Is it enough to only follow regulations from Colombia? Does the USA impose any restrictions?
You need the same approvals as if it was being sold in the USA. It is a long and expensive process.
Columbia regulations seem to lean on EU regulations, especially the Medical Device Directive (MDD), or Directive 93/42/EEC, respectively, as regards risk classification. Especially in this regard, EU regulations are different from US regulations!
However, approvals from other countries (like US) seem to facilitate the national Columbian process.
Maybe this link helps you: http://www.emergogroup.com/resources/colombia-process-chart
Generally, you want your primary manufacturing facility to be ISO 13485 certified. In the cases of a minor component through a subcontractor, this isn't mandatory, but your life will be much easier with ISO 13485 certified manufacturers. You do not actually need any formal FDA clearance to manufacture in the US and sell overseas, but you will need the clearance from the recipient country (commonly CE Mark), and if manufacturing in the US, should register with FDA.
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