Does the medicinal product licence holder need to comply with ISO 13485 ?

Answer:

As a product license holder (with no manufacturing responsibilities including primary assembly of products), you are not required to comply with ISO 13485 however your contract manufacturer has to comply with ISO 13485.

For further information, please look at the following article:
-What are the consequences of noncompliance with ISO 13485 for manufacturers of medical devices? https://advisera.com/13485academy/blog/2017/11/02/what-are-the-consequences-of-noncompliance-with-iso-13485-for-manufacturers-of-medical-devices/