China is the only one of the ten busiest countries in our data where early device study registrations rose sharply, but the work is mostly domestic. This guide covers how a first-in-human (FIH) or early feasibility study (EFS) is regulated there, what the registry shows, and what that means for a United States (US) sponsor weighing China against Latin America.
What the registry shows
Our query of ClinicalTrials.gov (CT.gov) found 108 early-stage, industry-sponsored device studies with at least one site in China, first posted between 1 January 2021 and 28 September 2026. That ranks China #7 worldwide on this measure. Of these, 49 used FIH, feasibility or pilot language in the title or summary, and 22 explicitly described a first-in-human or early feasibility study. 17 were run by sponsors headquartered outside China, 11 of them by US-headquartered companies, and 3 also listed sites in another country. Registrations went from 47 in 2021–2023 to 61 from January 2024 to September 2026. Sponsor headquarters could not be resolved for 11 studies, so the home-country count is a floor.
Method: bioaccess® analysis of the ClinicalTrials.gov (CT.gov) application programming interface (API) v2, run 28 September 2026: industry-sponsored interventional device studies first posted 1 January 2021 to 28 September 2026 (6,045). Early-stage means FIH, early feasibility, feasibility or pilot wording, or phase N/A with 50 or fewer planned participants (2,968 worldwide). Sponsor headquarters were inferred for 95% of studies. Counts are registrations, not approvals, and recent years are under-counted.
How device trials are regulated in China
Device trials in China follow the Provisions for Medical Device Registration and Filing (State Administration for Market Regulation (SAMR) Decree No. 47, effective 1 October 2021), administered by the National Medical Products Administration (NMPA).
- Filed sites and good clinical practice: trials must follow device good clinical practice (GCP) at qualified institutions that have filed with the authorities, and each trial is filed with the provincial regulator (Art. 37).
- High-risk class III devices: devices on NMPA’s catalogue need NMPA approval before the trial and must be studied in top-tier (tertiary grade A) hospitals (Art. 38). NMPA decides within 60 days of accepting the application, and the result is published through its Center for Medical Device Evaluation (CMDE). If NMPA does not respond in time, the trial counts as approved (Art. 40).
- Overseas companies need a legal agent in China (Art. 14).
- Human genetic resources (HGR): under China’s 2019 HGR regulations, foreign entities may not collect or store Chinese human genetic resources themselves or send them abroad. Work involving such material needs Chinese partners, the relevant approvals or filings, and ethics review. Plan for this if your study collects biological samples.
Where China is strong
- Growth: the only sharp rise in registrations among the ten countries with the most studies (about +42% annualized).
- FIH volume: 22 of 108 studies were explicitly FIH or EFS, more than any European country we profiled.
- Cardiovascular scale: Cardiovascular (63 studies), oncology (15) and neurology (10) led the mix, and cardiovascular alone made up more than half.
Using data from China in a US submission
The US Food and Drug Administration (FDA) can accept device data from outside the United States under the Code of Federal Regulations (CFR) at 21 CFR 812.28 if the study follows good clinical practice (GCP), including independent ethics review and informed consent, the sponsor supplies the required supporting information, and FDA can validate the data, if needed by inspection. The rule covers studies begun on or after 21 February 2019. FDA recognizes the International Organization for Standardization (ISO) device GCP standard, ISO 14155:2020; check the recognition status of the 2026 edition before you plan to it. Meeting 812.28 is not clearance or approval, and FDA may still ask for US data. Confirm your plan through a pre-submission under FDA’s Q-Submission (Q-Sub) program.
How Latin America compares
China’s early device work is overwhelmingly domestic (80 of 108 studies had Chinese-headquartered sponsors), and China is 12 hours ahead of US Eastern during US daylight saving time and 13 otherwise. Across the 15 Latin American countries we track, the same query found 132 early-stage device studies in total. 38 of them were explicitly FIH or EFS, which is 12% of the 310 such studies worldwide, and 102 (77%) had US-headquartered sponsors. The region is used mainly for US companies’ first human data.
- Time zone: Panama stays on UTC−5 (Coordinated Universal Time minus five) all year, the same as US Eastern Standard Time.
- Regulation: each Latin American country has its own national pathway. We don’t quote a single clock; country planning ranges come with each proposal.
- Ethics: bioaccess® publishes a 4–8 week median planning range for ethics review in its lead countries. This is based on our experience, not a formal study, and it is not a guarantee.
- Cost: we don’t publish per-patient figures. Compare line-item budgets, including monitoring travel and translation.
- Where we work: bioaccess® has focused on FIH studies since 2010. We lead execution in Panama, El Salvador, Chile and the Dominican Republic, with 50+ pre-qualified sites across 19 countries.
When China is the better fit: if the Chinese market is your first commercial target, you have a Chinese partner and legal agent, and your data plan fits the HGR rules. For a US company whose first goal is FDA, Latin America offers a US-aligned time zone and a long record with US sponsors.
Frequently asked questions
Does a first-in-human device trial in China need NMPA approval?
High-risk class III devices on NMPA’s catalogue need NMPA approval, decided within 60 days of acceptance, and must be studied in tertiary grade A hospitals. Other trials are filed with the provincial regulator and run at filed, qualified institutions under GCP.
Can a foreign company run a device trial in China directly?
Overseas companies need a legal agent in China. Under the 2019 human genetic resources regulations, foreign entities also may not collect or store Chinese human genetic resources themselves or send them abroad.
Can data from a Chinese first-in-human study support an FDA submission?
It can, if the study meets 21 CFR 812.28 and FDA can validate the data, including by inspection. Sample-export limits under China’s HGR rules may affect what can be verified outside China. Acceptance is not clearance or approval.
How does China compare with Latin America for a US sponsor’s first-in-human study?
China has volume and growth, mostly for domestic sponsors, 12–13 hours from US Eastern. Latin American sites work mainly with US sponsors, and Panama keeps US Eastern Standard Time all year.
Next step
Weighing China against Latin America for an FIH or EFS study? Book a call with Julio Martinez-Clark to review your device class, endpoints and FDA plan.
Sources
- NMPA, Provisions for Medical Device Registration and Filing (SAMR Decree No. 47), English text
- State Council, Regulations on the Administration of Human Genetic Resources (2019), Chinese text
- State Council, Regulations on management of human genetic resources (English summary)
- 21 CFR 812.28, Acceptance of data from clinical investigations conducted outside the United States (eCFR)
- FDA, Acceptance of Data from Clinical Investigations for Medical Devices
- FDA Recognized Consensus Standards database, ISO 14155:2020 (recognition no. 2-282)
- FDA, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- ClinicalTrials.gov API v2 (query run 28 Sep 2026; filter in Method note)
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