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
---
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.
---
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
Центр сертификации EAC Таможенного союза 沪ICP备10027014号-14
地址:上海浦东新区高科东路777号1号楼2017室 021-36411223 021-36411293 skype: gostchina
E-mail: eac@cu-tr.org 微信和手机:18621862553 海关编码查询 沪ICP备10027014号-3
网站内容和图片版权所有,未经允许,不得转载复制拷贝和使用 海关编码