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白俄罗斯医疗器械注册 白俄罗斯共和国第2435-XII号“医疗保健法
来源: | 作者:pmt1ac5e9 | 发布时间 :2019-06-03 | 2192 次浏览: | 分享到:
白俄罗斯医疗器械注册 registration of honey products Belarus,在白俄罗斯医疗器械注册是强制性程序。注册活动包括质量控制,安全和效率。白俄罗斯共和国第2435-XII号“医疗保健法”于2008年6月18日和白俄罗斯共和国部长理事会2008年8月2日第1269号决议“关于批准医疗产品和医疗设备的国家注册(重新注册)”中规定了白俄罗斯作为国家注册医疗器械的规则。技术要点和要求见相关法规。


The certificate is valid for 5 years. It is made out on the form of the established sample with protection. The preliminary technical work is carried out by the Center for Expertise and Testing in Health Care, its specialists determine the need and type of testing based on the data obtained from the documentation. The same organization issues an opinion and is responsible for maintaining the identity registry. The ministerial commission can stop the registration of medical devices in Belarus if there is a lack of any data confirming the safety, efficiency and quality of the products presented.

Important: The presence of a registration certificate for a specific medical device is a prerequisite for obtaining tax benefits.

Documents for registration of medical devices
Domestic production:

Application for registration.
Technical regulations from the manufacturer with the method of verification.
Protocols and (or) acts of technical tests.
Protocols and (or) acts of sanitary and hygienic tests.
Protocols and (or) acts of clinical trials.
Instructions for use on a specific product model.
Conclusion
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When to re-register
It is necessary to contact the specialized organization for the official renewal of the certificate. Re-registration pass, if:

the validity period of the previously received certificate of registration has expired;
product name has changed;
the manufacturer has changed the name or there was a reorganization;
production country has changed;
Amendments to the technical regulations for the medical device have been made.
These reasons for re-registration of medical devices are described in the above Resolution of the Council of Ministers of the Republic of Belarus.

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How to more effectively and faster to register
To register the registration of medical products in Belarus as soon as possible, it is important to gather all the necessary documentation. This will avoid comments after the initial examination, which requires time-consuming repairs. Additionally, you can contact the experts with experience in this field. In other countries, different organizations are engaged in this, so qualified assistance for those who want to enter the international market will be extremely useful. Indeed, each country has its own list of goods subject to the CGR (state registration).

 registration of honey products Belarus