Five projects are at the drafting stage
China’s National Public Service Platform for Standards Information lists five IVD-related national standardization guidance technical document projects registered on October 15, 2026. As checked on October 16, all five were marked as being drafted. The records establish project scope and intended international-standard adoption; they do not constitute publication of the completed Chinese documents or establish new mandatory requirements.
The projects address three distinct areas: supervisors and operators of point-of-care testing (POCT) equipment, IVD manufacturers in a public health emergency, and pre-examination processes for circulating tumour cells (CTCs) in venous whole blood. Their value at this stage is to identify the relevant future texts and, for POCT, the existing document intended to be replaced. Detailed technical changes cannot be inferred from project titles alone.
POCT project would replace the 2023 personnel guidance
Project 20265126-Z-464, Requirements and recommendations for supervisors and operators of point-of-care testing (POCT) equipment, is a revision project with a six-month development period. It identifies ISO/TS 22583:2024 for identical adoption and is intended to replace GB/Z 43281-2023, the existing guidance for POCT equipment supervisors and operators, in full.
Teams that already reference the 2023 document therefore have a specific version relationship to follow. The project title changes from guidance to requirements and recommendations, while retaining the focus on supervisors and operators. That change in wording does not establish which responsibilities, training provisions or competence expectations will be added, removed or revised.
An appropriate preparatory step is to identify where GB/Z 43281-2023 is cited in current training or user-support documentation, so those references can be compared with the revision when its text becomes available. Project registration itself does not mean that the existing document has already been replaced, nor does it establish a change to equipment performance specifications.
CTC projects distinguish RNA, DNA and staining preparation
Three new projects cover pre-examination processes for CTCs in venous whole blood. Each has a ten-month development period and identifies a 2024 part of ISO/TS 7552 for identical adoption.
| Project | Subject | Intended identical adoption |
|---|---|---|
| 20265128-Z-464 | Part 1: Isolated RNA | ISO/TS 7552-1:2024 |
| 20265130-Z-464 | Part 2: Isolated DNA | ISO/TS 7552-2:2024 |
| 20265129-Z-464 | Part 3: Preparations for analytical CTC staining | ISO/TS 7552-3:2024 |
The shared CTC subject should not obscure the different downstream analytical routes. RNA isolation, DNA isolation and preparation for staining need to be matched to the team’s actual examination workflow. The stated scope also matters: these projects concern CTCs in venous whole blood and should not be described as covering all liquid-biopsy applications or all blood-based nucleic-acid tests.
For relevant development and laboratory teams, mapping the projects to their analytical routes is a reasonable initial step. Specific conditions for blood collection, storage, transport or isolation require the actual technical text. The project records do not provide a basis for stating time, temperature or recovery-rate limits.
A separate project addresses public health emergencies
Project 20265127-Z-464, Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency, is a new project with a ten-month development period. It identifies ISO/TS 16766:2024 for identical adoption.
Its focus is IVD manufacturers operating in a public health emergency, rather than POCT personnel or CTC sample processing. Manufacturers involved in emergency product development or supply preparedness may find the future text relevant. Its detailed applicability and considerations still require the published text; the registration record provides no basis for claiming a new emergency approval route or registration exemption.
All five projects are assigned to TC136, with the National Medical Products Administration as the competent authority. The six- and ten-month periods describe project development schedules, not company compliance deadlines. The next substantive milestones are availability of the relevant texts and subsequent formal publication, which would allow a clause-based assessment rather than conclusions drawn from project metadata.
Sources
- Primary official source即时检验（POCT）设备监督员和操作员要求和建议 (opens in a new tab)State Administration for Market Regulation
- Supporting source公共卫生紧急情况下体外诊断医疗器械制造商的注意事项 (opens in a new tab)State Administration for Market Regulation
- Supporting source分子体外诊断检测 静脉全血中循环肿瘤细胞（CTC）的前处理技术规范 第1部分：分离RNA (opens in a new tab)State Administration for Market Regulation
- Supporting source分子体外诊断检验 静脉全血循环肿瘤细胞（CTC）检验前处理过程规范 第3部分：CTC染色分析准备 (opens in a new tab)State Administration for Market Regulation
- Supporting source分子体外诊断检测 静脉全血中循环肿瘤细胞（CTC）的前处理技术规范 第2部分：分离DNA (opens in a new tab)State Administration for Market Regulation