The legislative of medical device is developing in rapid tempo in China. The Regulations on Supervisory Management of Medical Devices have been revised and approved at the 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?
I. Level: Law
“Regulations on supervision and administration of Medical Device” (State Council Order No. 739) has the same legally role as 2017/745 (Medical Device Regulation, MDR) in EU or FD&C Act in US. State Council Order No. 739 is extremely compactly summarized (20k Chinese characters and 107 articles in No. 739 compared to 100k English words and 123 articles in EU MDR) and has only 8 chapters containing registration, manufacturing, after approval sales, adverse event and recall, after approval supervision as inspections and legal liability of medical device.
II. Level: Regulation, NMPA Order
There are many supportive general orders (or provisions) clarifing requirements of product registration, instruction for use, product 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)
Medical Device Production Supervision and Administration Measures (order 53, 2022)
Guidance for Inspection of Quality Management System for Medical Device Registration (order 50, 2022)
Instruction for use and labels of Medical Device (Order 6, 2014)
Adverse Events Monitoring and Reevaluation of Medical Device (Order 1, 2018)
Guidance for compiling annual self-examination report of medical device quality management system (order 13, 2022)
Overseas inspection of Drug and Medical Device (Order 101, 2018)
III. Level: Notification, general guidance
Actually theses guidance issued by CMDE are often useful guideline of product registration.
Clinical evaluation of Medical Device (Order 73, 2021)
Clinical evaluation of IVD (Order 74, 2021)
Approval of overseas clinical trial data of medical device (Order 13, 2018)
Approval of overseas clinical trial data of In vitro diagnostic reagent (Order 95, 2021)
Technical review of medical software (Order 9, 2022)
Technical review of cybersecurity safety of Medical Device (Order 7, 2022)
Product technical requirement (PTR) of Medical Device (Order 9, 2014)
IV. Level: Notification, product-specific guidance
To discriminate to general guidance, there are product-specific guidance matching most product code.
If you have the first 4 digits of product code or general group of interested product, you can search the corresponding product-specific guidance and standards.
3. Chinese Standards of Medical Device and IVD
national (GB) - and industrial (YY) 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 it means obligatory. In general the version of Chinese standards is at developing stage. Most Chinese standards match the oldversion or edition of harmonised international standards. There are three categories compared to international standards: identical (IDT), equivalent (EQV), or non-equivalent (NEQ).
Example
NEW GB 9706.1-2020 (valid as of May, 2026, replacing GB 9706.1-2007)
Corresponding to IEC 60601-1:2012, edition 3, Medical electrical equipment—Part 1: General requirements for safety
NEW YY 9706.102-2021 (valid as of May, 2026, replacing YY 0505-2012)
Corresponding to IEC 60601-1-2:2007, edition 3, Medical electrical equipment－Part 1-2: General requirements for safety－Collateral standards: Electromagnetic compatibility－Requirements and tests
New GB/T 16886.1-2022 (valid as of May, 2023)
Corresponding to ISO 10993-01: 2018, Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
YY/T 0316-2016
Corresponding to ISO 14971:2007, Application of risk management to medical devices
GB/T 25000.51-2016 Systems and software engineering―Systems and software Quality Requirements and Evaluation (SQuaRE)―Part 51:Requirements for quality of Ready to Use Software Product(RUSP) and instructions for testing
Every year NMPA makes a plan of revision or new medical device industrial standards. This means that the applied products must be compliant with new standards in all three types of product registration (initial -, change - and extension registration).
If new obligatory national or industrial standard applies to medical device, very often at least a delta of type testing must be undertaken to fulfill the new requirements. It is similar to an international revision of medical electrical standards as IEC 60601 series for every manufacturers.
Likewise the GB 9706.1-2020 will be prolongated in 2026. As of May, 2026 all medical electrical equipments have to fulfil the new safety requirements at testing and then to be able placed in market. Finally one of the important Chinese standards reaches the international stand of the art.
Read more about predetermined Chinese standards in EP
4. Definition of Medical device in China
Definition
Regulations on the Supervision and Administration of Medical Device (State council order 2021/739)
Article 103
Medical device is an instrument, equipment, appliance, in vitro diagnostic reagent and its calibrator, material, and other similar or relevant articles including necessary computer software, directly or indirectly contacting human body; the effectiveness are obtained mainly through physical means other than pharmacological, immunological or metabolic ways, or such ways are involved in but only play auxiliary roles; which is used to achieve the following intended outcomes:
- Diagnosis, prevention, monitoring, treatment or alleviation of diseases
- Diagnosis, monitoring, treatment, alleviation or functional compensation for an injury
- Examination, substitution, regulation or support of physiological structure or physiological process
- Life support or life sustaining
- Contraception Control
- Examination of the sample from human body to provide information for medical or diagnostic purpose
Medical device registrant and record holder
Article 34
can produce medical devices on their own, or they can entrust enterprises that meet the requirements of these regulations and have corresponding conditions to produce medical devices.
Article 103
refer to the enterprise or research institution that has obtained the medical device registration certificate or handled the record of medical device.
Medical device registrant and record holder refer to marketing authorization holder (MAH) of class I, II and II medical device. It is the same as legal manufacturer which means that MAH has full power of attorney for medical device.
Read basic knowledge before registration of medical device in China Be an expert by understanding key topics
5. Trend of registration at NMPA in 2022
New registered products
Initial registrationare 2500 (+46.2% compared to 2021), change registrations 4224 (+58.5% compared to 2021) and renewals 5281 (-24.8% compared to 2021)
Approved domestic class III medical devices are 5425 and IVD 1287.
Approved imported class III medical devices are 2377 and IVD 302.
Approved domestic class II medical devices are 1590 and IVD 877.
Approved domestic class II medical device are 32889!
Top 5 foreign countries and top product categories
The top 5 foreign countries are US (226+), Germany (117-), Japan (69-), Korea (42+) and France (26, new) which cover 76.4% of total imported medical device and IVD.
Top 5 product categories (total 22 product categories) of domestic medical device:
13 Passive Implantable Devices (400, +68.4%)
03 Neurological and Cardiovascular Surgical Devices (246, +92.2%)
14 Injection, Nursing and Protection Devices (168, +6.3%)
06 Medical Imaging Devices (162, +78%)
01 Active Surgical Devices (113, +76.6%)
Top 5 product groups (total 22 product categories) of imported medical device:
06 Medical Imaging Devices (75, +7%)
13 Passive Implantable Devices (53, +10.4%)
14 Injection, Nursing and Protection Devices (50, new)
17 Dental instruments (45, +9.7%)
03 Neurological and Cardiovascular Surgical Devices (43, +19.4%)
The increase of registrations above is compared to 2021. The reduction of imported medical device is distinct.
In the top 5 product groups from the review of registered number it is not noteworthy about domination of imported product.
Among the common top product groups, 13 Passive Implantable Devices, 03 Neurological and Cardiovascular Surgical Devices, 14 Injection, Nursing and Protection Devices and 06 Medical Imaging Devices have hunge domestic domination.
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