Roszdravnadzor will test new forms of state control over the medical device market

The Ministry of Health of the Russian Federation presented an updated draft Regulation on state control over the market of medical devices. The new edition will increase the intervals of checks – they will be carried out once every 4-10 years for participants in the medical device market classified as moderate, medium and significant risk. New forms of control will appear – a preventive and inspection visit, as well as control and monitoring purchases, which will be carried out by Roszdravnadzor. It is assumed that the regulation will enter into force on July 1, 2021 and will be valid for six years.
The department has retained the basic principles of a risk-based approach to monitoring the market of medical devices: depending on the risk class, types, addresses of production and use, storage, transportation, clinical trials of medical devices, as well as the profile of the audited organization, a score rating will be formed, according to which market participants will be divided into four categories – low, moderate, medium and significant risk.

The first category, as in the previous edition of the regulation, will be exempted from scheduled inspections, and the intervals for the rest will be increased: for significant risk – from 3 to 4 years, medium – from 4 to 6 years, moderate – from 6 to 10 years. The criteria, as well as the points system, will remain in the version of the Government Decree No. 970 of September 25, 2012.

Roszdravnadzor will introduce new forms of preventive work – informing, summarizing law enforcement practice, consulting, announcing a warning and a preventive visit, which the audited legal entity can refuse by notifying the regulator at least three working days before the visit.

The forms of control will also be expanded – the list of methods will include documentary and field inspections, selective quality control, control and monitoring purchases, observation of compliance with mandatory requirements (safety monitoring) and an inspection visit.

In the course of a documentary audit, the regulator will have the right to request documents, receive explanations and conduct an examination, on-site inspection – to conduct an inspection, a survey, receive written explanations, select documents, samples, as well as tests and expertise.

With a test purchase, the number of Roszdravnadzor methods will additionally include an experiment, with a monitoring purchase – instrumental examination.

The indicators of control over the market of medical devices will be determined according to two criteria – the shares of decisions, orders made based on the results of control measures and consideration of complaints for the reporting year and the previous year, which were canceled partially or completely on the basis of judicial acts that entered into force in the reporting year. The number of such acts will be divided by the total number of orders issued.

If approved, the amendments will enter into force on July 1, 2021 and will be valid until July 1, 2027.

At the end of December 2018, Russian President Vladimir Putin signed a law giving Roszdravnadzor the right to conduct test purchases. The department planned to use the new powers to combat the sale of substandard drugs and identify violations in the provision of medical services. It was assumed that the test purchases of medical devices would be carried out „in order to verify compliance with the ban on the sale of counterfeit medical products, substandard medical products and counterfeit medical products.“

According to the results of state control for 2020, Roszdravnadzor in the course of 1,183 inspections revealed 223 substandard and 168 unregistered medical devices. Almost 300 items of medical devices were withdrawn by the manufacturer, 51 more were withdrawn from circulation by the regulator. 769 reports on administrative offenses were drawn up against the participants of the medical device market, of which 187 – under Art. 6.28 of the Code of Administrative Offenses of the Russian Federation (violation of established rules in the field of circulation of medical products), and three – under Art. 6.33 of the Administrative Code (circulation of substandard, falsified, counterfeit or unregistered medical products). The total amount of fines imposed was 6.459 million rubles.