Non-stop regulatory news in China and globe

Non-stop regulatory news in China and globe of medical device (IVD) in 2024

Non-stop regulatory news of medical device in China and gloabe

We try to list all useful regulations of medical device in China and global here. If you don’t want to miss any news, book our newsletter. Due to the length we update only legislative of subject year 2024. Check our news in 2023, 2022, 2021 and 2020 in Chinnese market.

Usually for Chinese product specific guidance and standards, you could book our payed requirement radar to not miss any wished regulation related to your product group.

Here some highlights in product specific guidance:

Scope (product code with description)
Key points of registration review

device description
product technical requirement
risk management with typical hazards
biocompatibility
sterilization
raw material control
shelf life, packaging
clinical evaluation and study,
labelling
New: usability
New: quality management document

If you want to have solid education of global regulatory affairs of medical device, visit our one year academy with personal coach and test cases. Contact us for a free consulting.

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Trend of medical device in China

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

Be prepared with us. We can support your inpection as regulatory and quality expert in Europe.

See similar article, post approval activities in China

2. We see that more and more manufacturer struggles to catch testing during the deficiency stage at registration of medical device by authority. Testing is time - and budget consuming. Verification and validation is a great part of development and registration.

We have development a tool with our Partner Matrix Requirement. You can trace testing requirement for typical type testing of medical device in China.

Book free consulting and demo

News of medical device in China

Overview

There is a summary report in term of Chinese registration of medical device and IVD by authority. Some interesting info are:

Number of imported medical device
Top 5 imported product groups

Quality management

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, pay for Chinese labs and send device to lab in 5 calendar days.

See our summarised three annexes of this 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

In first annex you can find applied product group, inspection items, standards and whether re-inspection is allowed.

If whether re-inspection is not allowed, the sampling should come from reserved medical device during serial (lot) production.

Among testing items, inspection items, standards are key parts of product technical requirements (PTR) for type testing.

· Full translation of three annexes and notification

· have automatic control of inspection items and standards

· have a mock audit manufacturing sites in and outside China

· Inspect Chinese distributor

· support preparation of potential sampling inspection

Registration

1. Clinical evaluation and clinical trial

Can you believe that Chinese authority has a risk-based of clinical evidence of all product groups (22 main groups)?

After a full list of 3 types of clinical evidence (simplified clinical evaluation, complex clinical evaluation and clinical trial) in 2022, NMPA has revised the list of 25 group of medical device in 2024 (download).

#the complex clinical evaluation is very similar to European clinical evaluation (MDR), with more emphasis of equivalent comparison.

In this list in includes: 6 digit product code, device description, intended use, example and choice of 3 types of clinical evaluation.

How to use this collection?

For experienced manufacturer in China: you should check the updated clinical pathway in China and adjust next product generation upon the given clinical pathways.

For new manufacturer in China: you should have a gap analysis of clinical pathway. It can be tough to find equivalent data if second pathway (complex clinical evaluation) applies.

2. 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 (download).

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

Contact us to have a gap analysis. For US manufacturer it is no trouble to his professional usability validation. It might be a new hurdle for manufacturers in other markets even in Europe to pass this validation.

News of medical device global

We try to summerise most critical regulatory news here in free basis which impacts product registration.

For a detailed regulatory radar you can contact us to book your markets.

FDA makes Final Rule Amending the Quality System Regulation. See the amendments.

Canada has a draft guidanc e in term of "significant change". Study the beautiful 10 changes types, it is good example for change assessment in global market.

Taiwan authority has a unique collection of all important regulation and notification of medical device in a 235-page PDF.

[Medical Device Management Act]

[Implementation Rules of the Medical Device Management Act]

[Measures for the Classification and Grading Management of Medical Equipment]

[Measures for the Management of Medical Equipment Technicians]

[Measures for the establishment and management of source and flow data of medical equipment]

[Medical device manufacturers set standards]

[Medical Device Quality Management System Guidelines]

[Measures for Inspection of Medical Device Quality Management System and Issuance of Manufacturing License]

[Criteria for Contracted Manufacturing of Medical Devices]

[Good Shipping and Marketing Guidelines for Medical Devices]

[Measures for the inspection and issuance of quality transportation and sales licenses for medical devices]

[Criteria for issuance and registration of medical device licenses and annual declaration]

[Methods for approved manufacturing and import of specific medical equipment projects]

[Measures for the Management of Excellent Clinical Trials of Medical Devices]

[Measures for the Safety Surveillance and Management of Medical Equipment]

[Measures for Notifying Serious Adverse Events of Medical Devices]

[Measures for border random inspection and inspection of imported medical equipment]

[Methods for recycling and disposal of medical equipment]

[Medical equipment administrative fee charging standards]

[Measures for the appointment or entrustment of medical device inspection]

[Measures for the Management of Certification and Entrusted Certification of Medical Equipment Inspection Agencies]

[Measures for the entrustment of medical device management matters and the certification of entrusted institutions]

[Incentive Measures for Medical Equipment Innovation and Technology Research and Development]

[Medical device dealers (pharmacies) that set up separate medical device vending machines are exempt from applying for separate business premises sales business licenses]

[The scope and types of medical equipment retail business that pharmacies may concurrently engage in]

[Items of medical equipment sold through communication trading channels and matters that should be followed]

[Types of medical equipment sold by vending machines and matters that should be followed when selling them]

[Medical equipment for which source and flow data should be established and maintained, and medical equipment items for which source and flow data should be reported]

[Items exempt from obtaining medical device manufacturing license]

[Article 24 of the Medical Device Management Act: Medical device items and their sellers who should establish an excellent distribution and sales system for medical devices]

[Medical device items that should obtain marketing authorization through login]

[Specifications, inspection methods and performance that specific medical equipment items should comply with]

[Medical device labels, instructions or packaging are exempt from the manufacturing date, validity period, or shelf life requirements]

[Warnings and precautions should be included on labels, instructions or packaging of specific medical devices]

[In accordance with the provisions of Article 25, Paragraph 4 of the Medical Device Management Act, the central competent authority shall directly register and cancel the original license, and relevant provisions on product labels, instructions or packaging]

[Requirements that medical device labels should carry a single identification code]

[Matters that should be added to medical equipment items and their labels or packaging that require electronic instructions to replace Chinese instructions]

[Clinical trial format of medical devices without significant risks]

[Except for daily wear daily disposable contact lenses, advertisements for other contact lenses must be published in medical publications, communication tools exclusively for medical personnel, or medical academic related activities exclusively for medical personnel to participate]

[Medical equipment items that should be subject to safety surveillance]

[Those who use medical equipment to collect, process or utilize personal information shall replace written consent]

a. MDR transition

Do you follow the policy of MDR transition extension in Australian government? It is worthy to have a plan of MDD products for European manufacturer.

b. Leverage of existing certificte

1. UK recognises international approval of medical device in some markets:

AustraliaTherapeutic Goods Administration (TGA)
Canada Health Canada
European Union (EU) National competent authorities in the member states of the EU/ European Economic Area (EEA)
United States of America (USA) Food and Drug Administration (FDA)

see our post in linkedin.

2. The similar draft of leveraging regulatory authorisation (IN 290/2024) occurs in Brazil too.

c. IMDRF published new