Design control and Product release of medical device in China

Product release of medical device is not a special keyword at ISO 13485 and plays a great role at Chinese GMP in China. It belongs to design control. It has close interface with design & development and even product registration (related to product technical requirement).

There are three important inspections in term s of design control and product release at production of medical device.

Incoming inspection

The incoming inspection procedures should at least clearly specify the name, specification, model, verification/confirmation/monitoring/measurement/inspection/test items and methods, applicable instruments and equipment, sampling procedures, sampling plans, acceptance criteria, reference standards/reference measurement procedures and related records of the purchased items.

In-process inspection

The in-process inspection procedures should at least clearly state the name, specifications and model of the intermediate products, verification/confirmation/monitoring/measurement/inspection/test items and methods, applicable instruments and equipment, sampling procedures, sampling plans, acceptance criteria, referenced standards/referenced measurement procedures and related records.

It applies also to critical production step intern or extern (sterilisation) and software system validation.

Final inspection

The final inspection procedures for finished products should at least clearly state the name, specifications and model, verification/confirmation/monitoring/measurement/inspection/test items and methods, applicable instruments and equipment, sampling procedures, sampling plans, acceptance criteria, referenced standards/referenced measurement procedures and related records of the finished products.

There should be a document matching final inspection items with PTR at product registration. If the specifications are not covered at production, a rational must be formulated. We strongly recommend all specifications at PTR are verifiable either at production or at design and development.

Contact us to have a control of production record compliant to Chinese GMP even the medical device is produced not in China. It is an important part at overseas inspection and at product registration to show production test (3 inspections).