Amendments to registration certificate of medical device in the EAEU-bg

Amendments to registration certificate of medical device in the EAEU

The procedure for making amendments to the registration dossier for medical devices registered under the EAEU rules is prescribed in Decision of the EEU Council of 12 February 2016 No. 46 "On the Rules for Registration and Expert Examination of the Safety, Quality and Effectiveness of Medical Devices", in Sections V and VI. In contrast to the national system of the Russian Federation, the EAEU has a procedure for making amendments in notification manner. It is applicable in the following cases: -changes in the validity period of dossier documents -Changes for medical device of potential risk classes 1 and 2a, for manufacturers who have received an assessment of the quality management system -Change of information on the manufacturer -Change of information on AR -changes of medical device trademark name -exclusion of medical device models from the RC. To make these amendments, the manufacturer sends to the authorized body a statement for amendments and supporting documents. Amendments to the registration dossier in the notification manner shall be made within 15 working days from the date of the decision to begin the procedure of amendments to the registration dossier in the notification manner. If the procedure of making amendments in the notification manner is not applicable, the manufacturer shall go through the procedure of making amendments with the agreement of the expert conclusion with the states of recognition specified in the registration certificate. The examination of the documents by the authorized body is conducted within 30 working days from the date of the decision on the beginning of the procedure of amendments, further the conclusion must be agreed by all countries of recognition. In case of disagreement of the conclusion by any country of recognition, it can be excluded from the RС. The manufacturer is obliged to notify the Authorized Body of the amendments in time, namely within a period not exceeding 90 calendar days from the date of the amendments and provide the relevant documents. The EAEU Rules also contain specific cases when amendments cannot be made and a new registration is required. These cases are: -changing the functional purpose or principle of action of the medical device -Addition of models that do not comply with the criteria for inclusion in a single RC -simultaneous change of information about the manufacturer and the manufacturing site, except for information about the legal form, address, reorganization, and other information contained in the statutory documents. In order to make amendments under the EAEU rules, as in the national system, an obligatory condition is the submission of the original RC to Roszdravnadzor.

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