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License for production of medical equipment

License for production of medical equipment

We conduct legal examination and preparation of all required documents to obtain a necessary license.

To obtain a license for the production of medical equipment you need to submit the following documents:

1. Document confirming payment of license fee for consideration by the licensing authority an application for a license.

Cost- (300 rubles). The sample will be provided.
2. Copies of all Founding documents with all amendments and supplements
3.Passport copy of individual entrepreneur.
4. Copies of documents proving ownership or other legal basis for the use of buildings, facilities and equipment for the licensed activity.
5. Copies of documents proving the relevant licensing requirements and conditions of qualification and experience of specialists responsible for the production and quality of medical equipment.
6. Copies of patents of Russian Federation and (or) license agreements that allow the production and sale of proprietary medical technology in Russia.
7. Copies of documents confirming registration in Russian Federation of medical equipment, which applicant is willing to produce.
8. Copies of normative and technical documents for production and quality control of medical equipment.
9. Copies of documents showing verification and (or) the calibration of measuring instruments in accordance with requirements of Articles 15 and 23 of the Russian Federation Law "On ensuring the unity of measurements.
10. The range of manufactured medical equipment.
11. Proof of the professional skills for the stuff, responsible for production and quality of medical equipment, with attached copies of diplomas, technical education and employment record books with copies of proof of relevant work experience at least 3 years.
12. Proof of the professional advance training for the stuff responsible for the production and quality control of medical equipment at least once every five years with attached copies of licenses, certificates, licenses 13.Proof of logistical equipping ( financial and technical).

Copies of documents are not notarized, shall be submitted with the presentation of the original.
The cost of a standard set of services: 91 300 rubles
Deadline: 45 working days

Address: Moscow
Phone: +7 495 549 84 46, 7 906 797 46 46

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License for production of medical equipment