Chinese landscape of critical process for medical device

Chinese own process needed?

As we prepare for overseas inspection of Chinese authority, manufacturers like to integrate process in existing process. It is possible however for some key processes is too complex for authority to pick up Chinese requirements.

Besides possible mentioning of Chinese process in superordinate SOP or working instruction, we suggest manufacturer to have own process of

• Product technical requirement
• Type testing
• Documentación técnica
• Inspección final en producción
• Post market surveillance

Focuses of Chinese dossier

As workflow for registration we illustrate type testing and clinical evaluation (trial) which takes many efforts. Besides depending on product types there are challenges as

• Etiquetado chino
• Chinese essential requirement
• Archivo de software
• Shelf life validation
• V&V test compliant t product specific guidance.
• Exact these critical parts must be taken into prioritised account. 

Agile management of product registration

There are not many typical steps in project management as step 1 followed by step 2.

A continuación, en la siguiente figura, le enseñamos la gestión ágil de proyectos de registro en China, para que pueda comenzar todos los pasos de forma independiente lo antes posible y descubrir la trazabilidad entre ellos.

Instead of process it is useful to have some templates and checklists of critical technical documents which can be acquired by us:

• Device description
• Uso previsto (relacionado con la clasificación)
• Principio esencial
• Shelf life validation
• Archivo de software
• Change assessment in V&V (related to change registration)