Registration certificate of Roszdravnadzor
The registration certificate is a document confirming the registration of medicinal drugs, medical products and allowing the manufacturing and circulation of these products in the territory of the Russian Federation. The availability of this certificate shows that medical products of the manufacturer or importer fully comply with all regulations and standards established by national legislation and can be used for their intended purpose without the risk of harming the life and health of consumers.
The registration of the certificate is carried out in several stages:
- Registration of the certificate recipient company in the Ministry of Health with a mandatory package of documents, including information about the company, products technical documentation and equipment manufacturer data;
- After the submittal of the documents, the medical products are inspected for compliance with the current quality standards, as well as with the requirements of the laws of the Russian Federation;
- A decision is made to issue the registration certificate or refuse. This stage can take from 3 to 4 months from the moment of submittal of the complete set of documents. In difficult situations, the processing period can be increased, but not more than for another 3 months.
To obtain the registration certificate for medical equipment and other medical products, the following package of documents must be submitted:
- An application or a cover letter sent to Roszdravnadzor (Federal Service for Surveillance in Healthcare and Social Development) for the registration of medical products or special equipment (notary certification is not required);
- Articles of incorporation of the company, which is engaged in the manufacturing of products (equipment);
- Power of attorney for the company operating in the territory of the Russian Federation and carrying out the registration of products (apostille and notary certification are mandatory);
- Certificate of state registration of a foreign manufacturer of medical products. The apostillation or certification of the document in the consulate of the Russian Federation, and notary certification are mandatory;
- ISO certificate, stating the conformity of products to the current requirements (apostille and notary certification are mandatory);
- A set of advertising products;
- Certificate for the product, which is subject to further distribution and application;
- Technical papers for the manufacturing of goods;
- Protocols of medical product testing results;
- Instructions or a complete guide of the products use;
- Other documents that may be needed to conduct a full product evaluation, taking into account the requirements of the laws of the Russian Federation.
For any inquiry regarding the obtaining the Roszdravnadzor Registration Certificate, you can contact our company. Specialists of «Unicert Group» will help to significantly facilitate and expedite the procedure for obtaining the registration certificate of Roszdravnadzor.