A question I have been asked is: To what extent is ISO 13485:2016 applicable to distributors of medical devices? They import devices and sell them locally as is.
The answer to this question depends on answers to the following questions.
- Are you marketing the medical devices that you sell? What claims do you make in your marketing and can you show verifiable evidence from the manufacturer/supplier that the medical device actually satisfies those claims?
- Are you providing any training regarding installation, set up and configuration, operation or maintenance of the device?
- Are you providing after-sales support of any kind?
- How do you track and handle recalls?
- Do you do any kind of inspection or sampling to ensure that the devices you receive function correctly before shipment or collection of the device?
- Are the medical devices approved for import and sale by you in the country in which you operate?
- What is the medical device classification in your country of operation?
- Are you registered with a healthcare regulator as an importer/distributor? What healthcare laws and regulations are you subject to? How do you demonstrate compliance?
- What technical or professional competence is required or expected of your staff? Do they actually have the required training or experience?
- To the extent that any of the above apply to you, what processes do you have in place to ensure quality and compliance?
- What records can you show as evidence of quality, consistent conformity with the above answers or compliance with healthcare regulations?
These questions and their answers are all relevant to ISO 13485:2016. I am sure other people in the industry could think of still more questions.