Medical device condom registration need FDA approval.

As condom belong to Class IIb Medical Device. If you plan to deal with condom business. You need to register condom from your country Food and Drug Administration. You can consult a register specialist to register or directly ask your local Ministry Of Health Department the process of registration. Products in Medical Device has to meet special labeling requirements and performance standards. They will ask you to supply the official documents, Such as Power of Authority, Technical file, Quality certificate, Clinical studies, ISO standard. Some papers need signed by office department. Some MOH may ask you to supply the sample to test. For condoms, the Food And Drug Administration will test the sample with some testes include systematic “water leak” tests to ensure that no fluid can leak out of the condoms. All our condoms are CE approved with high quality. If you want to register condom, we can help you finish the registration. Any requests, please feel free to contact us. Email: linda@oemcondoms.com