Medical device seller approval


#1

We listed Back Brace on AMAZON UK marketplace, after we sent the goods to AMAZON FBA warehouse, they unlisted our goods and require us to apply for seller approval. As their instruction, we submitted Purchase invoice, ISO 13485 certificate, and products packagings images. But the seller approval team always refused our selling request. The main reason seems the packaging not meet their requirement. But we have put Manufacture’s name, address and model No. on the packaging. we are really confused what should we do.


#2

A “back brace” is still deemed a Class 1 medical device requiring approval;

https://www.gov.uk/government/collections/guidance-on-class-1-medical-devices