Working instruction of technical documentation in China

Approval and release

 

	Name	Role/Department	Date	Signature
Initial
Examination
Release

 

Change history

Version	Name	Role/Department	Date	Comments

 

Content

1. Purpose. 3
2. Scope. 3
3. Term.. 3
4. Responsible. 3
5. Applied regulation and document. 3
6. Work flow of Chinese technical documentation. 5
7. Description of each step. 6

1) Start of project. 6

2) Premarket Gap-analysis. 6

3) Preparation of technical documentation. 6

4) Submission of technical documentation. 6

5) Acceptance review.. 6

6) Technical review.. 6

7) Approval 7

 

 

 

1.     Purpose

This process is used to compile technical documentation medical device in China.

2.     Scope

It applies mainly to of class II and III medical device foe which a complex technical documentation is needed in Chinese to be submitted to Chinese authority National Medical Products Administration.

3.     Term

Technical documentation: the submission dossier in China must be written in Chinese and compliant to folder structure to Electronic Regulated Product Submission (eRPS) system.

 

Electronic Regulated Product Submission (eRPS) system is derived from and valid in China in 2019. The submission of technical documentation must be electronic and in given structure of table of content for imported Class II and III – and domestic class III medical devices.

 

Type Testing: is unique Chinese, it is also called in-country test or product/sample test. The device must be sent to a Chinese laboratory according to Chinese standards specifications are tested. For active electrical medical device is typically safety - and electromagnetic compatibility.

 

Product technical requirement (PTR): is a document submitted to test institutes (or Chinese labs) by legal manufacturers. It is a characteristic part of medical device indicating all key performance specifications and test methods derived from Chinese standards whereby the test institutes check own test capability and conduct type test.

 

4.     Responsibility

Regulatory affairs manager is normally responsible for Chinese technical documentation of medical device and process owner.

The involved party could be also internal R&D and external Chinese partner.

5.     Applied regulation and document

Guidance of registration application requirements and approval document format for in vitro diagnostic reagents (NMPA Announcement No. 122 of 2021)

 

Guidance of registration application requirements and approval document format for medical devices (NMPA Announcement No. 121 of 2021)

Guidance of folder structure of the electronic submission catalog (RPS ToC) of the medical device registration electronic submission information system (NMPA Announcement No. 15 of 2021)

6.     Work flow of Chinese technical documentation

Step	Responsible *bold marked is under main responsibility	Task	Output
1	Chinese partner Regulatory affairs manager	Project of type test	Project application
		↓
2	Chinese partner Regulatory affairs manager	Pre-market Gap analysis	Gap analysis report
		↓
3	Chinese partner Regulatory affairs manager R&D	Preparation of technical documentation	Technical documentation V1
		↓
4	Chinese partner	Submission of Chinese technical documentation	Technical documentation V2
		↓
5	Chinese NMPA Chinese partner Regulatory affairs manager R&D	Acceptance review	Revision of applied Technical documentation
		↓
6	Chinese NMPA Chinese partner Regulatory affairs manager R&D	Technical review	Revision of applied Technical documentation
		↓
7	Chinese partner Regulatory affairs manager	Approval	Consolidated Technical documentation (Chinese) Translation of critical Technical documentation into English

 

 

 

7.     Description of each step

1) Start of project

For a project of Chinese registration the basic factors as time, budget, and manpower should be considered in a project application. Normally the project starts with a kick off meeting.

2) Premarket Gap-analysis

To project application it belong also premarket gap analysis as Chinese product code, classification, list of technical documentation, pathway for type testing, clinical evaluation and labelling. The output is a gap analysis report with planned action with timeline.

3) Preparation of technical documentation

With help of Chinese representative (Chinese partner) it starts to transfer English technical documentation in Chinese technical documentation with RPS table of content.

Here are main chapters of technical documentation in Chinese RPS:

• Chapter 1 Regional administration

 

• Chapter 2 Summary Materials

 

• Chapter 3 Non-clinical evidence (see below)

 

• Chapter 4 Clinical evidence

 

• Chapter 5 labelling ad promotional material

 

• Chapter 6A Quality management system procedures

 

• Chapter 6B Quality management system device specific information

4) Submission of technical documentation

When the type testing is completed with testing report and all Chinese technical documentation is compiled, it is time to submit technical documentation with help of Chinese representative to Chinese authority.

5) Acceptance review

Normally in 5 working days there is acceptance screen from Chinese authority whether respective technical documentation is missing with come essential parts which includes sometime also some technical deficiency. Legal manufacturer has no limited time to fulfil the whole technical documentation.

Revision of technical documentation chapter X.Y.Z in deficiency should replace submitted version of technical documentation chapter X.Y.Z.

6) Technical review

In 60 working days for class II medical device and 90 working days for class III medical device after acceptance of Chinese technical documentation there is technical screen from Chinese authority. Legal manufacturer has one year time to reply technical deficiency.

At the same time the approved chapters of technical documentation should be consolidated with new revision of technical documentation chapter X.Y.Z in deficiency replacing former version of technical documentation chapter X.Y.Z.

7) Approval

After approval of subjective medical device, the whole consolidated Chinese technical documentation should be at least translated in English at critical chapter as device description, clinical evaluation and summary of non-clinical evidence.

Ideally the Chinese technical documentation should be matched with former English technical documentation in a matrix.