EAC marking is a conformity mark put on products (or packing, label, regulatory documents) to indicate approval of the product by requirements set by law. Apart from safety and quality...
A document confirming the quality and safety of medical devices and equipment is issued after their successful registration – the Ministry of Health registration certificate. This procedure is performed in accordance with the Order of the Ministry of Health to monitor the sphere of social development and supervise the registration of medical devices (Order № 735 of 30th October, 2006).
If the Ministry of Health registration certificate has not been issued for the product and yet it requires a compulsory state registration, its implementation and application in medical practice is strictly prohibited. Violation of these requirements is illegal. The Federal Service for the Supervision of Public Health and Social Development (Roszdravnadzor) is responsible for making sure that this law is respected.
The list of goods that require the Ministry of Health registration certificate
According to the established norms of the Ministry of Health and Social Development, the registration certificate is issued for:
- medical hardware and software;
- other products, devices and equipment used for treatment, prevention and other medical purposes.
The procedure for obtaining the Ministry of Health registration certificate
The execution of the Ministry of Health registration certificate starts with filling in an application on our website and then completing laboratory tests in accredited centers. Testing is needed to make sure that the goods comply with the requirements, are efficient and safe to be used for medicinal purposes. Subsequently, the staff of the certification center “Rostest Latvia” will analyse the protocols and prepare all the necessary documents for obtaining the Ministry of Health registration certificate.
Each registration certificate of the Ministry of Health receives a unique registry number.
We invite you to seek professional advice and support in the preparation of documents for obtaining the Ministry of Health registration certificate in our center, “Rostest Latvia”.