Compliance

The condom is considered a Class IIb medical device, it is subject to certain legal requirements.

In Europe, the condom must have CE ISO 4074:2002 standard and must be packed and / or stored in a workshop with the ISO 13485 certification.

The condom should always be accompanied by an instruction manual and aluminum case must be protected by a overpack. This is why the pouch is essential, it protects the condom and instructions are printed on the inside of it.

The particulars must be legible and understandable by the user, that is to say that the language used in the operating instructions should be those of the country and / or the broadcast group.

Outside the wallet must contain the content, expiry date, batch number, the number of the CE and the name and address of the manufacturer and / or importer of condoms. The foil condom should appear the number of CE, expiration date and lot number.

NF (French Standard) standard is not mandatory for the distribution of condoms in the French territory.

In the U.S., the condom must meet the FDA standard. The principle is the same, but additional information is to be added to the inside and outside of the pouch. The authorization number from the FDA (Food and Drug Administration) is also required.

We are in relationships with different qualities and legal services for manufacturers to be able to advise you better.

The languages of instruction manual

Depending on the country in which the condom packages are to be distributed, the law requires the use of certain languages for "hot-to" instructions. For example, in a country like Belgium or Switzerland, where there are three official languages, it is recommended that the instructions be given in these three languages. For distribution in Germany or France, only one language is sufficient. For widespread European distribution, it is recommended to use German, English, Spanish and French.

Depending on the condom brand, you may choose any of the following languages: AR, BG, CZ, DE, DK, EN, ES, EST, FI, FR, GR, HK, HR, HU, IS, IT, LT, LV, NL, NO, PL, PT, RO, RU, SE, SK, SLO, SRB, TR ... 

Our packages provide enough space for legal notices to appear in 4 to 5 languages at most.

Compliance
ISO 13485 Certification ISO 13485 Certification
ISO 9001 Certification ISO 9001 Certification