When you plan sell condom at your market, you need to register at your authority at first to get the license, because condom belong to IIB Medical product. The authority will ask a file list and sample, some countries also need to arrange officers to inspect in site to check if all the process comply to the files.
Following is Russia Authority’s file list requirements, different authority always has different files requirements, this list only for your reference:
- Information on the registered medical device (hereinafter − MD): name, basic ingredients, and accessories.
- Documents confirming incorporation of legal entities (designer, manufacturer, production site, holder of the registration certificate) (extract from the trade register, Establishment, another document on incorporation).
- Documents confirming compliance by the foreign manufacturer with international ISO standards (ISO 13485 and ISO 9001).
- Documents confirming compliance by the foreign manufacturer with 93/42/EEC international standards (CE Certificate).
- Documents confirming compliance of the medical device with its requirements (Declaration of Conformity, Free Sale).
- Documents confirming interrelation between the designer, the production sites, the holder of the registration certificate and the manufacturer (Certificate of Free Sale, Partnership Agreement, another document).
- Power of attorney issued by the manufacturing company to the Authorized Representative in the Russian Federation and granting the right to represent interests of the manufacturer relating to full circulation of the MD (including the scope of powers specified in Article 38 of Federal Law of the Russian Federation No. 323-FZ of November 21, 2011).
- Extract from the Uniform State Register of Legal Entities relating to the applicant (Authorized Representative of the manufacturer in the Russian Federation).
- Technical documents on the MD, including: 9.1 all specifications of the MD (including accessories); 9.2materials used to manufacture the MD, including material grades and producers; 9.3list of materials of animal and (or) human origin, indicating information on their biological compatibility and safety, selection of sources (donors), sampling, processing, storing and handling these materials (if applicable to the MD); 9.4information on validation and verification of the medical device used to confirm compliance of the MD with the requirements, including Test reports of the manufacturer – engineering tests, tests of the device as a measuring device, for electrical medical devices – electromagnetic compatibility test certificate); 9.5information on the basic stages of designing the MD and manufacturing processes (process flowchart with description of the stages); 9.6information on a therapeutic agent and pharmaceutical substance contained in the MD, according to the State Register of Medicines (if applicable to the MD); 9.7information on design, development and validation of the software used by the MD, as well as its version and date (if any); 9.8 shop drawings, tables and charts, if they are not included in the operational documents (Product Manufacturing Flowchart and QC Process); 9.9 information on joint application with other MDs, compatibility requirements.
- Operational documents of the manufacturer on the medical device (IFU, Operation Manual) includingdescription (inter alia − accessories), application, contraindications and negative side effects, warnings, terms and method of application, list of consumables, information on joint application with other MDs, maintenance, repair, recycling method, manufacturer warranty, conditions of operation, handling and storage, assembly and installation of the MD.
No. 5 is the request of free sale certificate, which means the product not only can free sale at producer’s local market, which also can free sales at imported market. Following is a standard version of our company’s free sale certificate:
Peoples republic of China
Certificate for Exportation of Medical Products
Certificate No. ：2014081801
Manufacturer：Shandong Ming Yuan Latex Co., Ltd
Address of manufacturer ：Middle of Licheng Road, Development Zone Of Linyi County Dezhou, Shandong China 251500
Exporter：Shandong Ming Yuan Latex Co., Ltd
Address of Exporter：Middle of Licheng Road, Development Zone Of Linyi County Dezhou, Shandong China 251500
This is to certify that the above product(s) comply with the relevant standards of the People’s Republic of China, have been registered and are allowed to be sold on the market of China. The exportation of the product(s) is not restricted.
China Food and Drug Administration,
Medical Device Regulator
2022/ 04/ 02
（This certificate is valid for two years from the date of issuance）