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.

Our Approach

One of Cisema’s key competencies is drafting a compliant and accurate PTR which will form the basis for local type testing, and then the dossier submission to the NMPA.

Key content of the PTR includes product name, description of the product, performance indicator, test methods, main raw materials and production process (where relevant).

Once the product receivals approval from the NMPA, hospitals and distributors will often want to see the PTR to support their purchasing decisions.

Whilst the PTR is not publicly available (unlike the NMPA certificate itself which information can be found on the NMPA website) it is possible to make an application to the NMPA for disclosure of the PTR. However, companies when producing the PTR in response to such information requests may cover up sensitive or confidential information.



Contact us at +1 (0)773-449 5169 (US & Americas) or + 49 (0)89-4161 7389-00 (EU and worldwide) or via email if you would like to learn more about the PTR, information requests or NMPA registration of your product.

To obtain further relevant information we recommend you to visit our knowledge area or our registration page for exclusive information brochures.