the check or rectification; and clause 118 provides a ten-working-day decision/register-update phase after the start decision. Under clause 115, the interval from deficiency notification until receipt of the response or notice that no response was provided is excluded from the procedure time.

Clause 112 requires the change application and describes supporting evidence including authorized-representative powers and confirmation that changes do not impair device safety/quality/efficacy or change intended purpose/principle of operation. Additional QMS documents are conditional on the specified low-risk/QMS route. Expertise-route documents are specified separately in clause 120.

For clause 111 non-expertise changes, clause 112 requires submission through the unified applicant cabinet no later than90 working days after the relevant data changed. Clause 120 provides the same filing deadline for clause 119 expertise changes.

Clause 113 limits the non-expertise dossier-change procedure to 18 working days from receipt of the application and the documents required by clause 112. Clause 114 provides a five-working-day completeness/accuracy check; clause 117 provides a three-working-day start decision after the check or rectification; and clause 118 provides a ten-working-day decision/register-update phase after the start decision. Under clause 115, the interval from deficiency notification until receipt of the response or notice that no response was provided is excluded from the procedure time.

Clause 112 requires the change application and describes supporting evidence including authorized-representative powers and confirmation that changes do not impair device safety/quality/efficacy or change intended purpose/principle of operation. Additional QMS documents are conditional on the specified low-risk/QMS route. Expertise-route documents are specified separately in clause 120.