When you plan import condom into the Russian market, No matter you are new brand or long history brand condom, you have to prepare the condom registration in Russia as following this process, following files need prepared, and some files need embassy notary apostille, The list of documents to be transferred by the Customer to the Contractor in order to provide services for the registration of foreign-made medical devices (MD):
The conformity assessment of medical devices ( condom belong to IIB Medical) is a mandatory procedure of state supervision. By conducting this procedure, the fulfillment of safety and quality requirements shall be assessed. Following the conformity assessment, a certificate in form of a state registration of medical devices is issued in order to confirm that the medical products are in compliance with the minimum requirements of the technical regulation in Russia.
List of documents to be transferred by the Customer
- 1: Summary Technical Document (STED) , also named Technical file of condom.
- 2: Technical parameters and characteristics of MD (Medical Device of condom) and accessories.
- 3: Materials from which MD (Medical Device of condom) is made, indicating the brand of materials and manufacturers (for products that have contact with a person, condom need contact with consumers directly)
- 4: A list of materials of animal and (or) human origin with information on their biological compatibility and safety, on the selection of sources (donors), sampling, processing, storage and handling of these materials (if applicable to this MD), does the ingredient casein belong to this file?
- 5: The scheme of the production process with a description of the stages and stages, Please send a diagram describing the stages of production, the flow chart of condom production.
- 6: List of medicines, pharmaceutical substances (if applicable to this MD) Due to what is the prolonging effect of the Long Love product created? Lidocaine, menthol or something else? or the spercimide as N9 which will kill the sperms, or any others material of chemical, such as warming or cooling condoms.
- 7: Drawings, tables and diagrams of condom, basic introduction of the condom such as the size, shapes and packing data.
- 8: Information on joint use with other MD, compatibility requirements, Is this product intended to be used with another product? For example, additional lubrication or something else.
- 9: Risk management file (compliance with ISO 14971 requirements)
- 10: The list of all standards that the condom complies with.
- 11: Clinical Evaluation Report + Post-marketing surveillance (ISO/TR 20416:2020)
- 12: Passports/quality certificates for the material/substances included in the implantable MD (for implantable products). Please send MSDS, certificate of analysis for the materials from which the product is made (latex, silicone grease, dyes, flavors, individual packaging material and other materials)
- 13: Marking layouts, description of marking symbols, Please send labels for individual and group packaging.
- 14: Manufacturer’s operational documentation for MD (IFU), Directions for Use – with the purpose, indications, contraindications.
- 15: Documents confirming the registration of organizations (developer, manufacturer, places of production, holder of a registration certificate in the Russian Federation) (Extract from the trade register, Establishment, Business license).
- 16: Documents confirming compliance of foreign production with international standards ISO 13485
- 17: Audit Report on the inspection of production to the ISO 13485 standard.
- 18: Documents confirming compliance of foreign production with international standards 93/42/EEC (CE Certificate) (if available)
- 19: Documents confirming the compliance of the medical device with its requirements (Declaration of Conformity, Free Sale) (if available)
- 20: A power of attorney from the manufacturing organization to an Authorized representative in the Russian Federation with the right to represent the interests of the manufacturer on issues of full treatment of MD (with the terms of reference specified in Article 38 of Federal Law of the Russian Federation No. 323-FZ of 21.11.2011).
The documents 15-20 shall be submitted on paper with an apostille or consular legalization (except for documents whose country of origin is a country with which Russia has concluded a bilateral treaty abolishing the requirement of legalization), translated into Russian, with notarial certification of the translation.