Workshop of Chinese product technical requirement (PTR) for testing

What is product technical requirement (PTR)

Product technical requirement (PTR) is a document submitted to testing institutes (or Chinese labs) by legal manufacturers. As annex in Chinese certificate, it is a characteristic part of medical device indicating all key performance specifications and testing methods derived from Chinese standards. PTR is on critical document among submitted dossier.

Why is PTR important

Specification of PTR is one of biggest finding during inspection of medical device in field in China and at overseas inspection.

Besides the specification at PTR and testing method should be integrated in early design and proved. At three inspections at production, the specifications of PTR should be selectively controlled and tested.

Learning content

By the end of this workshop, participants will:

1. Understand the significance of the Product Technical Requirement (PTR) in regulatory submissions.
2. Learn how to draft a compliant and efficient PTR aligned with global and Chinese regulations.
3. Gain insights into the role of PTR at type testing in the approval process.
4. Develop strategies to manage revisions and align PTR with design changes.
5. Specification of PTR as evidence in R&D and QC

Alternative there is before workshops a self-assessment to know the understanding of PTR. It is ideally if manufacturer shows current PTR of approved medical device.

Alternative there is self-study session after personal meet up with case study

Free-kit

After workshops the group will get a PTR-kit with useful template, matrix and work instruction.

Audience

The workshop is aimed at employees of medical device manufacturers who are involved in the creation of the PTR. The primary audience is regulatory affairs manager, but also for people from the areas of development, product management, quality management and regulatory affairs.

It is also suitable for manufacturers without experience of Chinese registration.

Cost and duration

By arrangement.

It depends on level of understanding and trouble of Chinese PTR and also number of participants.

Normally we have 2 sessions with one case study at first session of workshop.



The workshop can be remotely and personally in Europe around Germany.