Session 1.1 Knowing Chinese authority

1.  Learning objective

In this session without knowledge of Chinese language, you should learn the legislatie under NMPA and how to self-navigate website of Chinese authority.

2. Video

3. Knowing Chinese authority

a. Structure of Chinese legislative

The legislative of medical device is developing in sportive tempo in China. The Regulations on Supervisory Management of Medical Devices have been revised and approved at the 119th Executive Meeting of the State Council end of 2020 and is valid on 01.06.2021. Since then diverse provisions, notifications and technical guidances are published which should be comply with and followed in the whole life cycle of medical device marked in China. How does legislative of medical device in China build up?

2. Level: Regulation, NMPA Order

There are many supportive general orders (or provisions) clarifying requirements of product registration, instruction for use, classification, adverse event and overseas inspection of medical device. 

Medical Device Registration and Filing Management Measures (order 47, 2021)

IVD Registration and Filing Management Measures (order 48, 2021)

3. Level: Notification, general Guidance

It is translated as notification. Actually theses guidances issued by CMDE are useful as guideline of product registration.

Clinical evaluation of Medical Device (Order 73, 2021) 

Clinical evaluation of IVD (Order 74, 2021)

4. Level, Notification, product specific guidance

To discriminate to general guidance there are product specific guidances matching most product codes.

Chinese Standards

There are two kinds of Chinese standards: national (GB) issued by the Standardization Administration of China (SAC), and industrial (YY) issued by NMPA. The non-binding or recommended character has prefix /T. Without /T (GB and YY) it means obligatory. In general the version of Chinese standards is at developing stage. Most Chinese standards match the old version of harmonised international standards. There are three categories comparing international standards: identical (IDT), equivalent (EQV), or non-equivalent (NEQ).

• “regulatory dynamic”: info of approved products
• “announcement notices”, “regulatory documents” and “policy interpretation: about regulation, it should be monitored
• “flight inspection”, “medical device recalls”: data of post market surveillance
• “medical device popularization”: popular science
• “medical device inquiry”: database of approved products
• “medical device unique identification”: UDI

c. CMDE website

Go to website https://www.cmde.org.cn/index.html

1) There are another resources under 法规文件 (=regulatory)

2) Registration work flow

You can find many valuable info and regulation.

·        Pre-submission consultation

·        Medical device classification

·        Testing

·        Clinical evaluation

·        Innovative medical device review and emergency review

·        Acceptance registration application

·        Priority evaluation and approval processes

·        Supplementary

·        Expert consultation meeting

·        Consultation after supplementary

·        Rejected registration and initiative revocation of registration application

·        Issuing of certificates

·        Changes to registration

·        Renewal

·        Notification instruction for use changes

·        Others

3) Evaluation work flow by authroity

There are explanations of each review time point after submission of dossier

·        Intelligent allocation

·        Filing examination

·        Special review for innovative medical devices

·        Emergency product technical evaluation

·        Priority approval

·        Simple project

·        Complex review project

·        Clinical trial approval

·        Expert consultation

·        Pre-review

·        Group decision

·        Recheck

·        Issue

·        Formal check

4) Chinese registration database

It is the same database which can be found in NMPA and CMDE website.

If the link dosent work, click 医疗器械产品查询 middle right.

Then you can use different filters to search approved products. For overseas products click “imported medical device” (filing for class I medical device) and registration for class II and III medical device)

4. Test

In professional mode of E-Learning participants will get one to one coach to navigate website of Chinese authority in customer need.

* at black week you can send us the answer of tests below via E-mail and get free gifts.