Taller sobre requisitos técnicos de productos chinos (PTR) para pruebas
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
Al finalizar este taller, los participantes podrán:
- Comprender la importancia del Requisito Técnico del Producto (RTP) en las presentaciones regulatorias.
- Aprenda a redactar un PTR que cumpla con los requisitos y sea eficiente, alineado con las regulaciones globales y chinas.
- Gain insights into the role of PTR at type testing in the approval process.
- Develop strategies to manage revisions and align PTR with design changes.
- 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.
Como alternativa, existe una sesión de autoaprendizaje después de la reunión personal con el estudiante de caso.
Kit gratuito
Tras los talleres, el grupo recibirá un kit PTR con una plantilla útil, una matriz e instrucciones de trabajo.
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
Con cita previa.
Depende del nivel de comprensión y la dificultad del PTR chino, así como del número de participantes.
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.
