EEC approved several documents regarding medical devices circulation

| By | EEC, Medical Devices Manufacturing
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On August 21, the Board of the Eurasian Economic Commission (EEC) approved the draft Memorandum of Understanding between EEC and the Global Medical Device Nomenclature Agency.

The Agency forms and maintains internationally recognized generic descriptors used to identify all medical device products. More than 70 national regulators of medical devices now use the global nomenclature.

Within the framework of the Memorandum, it is planned to update the nomenclature of the medical devices in EAEC in accordance with the changes in the Global Nomenclature, exchange information and experience, hold joint meetings, consultations, scientific and practical seminars and conferences on issues of mutual interest.

The implementation of the memorandum will help harmonize the nomenclature of the medical devices in EAEC with the Global Nomenclature, establish cooperation in the classification of medical products of the Parties, and improve their nomenclatures.

There were also approved the handbook of the types of changes introduced into the registration dossier of a medical device and a classifier of the types of documents to be drawn up when considering the registration dossier of a medical device.

The handbook and the classifier are included in the resources of the unified system of normative and reference information of the EAEC. The use of the codes from the handbook and the classifier is mandatory in the implementation of the general processes in the Union in the sphere of the circulation of medical products.

The handbook is based on the coding information on types of changes to the registration dossier of a medical device in accordance with the Rules for Registration and Examination of Safety, Quality and Efficiency of Medical Products. Classifier is based on the coding of information regarding the types of documents to be drawn up when examining the registration dossier of a medical device.

The approved documents are expected to be used for electronic communication between the authorized bodies of the EAEC countries, including the formation, maintenance and use of a single register of medical products registered in the Union, as well as in the formation of statements on the fulfilment of the procedures set in the Registration Rules.

VIArussian version
SOURCE: eec
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