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Essential principle of safety and performance

Essential principle of safety and performance of medical device in China, EU and global

Chinese essential principle of safety and performance

Background of essential principle of safety and performance of medical device


The first essential principle of safety and performance was initiated by IMDRF in 2005.

In China, the first essential principle of safety and performance (Chinese EP) of medical device was issued in 2014, followed by revision in 2020 (medical device with IVD together) and in 2021 (separate EP for medical device and IVD). The regulatory thread in new revision is to guarantee essential principle of safety and performance of medical device in entire life cycle. The main changes of Chinese EP are


·        the control of the production and packaging of sterilized medical devices for users

·        software requirements for integration with mobile computing platforms, network security requirements

·        permits to provide labels and instructions through electronic means


Besides the typical requirements as stipulated by IMDRF, Chinese EP conforms with standard “Application of Medical Device Risk Management to Medical Devices" (YY/T 0316-2016) and the quality management process at design and development must be controlled to identify the relevant risks applicable to the product and take corresponding risks control measures to form technical documents such as design input, design output, design verification, design confirmation, risk management report.


This is a great part of Chinese GMP for domestic manufacturers reflected in Chinese EP. For overseas manufacturers, these requirements are coved by providing ISO 13485 certificate.


Regulations on the Supervision and Administration of Medical Devices, 2021/739


*The term “safety and effectiveness” of medical device at Regulations on the Supervision and Administration of Medical Devices (2021) has the same meaning of essential principle of safety and performance.


Article 17 The drug regulatory authority that accepts registration applications shall review the safety and effectiveness of medical devices, as well as the registration applicant's ability to ensure the safety and effective quality management of medical devices.


The date of acceptance of the application for registration of the drug regulatory departments shall accept registration application within 3 working days to apply for registration information was transmitted within the technical review mechanism. The technical review agency shall, after completing the technical review, submit the review comments to the drug regulatory authority that accepts the registration application as the basis for review and approval.


When the drug regulatory department that accepts the registration application considers it necessary to verify the quality management system when organizing the technical review of the medical device, it shall organize the quality management system verification



Comparison of essential principle of safety and performance of medical device in China to EU and International Medical Device Regulators Forum (IMDRF)


In new guidance in 2022, the template for essential principle of safety and performance was revised into 2 main parts:

A. General principles of safety and performance

B. Basic principles applicable to medical devices.


As one of the overall submission document it bears the focus of authority of reviewing the whole technical documentation of medical device.


The Chinese EP is located in chapter CH 3.3 at electronic regulated product submission format.

Let us compare Chinese essential principle of safety and performance to general safety and performance requirement (GSPR) at annex I at MDR in Europe briefly.


Chinese essential requirement of safety and performance in chapter CH 3.3 General safety and performance requirement at MDR
A1 (A1.1-A1.9) General requirement General requirement 1-9
A2 Clinical evaluation und clinical study -
A3 Chemical, physical and biological properties 10 Chemical, physical and biological properties
A4 Sterilization and microbial contamination 11 Infection and microbial contamination
A5 Environment and conditions of use 14 Construction of devices and interaction with their environment
A6 Protection against electrical, mechanical and thermal risks 20 Protection against mechanical and thermal risks
A7 Active medical equipment and medical equipment connected to it 18 Active devices and devices connected to them
A8 Medical devices containing software and standalone software 17 Electronic programmable systems
A9 Medical devices with diagnostic or measurement functions 15 Devices with a diagnostic or measuring function
A10 Instructions for use and labels 23 Label and instruction for use
A11 Radioprotection 16 Protection against radiation
A 12 Protection against use risks for non-professional users 22 Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons
A13 Medical devices containing biological materials 13 Devices incorporating materials of biological origin
B1 Chemical, physical and biological properties 10 Chemical, physical and biological properties
B2 Radioprotection 16 Protection against radiation
B3 Special requirements for implanted medical devices 19 Particular requirements for active implantable devices
B4 Risk protection of medical devices that provide energy or substances to patients or users 21 Protection against the risks posed to the patients or user by devices supplying energy or substances
B5 Combination products containing pharmaceutical ingredients 12. Devices incorporating a substance considered to be a medicinal product and devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body.
Read more about tracing Chinese registration (essential requirement)

How different is Chinese EP compared to MDRs GSPR and international EP for medical device?


Chinese EP of medical device
EP of medical device at IMDRF
GSPR in MDR


Chinese EP contents A2 clinical evaluation and clinical study while it is not descripted in European GSPR at MDR. A10 Instructions and labels in Chinese EP refer to Chinese IFU and label.


The requirements in both markets regarding software are weakly described without details. It leaves many space for manufacturer to fill evidence in EP, however definitely not to avoid a t technical dossier. In general, the Chinese EP derived from recently published regulation is almost 1:1 same as European GSPR. OF course the sub-items at European GSPR are more in details.


As in GSPR in EU by filling Chinese EP you should add evidence documents which will be examined by NMPA at formal registration and might be proved at inspection in two different columns.


Special in Chinese EP, manufacturers should/must chose product specific guidances besides Chinese standard. By the way there are no humanised standards which might make only sense in Europe.


At least from the new issued template of Chinese EP, the disadvantage is unclear Chinese standards without year and even without Chinese name. The manufacturers should not just select standards and guidances listed in template. It could be rational, if templated will be extended with additional column explaining partly and not applicable requirements.  


Example of filling essential principle of safety and performance in China


There are following items to fill in Chinese EP-table: methods used to prove compliance and documents that provide objective evidence of compliance and documents that provide objective evidence of compliance at submission dossier and not included at registration (e.g. in QM).


For methods used to prove compliance, the items below can be selected:

  • (1) Published regulations and normative documents of the medical device department.
  • (2) Relevant national standards, industry standards, and international standards for medical devices.
  • (3) Generally accepted test methods.
  • (4) Company's self-determined method.
  • (5) Comparison with similar products that have been approved for marketing.
  • (6) Clinical evaluation

 

For documents that provide objective evidence of compliance, the documents name with eRPS chapter CHX, Y, Z should be given. If no technical documents at dossier were provided, the name of QMS-document with reference should be filled.


Outlook

The new template (July, 2022) of essential principle of safety and performance of medical device has revised without big challenge for manufacturers and there are other requirments at new Chinese EP than in Chinese eRPS guidance.



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Contact us to have new issued Chinese essential principle of safety and performance in 2022. We support to fill the EP and match to registration dossier und quality documents. Ultimately you have extracted applicable Chinese standards and guidance to monitor.


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  • International and Chinese standards matching Chinese essential principle of safety and performance
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  • Automatic trace of standards and action items of new technical documentation


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Essential pricinple in China versus GSPR in MDR

Related link of Essential Principles of Safety and Performance


IMDRF, Regulated Essential Principles of Safety and Performance

MDR, Checklist of general safety and performance requirements

Australia, Medical devices Essential Principles checklist

Malaysia, ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE 

Brazil, Provides for the essential safety and performance requirements applicable to medical devices and in vitro diagnostic (IVD) medical devices, RDC No. 848, new in 2024


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