All importers will be required to be certified to ISO13485 in the next 36 months. This can be under an umbrella multi-national certificate or an individual certificate.
There is a local arm of a multinational that wants to know if their European principal’s QMS covers them or if they would need their own QMS as a subsidiary of the multinational. I enquired if they are subject to the principal’s QMS and they indicated that they are not as they are only the importer and do not manufacture locally but the international principal holds the ISAO13485 accreditation across its entire range of products (which makes sense because the company is ISO accredited and not the products themselves). Does the local subsidiary need to be listed on the international principal’s ISO accreditation or have its own?
This Article Also Answers the Following Questions :
- Do I need ISO13485 certificate to trade in medical devices?
- Are local distributors required to have ISO13485 certificates?