How to get condom import license?
Latex condom as IIB medical device, which cares consumer’s health and HIV Aids, so authority always takes strict measures to make sure all the import condoms must up to some certain standards. The first step is to get the import license.
The authority who control condom always has different name in each country, such as USA is FDA, China is SFDA, Egypt and Russia is MOH, South Africa is SABS, and Nigeria is NAFDAC. In order to make sure all the imported condom up to their minimum standards, they need the importer must register at first.
How to register?
Authority always ask importer prepare followings files to them:
A: Cooperation agreement or power of attorney or Authorize letter from manufacturer.
B: Manufacturer’s quality certificates, the main is ISO13485 and CE.
C: Manufacturer’s Free sale certificates, most countries accept China SFDA’s Free sale certificate, but it seems Egypt authority only accept European free sale certificate, our company also can supply.
The above 3 files are main files, but some countries always has special requirements, we also can cooperate closely to make sure all files are ok. And some main files also need destination country’s embassy legalization.
A: If importer has own brand name, they need send the brand condom sample to record in authority’s warehouse, they will track quality for following order by it. If need own brand sample, the importer need place a sample trial order to the manufacturer at first.
B: Some countries don’t need the branded sample, maybe similar quality condom is ok, but the importer must make sure the sample from the manufacturer.
When we send the files and samples to the authority and they accept it, our next work is wait their final signature, it maybe need 1 to 6 months, different countries has different time.
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