Traceability Matrix at Chinese Registration

Why do you need traceability matrix for Chinese registration of medical device?

The easiest matrix at Chinese registration might be communication matrix in project, order and invoice.

We want to focus on some premium matrix which is for manufacturer time - and budget consuming for success and plays definitely a great role for compliance registration and follow up traced next generation development of medical device (IVD).

We analysis the traceability matrix dedicated for foreign manufacturer who has a bit mind gap due to regulation and language difference.

1. At whole development lifecycle

Key specifications are traced with user requirement, risk management, V&V, product description, Chinese IFU and Chinese testing

Design Change should be related to impact on new change registration, exact Chinese technical documentation, change comparison table, Chinese IFU, part of annual quality management report and overseas manufacturers

2. At registration dossier

Intended use should be consistent in Chinese certificate, Chinese IFU, device description, supporting evidence, clinical evaluation

Key risk requirement should be consistent in specification (and/or symbol and warning text) in Chinese IFU, label, verification and validation

3. At review stage by Chinese authority

Deficiency question should be traced with exact chapter at technical documentation as replay, potential update in Chinese labelling and design history file (perhaps new feature in next product generation)

4. At post market after Chinese approval

One complaint or adverse event case can trigger risk management, reporting in Chinese vigilance, part of annual quality management, periodic risk evaluation report and overseas inspection

One important requirement matrix: product technical document for Chinese type testing

Manufacturer of class II and III has to send device to test in a certified lab in China. As an important document for type testing is product technical documents (PTR). It is very similar to safety, EMC or IEC 62304 etc. report, however will be drafted FIRSTLY by manufacturers with extreme summarised contents (less than 10 pages usually). The special features in PTR are:

• PTR is an input and output for Chinese type testing

• Manufacturers could actively define the specifications to test

• Obligatory Chinese standards require what and how to test 

• Applied standard as method could be Chinese, international or suggested by manufacturer

• Finalised PTR is part of technical documentation to submit to authority and Chinese certificate

• PTR is an important resource for design change after approval

There are 2 important chapters in PTR: chapter 2 performance specifications and chapter 3 method.

Each specification in chapter 2 is to match to a method in chapter 3. This is ignored by overseas manufacturers especially. These requirements should be controlled in the whole lifecycle of medical device, not just for registration.

Here is an example of PTR showing only 2 specifications: (downlod the whole PTR  and see other templates)

2.1 Working conditions

2.1.1 Environmental conditions

The working environment conditions of the product should be clarified, such as: ambient temperature, relative humidity, atmospheric pressure, etc.

2.1.2 Power supply conditions

The power supply voltage, frequency, resistance and power capacity of the product should be specified.

Shall comply with YY / T 0706-2017 of 5.2.1 requires clause.

2.2 Electric power

2.2.1 Maximum output power

The range of maximum output electric power should be specified.

Shall comply with YY / T 0706-2017 of 5.2.1 requires clause.

2.2.2 Nominal output power

The range of nominal output electric power should be specified.

Shall comply with YY / T 0706-2017 of 5.2.2 requires clause.

3. Testing method

3.1 Working conditions

Should meet the requirements of 2.1.

3.2 Electric power

3.2.1 Maximum output power

Press YY / T 0706-2017 the 6.2.1 test method provisions.

3.2.2 Nominal electric power

Press YY / T 0706-2017 the 6.2.2 test method provisions.