What is the China PTR?
The Product Technical Requirements (PTR) are an appendix to the NMPA certificate for each product. It contains key details relating to the product and is the fundamental documentation throughout the registration process as well as for post-market sales support and ongoing regulatory requirements.
There are specific guidelines regarding content and formatting requirements for the PTR contained in the Guidelines for the Preparation of the Technical Requirements of Medical Device Products (2014: No. 9) issued by the NMPA.