Clinical Trial Filing and Site Requirements in China

1. Key takeaways

China runs trial filing on two tracks, and a trial started with only one of them leaves the data without a complete legal basis.

• Filing is dual. Sites are subject to filing management and the sponsor must also file (Article 26 of Decree 739, promulgated 9 February 2021, effective 1 June 2021; Article 37 of Order 47, promulgated 26 August 2021, effective 1 October 2021). The obligations sit with different parties and both are indispensable.
• The current GCP is the 2022 revision: Announcement No. 28 of 2022, published 24 March 2022, effective 1 May 2022, with nine chapters and 66 articles.
• Two statutory gates precede a trial: ethics committee approval (Article 6 of the GCP), and, for products listed in the approval catalogue, NMPA approval plus conduct in a qualified Grade 3A hospital.
• The sponsor is not merely the funder. Under Article 7 of the GCP the sponsor must establish a quality management system covering the whole trial process.
• Passing testing is a precondition. Article 30 of Order 47 requires testing against the technical requirements before a trial.
• Subjects may not be charged. Article 28 of Decree 739 prohibits collecting trial-related fees from subjects.

2. Legal basis

Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 739, promulgated 9 February 2021, effective 1 June 2021)

• Article 25: the two clinical evaluation routes, the second being a clinical trial.
• Article 26: sites are subject to filing management, and the sponsor shall file.
• Article 28: ethics review and informed consent; no trial-related fees from subjects.
• Article 29: expanded access trials.

Provisions for the Administration of Medical Device Registration and Filing (SAMR Order No. 47, promulgated 26 August 2021, effective 1 October 2021)

• Article 30: testing against the technical requirements; a passing product may enter a trial or be filed or registered.
• Article 31: the tested product must be representative.
• Article 36: material required under the trial route.
• Article 37: site filing and sponsor filing.
• Article 38: Class III devices requiring approval must be approved by the NMPA and conducted in qualified Grade 3A hospitals; the catalogue is set and adjusted by the NMPA.
• Article 45: a trial must be conducted within three years of approval, and the licence lapses if no subject signs a consent form within three years of the approval date.

Normative and technical documents

• Good Clinical Practice for Medical Device Trials (Announcement No. 28 of 2022, published 24 March 2022, effective 1 May 2022): nine chapters, 66 articles; Article 3 requires adherence to the Declaration of Helsinki; Article 6 requires ethics approval and, for listed products, NMPA approval and conduct in a qualified Grade 3A hospital; Article 7 requires a quality system covering the whole process.
• Announcement on Inspection Points and Decision Principles for Medical Device Clinical Trial Projects (NMPA, published 2025).
• Fees: a high-risk device trial application costs RMB 43,200 under the NMPA licensing fee catalogue.

Practical estimate. No official figure exists for site screening time, the ethics queue, the multicentre start-up to first-enrolment interval, or provincial Class II fees. Some provinces publish RMB 40,670 per registration unit; the current rate must be verified with the provincial medical products administration and finance department.

3. Expert insights

Dual filing maps to two duty holders. Site and sponsor filing are often treated as one task, yet Article 26 of the regulation and Article 37 of the order assign different content to each.

Confusing them has concrete consequences: the site is filed but the sponsor is not, so the parties are incomplete once the trial starts; or the sponsor files but hands the organising role to a CRO, so the system required by Article 7 never exists. Delegating to a CRO does not transfer responsibility. Execution may be delegated; the system, the oversight and the final responsibility for the data stay with the sponsor.

Site selection adds four conditions together rather than confirming one qualification. The GCP devotes separate chapters to sites and investigators, and the assessment combines four tests: professional match, with a department covering the product field; ethics capacity, with a committee whose cycle fits the schedule; investigator qualification; and facilities and subject resources sufficient for the sample and follow-up. The second and fourth are most often skipped. An ethics cycle out of step with the timetable compresses everything downstream, while weak subject resources push enrolment towards the line in Article 45.

Ethics review and informed consent cannot cover for each other. Article 28 of the regulation states them side by side; Article 6 of the GCP requires ethics approval and Article 3 requires adherence to the Helsinki Declaration. The relationship is often reduced to passing ethics means compliance. Ethics review is an institutional judgment on the protocol and its risk-benefit balance, while consent is an individual protection. When the protocol changes, the consent form must change with it, or records will show subjects signing an outdated version.

For catalogue products the choice of site is narrowed by law. Article 38 of the order and Article 6 of the GCP require NMPA approval and conduct in a qualified Grade 3A hospital, which turns site selection from a capability assessment into a statutory threshold layered on top. Two errors recur: signing with a site before checking the catalogue, then screening again when the grade does not fit; and meeting the requirement only at the lead centre of a multicentre trial, so other centres data are hard to accept.

Multicentre trials buy enrolment speed at the price of consistency risk. The GCP gives multicentre trials their own chapter, and management requirements are no lighter than for a single centre. The main risk is uneven execution: different readings of inclusion criteria, different reporting of deviations, different source data formats. In one centre these can be settled by talking to the investigator; across sites they accumulate. Three tasks belong before kick-off: unified training with assessment records, one deviation reporting route, and one source data template, all documented.

Records form a separate chapter, and gaps cannot be repaired later. The GCP treats records as a chapter in their own right, alongside the protocol and the report. Records are not a by-product but an object with independent compliance status. Correction afterwards does not work: back-filling, back-signing or altering records neither fixes the problem nor avoids creating a new one. The workable approach is to fix the record list and retention duties before start-up and to check periodically. The 2025 inspection announcement gives project inspections an explicit basis.

4. Practical recommendations

• Keep two filing lists, for site and sponsor, each with a named owner and completion date.
• Score sites on the four conditions, setting a minimum for each and excluding any site that fails one.
• Fix the grade before choosing sites for catalogue products; every multicentre site must be Grade 3A.
• Document the sponsor system under Article 7, defining oversight where a CRO is used.
• Complete the three unifications before a multicentre start-up: training records, deviation reporting and source data templates.
• Confirm testing before start-up, with sample representativeness justified under Articles 30 and 31.

5. Verification checklist

• □ Both filings are complete, with responsibilities agreed in writing and CRO oversight defined (Article 26; Article 37).
• □ All four site conditions are assessed and documented.
• □ The approval catalogue position is confirmed; if listed, every site is a Grade 3A hospital.
• □ Ethics approval is held, the consent form matches the protocol and states no trial fee is charged (Article 6; Article 28).
• □ Sponsor quality system documentation is in place (Article 7).
• □ Testing has been passed and sample representativeness justified (Articles 30 and 31).
• □ The three unifications are complete for multicentre work.
• □ Record list and retention duties are fixed, with a monitoring plan (Chapter 8).
• □ First consent is tracked against the three-year line (Article 45).
• □ A self-check against the 2025 inspection points announcement is complete.
• □ The trial application fee of RMB 43,200 is calculated against the current NMPA fee catalogue.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Chinese market. Our team manages NMPA Class II/III registrations and filing procedures, coordinates typetesting, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com