Dear colleagues,

Here is my usual selection of highlights in medical device regulatory updates in Russia over the past month:

1. Implementation of new post-market control measures for medical devices in Russia

On 30 July 2021 the Russian government released Resolution 1066 (link in Russian) and implemented new regulations which significantly changed control measures for organizations involved in the turnover of medical devices in Russia (including manufacturers, distributors and customers [medical centres]).

The document implemented changes in the forms and schedules of the control inspections performed by the regulator. The scheduled inspections will be carried out every 4 to 6 years, depending on the risk classification of the organization, and will not be needed for organizations in low risk groups.

In addition to planned inspections, the document introduced additional control measures such as inspection visits, test purchases and random sample checks of medical devices.

2. Update on quality management system requirements for medical device manufacturers

In July 2021 the Russian government released two draft guidelines on the quality management system (QMS) requirements for medical device manufacturers.

The draft regulation “on requirements for the implementation, maintenance and evaluation of the quality management system of medical devices depending on their risk classification” (link in Russian) provides a description of the scope of the QMS assessment including design and development, processes for managing documents and records, final inspection processes, corrective and preventive action, and customer-related processes.

The document refers to Russian standard GOST ISO 13485-2017 and Eurasian Decision #106 as guidelines for implementation of the QMS.

Another document published in July 2021 is a draft regulation on conducting QMS inspections of medical device manufacturers (link in Russian).

The published guidance provides differentiation between three types of QMS audits:
1. Initial QMS inspections that must be performed for all manufacturing sites mentioned for registration application.
2. Scheduled regular QMS inspections that must be performed every 5 years for manufacturing sites selected by the regulator.
3. Unplanned QMS inspections that must be performed in certain cases of registration amendments or after completion of corrective actions.

The draft document provides a matrix for the assessment of the significance of the observations recorded during an inspection, which, according to the rules, must be closed within 30 days of the audit.

The document also provides guidance on calculating the duration of an audit, which may vary from 6 to 13 days depending on the headcount of the manufacturing organization. However, the entire inspection process may not exceed 90 days from the submission of the application.

There are several cases for which the regulations allow performing a QMS audit remotely, conditional upon performing an on-site audit within 2 years

3. New regulatory requirements for certain in-home in-vitro diagnostics

On 15 July 2021 the Russian Ministry of Health published a draft regulation (link in Russian) describing new potential approval routes for, as well as regulatory requirements of, certain in-vitro diagnostic (IVD) products (i.e. ‘in-house/home-brew’ IVD assays) developed and manufactured by individual laboratories.

According to the draft regulations such products may undergo an accelerated approval process via the obtainment of a special 5-year permit for clinical/diagnostic use in particular laboratories without registration. The document provides a detailed description of the approval procedure and requirements for submission of an application package.

The procedure is expected to be applicable for IVD products without registered analogue in Russia both made and intended for use by a specific laboratory or organization and will consider an assessment of the financial cost of registration and any existing need for diagnostics using the product.