{"id":2485,"date":"2026-10-20T11:36:55","date_gmt":"2026-10-20T08:36:55","guid":{"rendered":"https:\/\/grandlocus.com\/?post_type=resources&p=2485"},"modified":"2026-10-20T11:36:55","modified_gmt":"2026-10-20T08:36:55","slug":"order-%e2%84%964513","status":"publish","type":"resources","link":"https:\/\/grandlocus.com\/en\/resources\/order-%e2%84%964513\/","title":{"rendered":"Order \u21164513"},"content":{"rendered":"

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
\n<\/strong>FEDERAL SERVICE FOR SURVEILLANCE IN HEALTHCARE
\n<\/strong>ORDER<\/strong><\/p>\n

 <\/p>\n

dated 20 May 2021 N 4513<\/strong><\/p>\n

 <\/p>\n

ON APPROVAL OF THE CLASSIFICATION
\n<\/strong>OF ADVERSE EVENTS RELATED TO THE CIRCULATION
\n<\/strong>OF MEDICAL DEVICES<\/strong><\/p>\n

 <\/p>\n

In accordance with part 1 of Article 96<\/a> of Federal Law dated 21.11.2011 N 323-FL “On the Fundamentals of Health Protection of Citizens in the Russian Federation” (Collection of Legislation of the Russian Federation, 2011, N 48, Art. 6724; Official Internet Portal of Legal Information http:\/\/pravo.gov.ru. 30.04.2021), I hereby order:<\/p>\n

To approve the attached classification<\/a> of adverse events related to the circulation of medical devices.<\/p>\n

 <\/p>\n

Head
\n<\/em>A.V.SAMOYLOVA<\/em><\/p>\n

 <\/p>\n

Appendix
\n<\/em>to the Order of Roszdravnadzor
\n<\/em>dated 20.05.2021 N 4513
\n<\/em>CLASSIFICATION
\n<\/em>OF ADVERSE EVENTS RELATED TO THE CIRCULATION
\n<\/em>OF MEDICAL DEVICES<\/em><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Adverse events<\/td>\nCode<\/td>\n<\/tr>\n
Incompatibility of the intended purpose and performance characteristics of the medical device recommended by the manufacturer with the age, sex, weight, height or other parameters of the patient<\/td>\n\u041001<\/td>\n<\/tr>\n
Deviation from the design parameters of the medical device occurring during production, manufacture, packaging or delivery<\/td>\n\u041002<\/td>\n<\/tr>\n
Deviation from the design parameters of the medical device, (chemical characteristics), occurring during production, packaging or delivery<\/td>\n\u041003<\/td>\n<\/tr>\n
Deviation from the design parameters of the medical device concerning the reliability of the materials used in its production<\/td>\n\u041004<\/td>\n<\/tr>\n
Unforeseen mechanical effect of the medical device on the patient<\/td>\n\u041005<\/td>\n<\/tr>\n
Unsatisfactory quality of the transmitted image affecting the operation of the medical device<\/td>\n\u041006<\/td>\n<\/tr>\n
Malfunction of the electrical circuit of the medical device<\/td>\n\u041007<\/td>\n<\/tr>\n
Disruption of the calibration of the medical device affecting its accuracy<\/td>\n\u041008<\/td>\n<\/tr>\n
Deviation from the technical documentation of the medical device affecting the data transmitted by the medical device<\/td>\n\u041009<\/td>\n<\/tr>\n
Deviation from the operating temperature regime of the medical device leading to its overheating or overcooling<\/td>\n\u041010<\/td>\n<\/tr>\n
Negative effect of program code or software on the operation of the medical device<\/td>\n\u041011<\/td>\n<\/tr>\n
Incorrect connection of the medical device or its functional units to systems for the supply of liquids, gases, electricity or for data transmission<\/td>\n\u041012<\/td>\n<\/tr>\n
Failures in sending or receiving signals, or data between internal components of the medical device<\/td>\n\u041013<\/td>\n<\/tr>\n
Defects in the circulation of liquid or gases in the medical device (including the vacuum generation process)<\/td>\n\u041014<\/td>\n<\/tr>\n
Deviation from the design parameters of the medical device leading to a disruption of the sequence of events for activating or placing the medical device in a specific position or disconnecting it<\/td>\n\u041015<\/td>\n<\/tr>\n
Deviation from the design parameters of the medical device intended to reduce risks or maintain an acceptable level of risks for the patient or operator<\/td>\n\u041016<\/td>\n<\/tr>\n
Individual intolerance of the medical device by the patient<\/td>\n\u041017<\/td>\n<\/tr>\n
The presence of any foreign substance not provided for in the technical documentation in the medical device, on its surface or in the packaging, which may affect the efficiency of operation of the medical device or its use for its intended purpose, or which jeopardizes the effectiveness of disinfection of the medical device<\/td>\n\u041018<\/td>\n<\/tr>\n
Non-compliance of the environment with the conditions provided for in the technical documentation for the operation or storage of the medical device<\/td>\n\u041019<\/td>\n<\/tr>\n
Incorrect installation, adjustment of the medical device or its configurations<\/td>\n\u041020<\/td>\n<\/tr>\n
Labelling, instructions for use and documentation on training and maintenance of the medical device that do not correspond to the medical device<\/td>\n\u041021<\/td>\n<\/tr>\n
A result of the effect of the medical device on the patient not provided for by the manufacturer or operator<\/td>\n\u041022<\/td>\n<\/tr>\n
Errors in the maintenance, operation of the medical device that violate the manufacturer\u2019s recommendations<\/td>\n\u041023<\/td>\n<\/tr>\n
An event not related to the medical device<\/td>\n\u041024<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION FEDERAL SERVICE FOR SURVEILLANCE IN HEALTHCARE ORDER   dated 20 May 2021 N 4513   ON APPROVAL OF THE CLASSIFICATION OF ADVERSE EVENTS RELATED TO THE CIRCULATION OF MEDICAL DEVICES   In accordance with part 1 of Article 96 of Federal Law dated 21.11.2011 N 323-FL “On the […]<\/p>\n","protected":false},"featured_media":2339,"template":"","categories":[25],"class_list":["post-2485","resources","type-resources","status-publish","has-post-thumbnail","hentry","category-regulatory-framework-en"],"_links":{"self":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/resources\/2485","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/resources"}],"about":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/types\/resources"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/media\/2339"}],"wp:attachment":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/media?parent=2485"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/categories?post=2485"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}