Registration certificate of Ministry of Health
Without fail the producer of medical equipment, products of the medical appointment which application is planned for territories of the Russian Federation has to have a certificate of Ministry of Health. Without the certificate use of specified production in the Russian Federation is impossible.
The document gives the chance to the consumer to make sure that production safe and qualitative, and is brought in the Register of medical equipment and medical products.
Carry out registration after carrying out the toxicological, clinical, technical and other researches, which purpose – confirmation of safety of production.
The certificate addressed to the manufacturing organization is made out.
The registration certificate of Ministry of Health grants the right to the producer to use tax privileges – Art. 149, item 2, subitem 1 of the Tax Code of the Russian Federation. The tax doesn’t assess such types of production:
- the materials which are applying to rehabilitation of people with limited opportunities, for the disability prevention: artificial limbs, semi-finished products, raw materials for their production, technical means for disabled people;
- vital medical equipment. Its list is in the Government resolution No. 19 of 17.01.02;
- points, lenses and frames for them (except sunglasses).
How registration of the certificate of Ministry of Health is carried out
Carry out certificate registration as follows:
- documents submit an application for medical products also. Documents pass examination;
- production researches are conducted;
- expertize of the statements which have been drawn up by results of researches is carried out;
- registration of products, issue of the Registration certificate is carried out;
- the medical production which has passed examination, is brought in the State registry of medical products.
Documents which are necessary for registration of the certificate
The main documents which the applicant for obtaining the certificate has to submit:
- the document confirming payment of the state tax;
- the documents confirming registration of the manufacturing enterprise as the legal entity;
- the power of attorney or the contract copy – is provided if the authorized representative, instead of the producer is engaged in registration;
- the documents proving that declared medical production and conditions of its production conform to standards or specifications;
- certificate of a product of medical appointment;
- product operating instructions.
Provided documents have to be in Russian. If the producer is the nonresident of the Russian Federation, has to be enclosed notarized transfer.