Clinical Trial Approval for Class III Devices in China

1. Key takeaways

Approval applies to Class III devices listed in a specific catalogue, not to all Class III devices, and the two legal sources governing the deadline are worded differently.

• The object is a listed Class III device, not every Class III device. Under Article 38 of Order 47 (promulgated 26 August 2021, effective 1 October 2021), the catalogue of devices requiring trial approval is set and adjusted by the NMPA.
• The two sources set different deadlines. Article 27 of Decree 739 (State Council Decree No. 739) allows 60 working days from acceptance, while Article 40 of Order 47 allows 60 days. Both remain in force, so scheduling should use the stricter reading.
• Silence is treated as consent. Both provisions treat failure to notify within the period as consent, a procedural consequence that does not remove the Article 38 conditions.
• Sites face a statutory threshold. Article 38 and Article 6 of the GCP (Announcement No. 28 of 2022) require a qualified Grade 3A hospital, and in a multicentre trial every centre must comply.
• Two three-year limits follow approval. Under Article 45 the trial must run within three years, and the licence lapses if no subject signs consent within three years of approval.
• Technical review sits with the CMDE. Article 5 assigns trial applications requiring approval to the Center for Medical Device Evaluation, and the fee is RMB 43,200 for a high-risk device trial application.

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, and the sponsor shall file.
• Article 27: a Class III trial carrying relatively high risk to the human body requires NMPA approval, with a decision within 60 working days of acceptance; silence is deemed consent.
• Article 28: ethics review and informed consent; no trial-related fees from subjects.

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

• Article 5: the CMDE reviews domestic Class III and imported Class II and III applications, and trial applications requiring approval.
• Article 30: testing against the technical requirements; only a passing product may enter a trial or be filed or registered.
• Article 37: site filing and sponsor filing.
• Article 38: listed Class III devices require NMPA approval and conduct in a qualified Grade 3A hospital; the catalogue is set and adjusted by the NMPA.
• Article 39: material requirements for trial applications.
• Article 40: a decision within 60 days of acceptance; silence is deemed consent.
• Article 41: deficiencies notified in full at one time, answered within one year, otherwise review is terminated and approval refused.
• Articles 42 and 43: serious adverse event reporting, and suspension or termination of a trial.
• Article 45: the trial must be conducted within three years of approval, and the licence lapses if no consent is signed within three years.

Normative and technical documents

• Good Clinical Practice for Medical Device Trials (Announcement No. 28 of 2022, published 24 March 2022, effective 1 May 2022): Article 6 requires ethics approval and, for listed products, NMPA approval and conduct in a qualified Grade 3A hospital; Article 66 sets the commencement date.
• Fees: a high-risk device trial application costs RMB 43,200 and a domestic Class III initial registration RMB 153,600.

Practical estimate. No official figure exists for the preparation period before a trial application, the screening and ethics queue for Grade 3A hospitals, or provincial Class II fees. Some provinces publish RMB 40,670 per registration unit; the rate must be verified with the provincial medical products administration and finance department.

3. Expert insights

Sixty working days and sixty days are not the same measure. Article 27 of the regulation uses working days, Article 40 of the order uses calendar days, and the difference is not verbal: a working-day count that crosses public holidays spans more calendar time.

Scheduling should follow 60 working days and include holidays, not 60 calendar days. An over-optimistic schedule leaves sites, ethics, supplies and staff ready while the approval is not.

Deemed consent settles the permit, not the conditions. It is read as permission to start once the period expires, but it settles only whether a decision has been made, not whether the conditions are met. The site grade, ethics approval, both filings under Article 26 and Article 37, and passing testing under Article 30 each remain. The start point runs from acceptance, not submission, so an incomplete file delays acceptance, and correction is bounded by Article 41.

Grade 3A is a statutory threshold, applied to every centre. Article 38 and Article 6 of the GCP use the same wording, and the effect is to turn site selection from an assessment of capability into a test of eligibility. Two deviations recur. The first is reversed order: a site is contracted before the catalogue is checked, and screening restarts when the grade does not fit. The second protects only the lead centre: in a multicentre trial the lead qualifies while others do not, so their data are hard to accept later. A site list should carry grade and qualification evidence, verified centre by centre.

The two three-year limits address different risks. Companies often merge them into one.

The first targets approval without action, the second inability to start, and the second is quieter: site fixed, protocol approved, ethics cleared, yet recruitment never moves, and three years later the licence lapses with the investment sunk. First enrolment should be a separate milestone tracked monthly, with subject availability assessed during protocol design.

Obligations continue after approval. Articles 42 and 43 require serious adverse event reporting and set out suspension and termination, while Chapters 7 and 8 of the GCP add multicentre and record requirements. These duties are trigger-based: an event creates a duty, not the calendar. Without a pre-built mechanism, events go unreported and handling goes unrecorded, which is judged a defect in inspection.

Application material and passing testing constrain the sequence. Article 39 governs trial application material and Article 30 requires a passing test before a trial begins or an application is filed. A test report is a precondition, not an attachment, and an untested prototype or unrepresentative sample under Article 31 invites questions about the data chain.

4. Practical recommendations

• Check the catalogue first, then decide the site range and the approval route.
• Schedule on 60 working days under Article 27 of the regulation, with holidays included.
• Treat the acceptance date as a key milestone, filing complete material at once and planning corrections within one year.
• Verify site grade centre by centre, archiving evidence with the ethics approval.
• Make first enrolment a separate milestone tracked monthly against the Article 45 risk.
• Build trigger-based reporting for serious adverse events and termination into the project SOP.

5. Verification checklist

• □ The product position in the approval catalogue is confirmed (Article 38).
• □ The reviewing body is confirmed as the CMDE (Article 5).
• □ The schedule uses the 60 working day reading, holidays included.
• □ The acceptance date is a milestone, with material filed complete (Article 39).
• □ The response plan follows the one-year limit (Article 41).
• □ Every site is a qualified Grade 3A hospital, verified centre by centre.
• □ Ethics approval is held, and both filings are complete (Article 6; Article 26; Article 37).
• □ Testing has been passed and sample representativeness justified (Articles 30 and 31).
• □ The consent form states that no trial-related fee is charged (Article 28).
• □ First consent is tracked against the three-year line (Article 45).
• □ Reporting and termination triggers are in the SOP (Articles 42 and 43).
• □ The RMB 43,200 fee is calculated against the NMPA 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