Regulatory Guidance for Medical Device of Condom’s importing

Importing medical device into a new market need the registration in authority of MOH or FDA. As latex condom belong to Class IIb Medical Device, So it also need to comply with the regulatory guidance. If you plan to deal with condom business. You need to register condom at local market’s country Food and Drug Administration or Ministry of health. 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 some official documents, And give you a list of files requirements, and then we can prepare accordingly. Such as Power of Authority, Technical file, Quality certificate, Clinical studies, ISO standard. Some papers need signed by office department. Different countries has different requirements, and same government also has different files request even at different time. 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.

And our company also has lubricants production, which not belong to any medical regulation, so clients can buy it freely. We can custom make the lube in clients own packs, and JL glass is our supplier of the container for lube, so we can offer clients various types of lubricant.

If you want to register condom at your authority, we can help you finish the registration and help you prepare the files and samples. Any requests, please feel free to contact us. Email: [email protected]   or  [email protected]

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