Evidence map›Paper›PMID 36262965›Full record

ArticleJournal of orthopaedic translation2022

Advancing medical device regulatory reforms for innovation, translation and industry development in China.

Xu Song, Minxia Hu, Bin Li, Kai Zhang, Xingdong Zhang, Lanming Wang

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of orthopaedic translation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

  1. Review
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  7. Piezoelectric Biomaterial with Advanced Design for Tissue Infection Repair.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025
    Review
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  13. Looking forward to a better 2023 and beyond.Journal of orthopaedic translation · 2022
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Xu SongCollege of Biomedical Engineering, Institute of Medical Device Regulatory Science, and National Engineering Research Center for Biomaterials, Sichuan University, China.
Minxia HuCollege of Foreign Languages and Cultures, Sichuan University, China.
Bin LiOrthopaedic Institute, Department of Orthopaedic Surgery, The First Affiliated Hospital, Suzhou Medical College, Soochow University, Suzhou, China.
Kai ZhangCollege of Biomedical Engineering, Institute of Medical Device Regulatory Science, and National Engineering Research Center for Biomaterials, Sichuan University, China.
Xingdong ZhangCollege of Biomedical Engineering, Institute of Medical Device Regulatory Science, and National Engineering Research Center for Biomaterials, Sichuan University, China.
Lanming WangDepartment of Medical Device Registration, National Medical Products Administration, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The blossoming Chinese medical device market calls for a science-based regulatory system in China. Consistent efforts have been made to advance the medical device regulatory reforms for innovation, translation and industry development. In this article, we report both the latest regulatory requirements which aim to ensure safety and efficacy for patients while encouraging innovation of the medical device industry, and the key programs on medical devices covered in the Regulatory Science Action Plan (RSAP) of the National Medical Products Administration of China (NMPA). The main features of the revised regulations are first elucidated before the opportunities for translational research are interpreted, including those for additive manufacturing and customized devices, drug-device combination products, artificial intelligence-powered software and surgical robots, and nanomaterials for medical devices. Finally, a regulatory perspective is provided to researchers who expect to translate their technologies in the Chinese medical device market. Important issues including early attention to critical market and clinical needs, understanding the true principle and spirit underlying the changing regulations and standards, and protecting intellectual property rights with comprehensive measures, are discussed. These developments warrant further investigations into the distinct role of regulatory science in shaping medical devices research and development.

Indexed as

BiocompatibilityEfficacyMedical devicesRegulatory scienceSafety

Identifiers

PMID36262965
PMCPMC9550533

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.