Quality management system

Quo vadis, Chinese Quality management system

Background

One of the country specific regulations is quality management system of medical device. Besides ISO 13485 and MDSAP, almost each market has its own quality management system. In China as well, the production site in China has to fulfil requirements of Chinese quality management system. For the foreign manufacturer with overseas manufacturers there is no obligatory to apply for Chinese GMP however fulfils the requirements to be ready for potential overseas inspection.

Regulation of Chinese quality management system

The Chinese quality management system of medical device is diverse and even more product specific. Below are most important regulations for Chinese quality management system:

YY/T 0287-2017 Medical devices -- Quality management systems -- Requirements for regulatory purpose
Guidance for Medical Device Production Quality Management (order. 64, 2014), Chinese GMP
Medical Device Production Supervision and Management Measures No. 53, 2022
Medical Device Registration Quality Management System Verification Guide No. 50, 2022
Guidance for on-site inspection of medical device production quality management standards
Guidance for on-site inspection of sterile medical devices in medical device production quality management standards
Guidance for on-site inspection of implantable medical devices in medical device production quality management standards
Guidance for on-site inspection of in vitro diagnostic reagents in medical device production quality management standards

Based on first general Chinese GMP guidance, the second one “Medical Device Registration Quality Management System Verification Guide No. 50, 2022” lists each audit requirement as audit task in MDSAP. There are 4 onsite inspections guidances.

There are still many specific supporting guidances depending on types of medical device as:

· Responsibility for quality and safety

· Manufacturing enterprise management representative

· Transportation, storage

· Quality control and finished products

· Cleaning room

Certification of Chinese GMP

Certification of Chinese GMP applies only entities in China where class II and III medical device is produced. The certification body is local authority in province who inspects Chinese entities and issues GMP certification. There is only file system for class I medical device in terms of GMP certification.

A special criterion among application material is approved Chinese certificate and annex PTR which decides the scope and character of inspection.

For foreign manufacturer

For product registration of imported medical device, a valid ISO 13485 of legal manufacturer (including outsourced production) is essential.

After product approval, foreign manufacturer undergoes potential overseas inspection. The applicable guidance is Regulations on Overseas Inspection of Drugs and Medical Devices (2018) No. 101.

Items	China	EU	US
Scope/Regulation	Chinese GMP	ISO 13485, MDR	QMSR, ISO 13485
Certification body	NMPA (central and Province)	Certification body	FDA
Frequency	At the beginning	annually	At the beginning
Validity	5 years	3 years	unlimited
Inspection	Random for overseas inspection Local sampling inspection For-cause inspection due to violation	Random	Random for overseas inspection
Important role	Legal representative, enterprise leader, management representative	Person Responsible for Regulatory Compliance	Lead of QM
Audit time*	1 week	1 week	1 week
Focus	Production, design transfer of critical outsourced partner, and records	Process and records; post-market surveillance	Process and records
Interface to product registration (for foreign manufacturer)	Independent, ISO 13485 sufficient, QM under potential overseas inspection	Both are essential for market access	Independent, QM under potential overseas inspection

*depending company size and product types

Chines GMP certificate is only 5 years valid which needs renewal. There are no annual certification cycles. Upon change, legal manufacturer has to apply a change registration.

Special Chinese GMP-factor

We just focus on difference of GMP of foreign manufacturer.

In China and US, legal manufacturer not in US don’t need have a country specific quality management certification. After approval of medical device, authority could inspect anytime overseas manufacture.

In EU the ISO 13485 is oft linked to MDR certification for EU manufacturer (one inspection for two certificates). Without either of these 2 certificates, even with a valid declaration of conformity of medical device, manufacturers could not place a product in market.

The audit organisation in US and China is authority while in EU is decentralised certification body.

Otherwise the responsible person for quality management in three markets has different names and a bit overlapped function.

Compared 2 overseas inspection in US and China to three-year`s QM certification in EU, the focus of the inspection is diverse although the purpose is the same.

International quality management system