The decision concerning circulation of medical devices, being of importance for native manufacturers of medical products (medical equipment and medical devices), authorized representatives of foreign manufacturers, and importers of medical products was legislated in the beginning of 2015. Resolution of the Council of Ministers of the Republic of Belarus No. 1287 dated December 31, 2014 On Annulling Resolutions of the Council of Ministers of the Republic of Belarus as of January 01, 2015 has cancelled technical regulations of the Republic of Belarus TR 2010/006/BY Medical Products. Safety, approved by Resolution of the Council of Ministers of the Republic of Belarus No. 774 dated May 24, 2010, which was developed in terms of medical products safety.
For the purposes of performing coordinated policy in the field of circulation of medical products within the Eurasian Economic Union and implementation of Article 31 and Clause 2, Article 100 of the Treaty on the Eurasian Economic Union dated May 29, 2014, the Agreement on Unified Principles and Circulation Regulations of Medical Products (Medical Devices and Medical Equipment) was signed on December 23, 2014. According to Clause 2, Article 100 of the Treaty the common market of medicinal products within the Eurasian Economic Union shall start functioning as of January 01, 2016.
Until documents of the Eurasian Economic Union regulating circulation of medical products come into effect, marketing and medical use of medical equipment and medical devices shall be performed according to national law after the state registration procedure carried out by the Ministry of Health of the Republic of Belarus. According to regulatory documents in force products, registered as medical equipment or medical devices and authorised for medical use, shall not be subject to obligatory certification and declaration in the National System for Conformity Attestation in the territory of the Republic of Belarus.
However it should be considered that according to Decision of the Customs Union Commission No. 879 dated December 09, 2011 technical regulations of the Customs Union TR CU 020/2011 Electromagnetic Compatibility of Technical Equipment has come into force as of February 15, 2013. Taking into account that medical products are included into the Unified List of Products, in terms of which obligatory requirements are set within the Customs Union (approved by Decision of the Customs Union Commission No. 526 dated January 28, 2011), they are covered by these technical regulations of the Customs Union. Medical products, which may be referred to technical equipment capable of creating electromagnetic interference and (or) the performance quality of which depends on influence of external electromagnetic interference, shall be subject to conformity attestation against requirements of technical regulations of the Customs Union TR CU 020/2011 Electromagnetic Compatibility of Technical Equipment in the form of conformity declaration.