Top 10 news of medical device (IVD) in China in 2024

1. Medical device Act

Chinese authority NMPA made a draft of medical device act which will act as first law for medical device (IVD) in China. It replaces “Regulations on the Supervision and Administration of Medical Devices”.

The medical act is more MDR-like in EU with its formulation, length and emphasis but for sure with Chinese elements.

We have following analysis. The speculation will take some years till final publication of medical device act.

11 chapters and 190 articles:

Chapter 1 General Provisions

Chapter 2 Medical Device Standards and Classification

Chapter 3 Medical Device Development

Chapter 4 Medical Device Production

Chapter 5 Medical Device Operation

Chapter 6 Import and Export of Medical Devices

Chapter 7 Use of Medical Devices

Chapter 8 Medical Device Alerts and Recalls

Chapter 9 Supervision and Management

Chapter 10 Legal Liability

Chapter 11 Supplementary Provision

Speculations: 

-The law takes some years till final version

-new chapters: chapter 3 R&D, chapter 6 import and export, chapter 7 usage

-Strength of responsibility of legal representative (=chinese agent)

-Legal representative will be stricter qualified by having manufacturing or distribution licence

-Switch of medical device registration certificate possible

-Accelerate of review of clinical study and preference of multi-centre clinical trial

2. Main stream of medtech in China

In a Guideline for equipment renewal and technological transformation in key industrial sectors by government, for medtech is summarized with goal, policy, standards and main development direction. 

Under main development direction these factors are written:

1. R&D and trial production equipment.

2. Complete machine manufacturing equipment.

3. Key component manufacturing equipment

4. Inspection and testing equipment.

5. Enterprise intelligent management system

6. Industrial operating system

7. Industrial software

3. Medical Equipment Procurement Analysis Report 

There is an analysis report of procurement about country hospital (smaller than city). The power of procurement in Q1 in 2024 is decreased by almost 50%. However these types of product have a better quote than procurement of average products: 

Radiotherapy equipment, surgical equipment and in vitro diagnostic equipment

The domestic products under Radiotherapy equipment is solely under 20% compared to imported products.

In the reports are also details about procurement of 3 tier hospitals, exact procured product and sum of typical medical device with name of manufacturers.

4. Revision of the Classification Catalogue of IVD 

There is Revision of the Classification Catalogue of IVD in China which is valid in 2025. Unlike 3 levels of product code of medical device, IVD has 2 levels, under 1th level 25 main groups, together with 2th level 1852 product code of IVD.

Besides it, we summaries:

• For IVD certificates approved and effective before January 1, 2025, they shall remain valid during the approved validity period.

• Starting from January 1, 2025, for IVD that have applied for registration for the first time, product registration applications shall be accepted in accordance with the Classification Catalogue. 

• For extension registration applications that have been accepted before January 1, 2025, but have not yet been approved, continue to review and approve them in accordance with the original "Classification Catalogue" .

5. Chinese "Good distribution practise" takes effect

NMPA has revised guidance (valid as of July, 2024) of “good distribution practise” (GDP) since first publication in 2014. It applies to all Chinese distributors which are stated on Chinese label.

The details of new guidance are characterised with typical requirements of quality management system as international ISO 13485. 

Besides Chinese GDP there is also a guidance of on-site inspection of medical device business quality management regulations  which is essential to prepare inspection by authority.

Definition of failed inspection:

If the number of items that do not meet the requirements in key requirements is greater than 10% or the number of items that do not meet the requirements in general requirements is greater than 20%, the inspection result will be "failed inspection".

Important articles at GDP:

Article 12: distributor of class II and III medical device should submit an annual quality report by each April

Article 14: make clear about assigned person in charge of the enterprise, person in charge of quality and the quality management personnel

6. Overseas inspection by Chinese authority NMPA in trend

Do you know that Chinese authority approaches overseas inspection at foreign manufacturer now after pandemic break?

We accompanied many inspections especially for manufacturer with his distributor as Chinese agent  lacking regulatory and quality knowledge.

The focus is absolutely at production of approved medical device. The suggestion is to study given plan master file and checklist carefully. It will be asked items by items instead of providing an audit agenda.

See our article with full guidance of overseas inspection

7. Sampling inspection

Every year NMPA issues a list of inspection candidates in China. There are 66 medical devices in 2024. Among notification of inspection, manufacturer of medical device has to confirm sampling inspection, to pay for Chinese labs and to send device to lab in 5 calendar days.

There are three annexes in this year’s notification:

1. National Medical Device Sampling Variety Inspection Plan

2. List of national medical device sampling and re-inspection institutions (Download)

3. National medical device sampling and re-inspection work requirements

So far there are 5 notices  of findings of local and foreign medical devices.

Dec , Oct , Sep ,   Jul , Jul 

8. Usability validation

Finally NMPA issues guidance of usability of medical device. As usual there is unique risk-based must have usability validation of only some high-risk medical device, see the list.

Here some highlights:

· Usability validation of class II and III medical device is obligatory as 08.10.2024.

· Manufacturer has to update usability validation at change registration upon substantial changes to users or usage scenarios or user interfaces

· Under condition overseas usability validation of respective high risk devices could be accepted in China. Difference analysis report on usability engineering requirements between China and foreign countries is needed.

· There is need to mention usability items at Chinese instruction for use.

· For other medical devices (low class II and III) a usability validation or use error assessment report is needed

9. Chinese standards 

There are special Chinese standards dedicated for medical device, abbreviated as YY or YY/T. YY means obligatory. In 2024 there are 90 revised YY standards in China.

We realize that overseas find quite difficult to find applicable standards, then applicable chapters in standards for product registration, followed by good translation in English and gap to higher edition of international standards.

Contact us for support as buying Chinese standards with English translation and gap analysis.

10. Learn Chinese regulation by yourself

It is not an advertisement or that we can not find 10th news in China. We want to encourage all stakeholders interested for Chinese market to actively learn our regulation und understand own product registration. 

There are too many arising regulations in China, however it is besides language rational. Here are some important resources:

Database of approved medical device 

Database of Chinese standard 

CMDE learning online 

Registration workflow 

You can book sessions of our e-Learning to check learn Chinese regulation and global registration if you need our assistance.