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Control Medical device (et. approved in China) produced not in home country

The constellation of original equipment manufacturer (OEM) and Private label manufacturer (PLM) is challenging in MDR in EU, however exists in most markets, especially in China.

In this article we highlight some views for foreign manufacturer who has approved medical device in China and outsourced production not in own name.

1. Design and development

Legal manufacturer for most cases is owner of medical file or called design history file. For Chinese authority, the legal manufacturer has to roll out Chinese country specific regulatory elements conform to contract manufacturer as specification at “product technical requirement” (PTR), Chinese standards etc.

The specification regulated in China must be 100% produced, controlled and proved at “production inspection” at site of outsourced production.

2. Registration

In chapter 6 of technical documentation for Chinese authority NMPA is typical for production (QM) information not only for legal manufacturer but also for contract manufacturer.

· Chapter 6A Quality Management System Procedures

· Chapter 6B Quality Management System Device Specific information

Upon adding, updating and removing production sites, legal manufacturer should make a change registration updating chapter 6 at submitted dossier.

3. From design transfer to production

The keyword from site of legal manufacturer to outsourced production is “design and inspection control”.

It means the whole device master record should be transferred to contract manufacturer and the inspection report at production must be proved by legal manufacturer in batch manner.

The selection of supplier of components must be released by manufacturer. The contract manufacturer for sure can purchase components himself.

4. Post market and Inspection

Legal manufacturer is liable and responsible for all post market activities after medical device is approved in China.

Legal manufacturer should have regular inspection of contract manufacturer. The scope of inspection should not only be based on ISO 13485 but also compliant to Chinese good manufacturing practise (Nr. 53 in 2022) and related regulation to outsourced production.

At overseas inspection for foreign manufacturer, the contract manufacturer is under strict audit. Normally Chinese auditor would go to outsourced contractor onsite or inspect remotely.

5. Quality agreement

The relationship between legal manufacturer and contract manufacturer is chaotic for domestic manufacturer in China. So China might be only market issues a guidance of Medical Device Manufacturing Quality Agreement mainly for local. It makes monitoring of foreign manufacturer by Chinese authority special that the quality agreement with contract manufacturer is under strict control too.

Here is table of content of Chinese Quality agreement with contract manufacturer according to guidance:

1. Purpose

2. Scope

3. Applicable regulation, standard and technical file

4. Regulatory Compliance

5. Quality management system

6. Management responsibilities

7. Resource management

8. Product realization

9. Measurement, analysis and improvement

10. Change control

11. Intellectual property protection and confidentiality requirements (where applicable)