Your Blueprint to the Product Technical Requirements (PTR)

You received a notification from your China representative that the initial registration was returned with a deficiency note. You swallow a gulp of saliva before reading it…

You cannot help but question yourself, “What did I miss? I submitted all EU/US-issued documents from the Notified Body or the US FDA authority. Why were my IEC test reports not accepted?”

Many countries accept the registration and technical dossier used for the reference GHTF countries. But, this is not always the case.

Some countries have specific local requirements and standards that you need to comply with. Having a market authorization in the country of origin doesn’t automatically guarantee success in other countries.

One of the main questions and deficiencies raised by NMPA is the Product Technical Requirements (PTR). According to the NMPA statistics for 2023, ALMOST ALL APPLICANTS (99.4% ‼️) of Class II medical devices received a supplementary letter with deficiencies on the PTR!

Below is the list of categories for which NMPA mostly raised questions or deficiencies during the initial medical device registration.

NMPA commonly requests additional revision and evidence on the PTR and clinical evaluation due to its high stakes on patient safety, risks, effectiveness and performance.

What is PTR all about?

A PTR consists of basic information about the medical devices and associated software, technical specifications, and testing methods of the performance indicators.

This includes the specifications following the local electrical safety, electromagnetic compatibility (EMC) and performance indexes.

The PTR is used to demonstrate that your devices meet the stipulated standards and requirements. This will be the output evidence that your device is safe and operates as intended to the claimed performance.

PTR is one of the core documents that all applicants need to submit to fulfill the list of required documents as well as to receive medical device approval in China. The testing lab does the electrical safety, EMC, and performance testing items based on the provided PTR.

What should you include in a PTR?

• Product name, model, specification, and product category (if needed). Describe the specifications of different models if multiple models exist under the same registration. You can use either a graphic or a table to illustrate.

• Performance indicators and testing methods of the finished products. Test methods should be adapted to the corresponding performance indicators. The priority should be given to the use of applicable standard methods that have been established. If necessary, you should perform methodological verification to ensure that the test method is reproducible. The details on the test principle, test steps, sample preparation and preservation, instrumentation, etc. can also be added to ensure that the results can be reproduced under every condition.

• The relevant Chinese National and Industry Standards (mandatory and recommended), as well as the Chinese Pharmacopoeia (if applicable). Refer to this post if you want to read more about Chinese standards.

• Appendices to outline additional product features or requirements. For instance, a description of the product characteristics, such as whether the devices are supplied in a sterile or non-sterile state, shelf life, main raw material, production process, and safety features that may affect the safety and performance of the medical devices.

• Software release version and naming rule (if applicable).

The performance indicators shall allow the objective assessment of the functional, safety, and quality aspects of the finished medical devices.

The applicant shall refer to the relevant National and Industry Standards for the technical requirements that match the design features and intended use of the medical devices.

However, not all testing methods of performance criteria are covered or available under Chinese standards. There are scenarios where the structural characteristics, intended use, scope of application and etc. are not within the scope of the Mandatory Standards.

In this case, the applicant should provide an explanation and relevant information to support the claims of why the Mandatory Standards are not applicable.

What else should I know about PTR?

• PTR shall be compiled in Simplified Chinese for the submission. You can create a copy of the unofficial translation in English (for example) for internal reference of non-Chinese speakers.

• If the original product name is in other languages, it must be translated into Simplified Chinese unless it is a trademark. The chosen product name in the PTR should also be identical to the product name for the registration filing/ submission.

• The exact relevant standard number and year must be provided when referring to the National and Industry Standards.

• PTR should clearly outline all the performance indicators. The addition of a note, such as “Please refer accompanying documents.” is not accepted. The content should be clear and straightforward. Do not play peek-a-boo with the reviewers. Your application will be smoother if you make their review work easier!

• The field to insert the PTR number can be left empty, as the information corresponds to the registration approval number.

What should you exclude from the performance indicators?

You do not need to list the criteria in the performance indicators section within PTR if they do not significantly affect the product's safety and effectiveness. Too much information can also harm. The following are NOT RECOMMENDED to be included under performance indicators:

1. Research and validation data that you obtained and performed during the design and development phase

• Accelerated ageing test on the shelf-life ❌

• Storage, shipping and packaging conditions ❌

2. Data not related to the non-finished product

• Chemical characteristics of raw materials❌

• Performance indicators of non-finished product ❌

These verification and validation data should be addressed under the different sections of the submission dossiers. Try not to have duplicate information in different documents. You may forget to update or align all the references mentioned across multiple submission documents.

It is crucial to have a team that knows the technical and product aspects when compiling a PTR with all relevant performance indicators. PTR is like a tour guide with a map that guides the testers to perform testing.

Take some time to understand what standards are available in China. Try to apply Chinese standards to your products if there are relevant standards that align with the scope. This ensures your products meet local requirements and minimize the potential questions from NMPA in regards to the proposed testing methods.

Almost every applicant gets questions on the PTR. So, it is not the end of the world if you need to revise PTR or perform additional tests. You got this!

Subscribe to my newsletter now if you haven't! This is the source of dopamine that keeps me motivated to deliver more nutritional content for you 😇.

Got any questions or feedback? Drop me an email at [email protected] or reply directly to the email that you received.

Disclaimer: This content is created solely in my personal interest and do not reflect the views, opinions, or policies of my employer or any other organizations I am affiliated with. The information provided is for informational purposes and should not be construed as professional advice. Neither I nor my employer is liable for any use of this content. This newsletter is non-commercial and does not compete with my employer’s interests. Any references to regulatory updates or guidance are based on publicly available information and are not intended to infringe upon proprietary or confidential content.