European legislation was revised in 2017 to implement Medical Devices Regulation 2017/745
(MDR), and General Safety and Performance Requirements (GSPR) are one of the keystones to establishing conformity with MDR. MDR Annex I lays out three chapters about the GSPR, chapter 1 is the general requirements with risk-based management, chapter 2 is requirements regarding performance, design, and manufacturer, and chapter 3 is requirements regarding labels and IFU (Instructions for Use). Annex II Technical Documentation Section 4 lists out the expected methods/solutions to demonstrate the GSPR conformity. In addition, the Team-NB Position Paper
on Best Practice Guidance of Technical Documentation under the MDR also provides detailed explanations in this regard.
GSPR is not only a European requirement for medical devices but also a general expectation applicable to many other countries such as China, Australia, Brazil, and members of the Association of Southeast Asia (ASEAN). These countries either renamed or partially adopted the fundamental requirements into their own territories with modifications. Today, we focus on its adaption to China.
China follows the International Medical Device Regulators Forum (IMDRF
)’s requirements regarding Essential Principles of Safety and Performance (EPSP) and equally converted its 3rd version for implementation in 2020. In 2022, China published a guidance document on further implementing EPSP and provided a table of content (ToC) template. The ToC contains four columns: the requirements checklist, applicability, methods used to demonstrate the conformity and document’s name/locations to prove the evidence. When comparing the requirements article by article, it is noticed that China EPSP shares the same concept of GSPR and addresses the same issues in principle. Manufacturers shall design and manufacture the medical devices to ensure their safety and effectiveness/performance as intended throughout their life cycle.
When manufacturers prepare the technical documentation to support market approval worldwide, what are the similarities and differences between China and EU (European Union) principles/requirements, and what is the optimal way to leverage the existing documents?Similarities
- The contents are fundamentally similar (90% of the descriptions are more or less the same). Although China uses a table-form checklist, the principles behind it are the same.
- The applicability of the requirements shall be clearly marked out, and an explanation is needed for those which are not applicable.
- The reviewer would expect to see the harmonized mandate national/industry standards or validate/verify solutions as recognized methods.
- A clear indication of the identity/location of evidence in the submitted technical file and the justification for the inapplicable sections are required.
What we may do
- Table checklist is explicitly required by China authority, and format is prescribed, while this is not mandated under MDR.
- Although the Table of Content checklists are similar, the methods and evidence selected to demonstrate the compliance could be varied. Depending on the country-level regulatory system and relevant guidance documents, the evidence demonstration could be China-specific mandate national and industry standards, technical/clinical guidance documents, and test reports. The extra effort to create new evidence shall be considered.
- Certain principles are not addressed in China. For instance, China does not state the substances of concerns (endocrine-disrupting properties) or medicinal substances, or body fluids to be administered to the body. Also, the IFU and label-related sections in GSPR are not applicable either.
- China does not have Common Specifications (CS) and does not require approval by the responsible person (date, signature).
- China does not adopt the NB (Notified Body) guidance document but follows its own Chinese EPSP guidance.
- The identity of the China-specific document and its location may lead to additional work.
For international companies, it is wise to create a uniform checklist in one table/checklist format to document and trace GSPR and reference global requirements with designated columns for each specific country. A mapping tool may also help to match the GSPR and EPSP correlations. If a control list is available, the manufacturer may modify this checklist to adapt to China. Otherwise, GSPR could be revised individually. The China authority expects to receive the EPSP compiled explicitly for China, and the submission language shall be in Chinese.
Qserve helps foreign manufacturers navigate the China EPSP checklist via existing GSPR; to determine similar sections, identify the gaps, and address them to meet the submission requirements.
Please feel free to contact us if you need an English version of the EPSP table checklist or need support to create EPSP.
Want to learn more about Asia-Pacific?
Join us on the 29th of June for a free webinar and Q&A, ‘Medical Device Registration Asia Pacific Part I’.
More blogs from Stephanie Huang on China's regulatory pathway:
Update on the Knows and Dos for innovation pathway
Crucial points to consider when implementing a new version of IEC 60601-1:2012 in China
When a clinical study shall be considered in china