Class III (accepted by the NMPA)
Class III initial registration fee: 153,600
Class III variation registration fee: 50,400
Class III renewal registration fee: 40,800 (once every five years)
Clinical trial application fee for high-risk Class III medical devices: 43,200
Class II (accepted by local medical products administrations; Beijing/Guangdong as examples) Beijing Municipal Medical Products Administration Initial registration fee: 93,900 Variation registration fee: 39,300 Renewal registration fee: 40,800 (once every five years)
Guangdong Provincial Medical Products Administration Initial registration fee: 57,200 Variation registration fee: 23,900 Renewal registration fee: 23,800 (once every five years)
What the regulator tells you is only this: registration fees do not include testing fees.
But how much does testing actually cost? In practice, testing bodies charge based on testing capability, the test item list, the number of sample units, and the number of corrective retests required; quotes for the same product can also vary substantially between institutions.
Practical budgeting guidance (common industry ranges for project planning):
Typical ranges (testing body fees only):
Single-use consumables: 30,000–150,000
Active devices (electrical safety + EMC + performance): 100,000–400,000
IVD: 100,000–600,000
If you stop here, you may think registration testing only costs a few hundred thousand.
But the real question is: who pays for the sample units used for testing?
The core factor that truly widens the gap in registration costs:Sample unit cost
A sample unit is not a demo unit; it is treated as the final marketed product,and is a top priority in authenticity verification!
From the perspective of testing bodies and regulators:
sample unit = the medical device intended for market launch
Most testing is destructive or limit testing
After testing is completed, the sample units are essentially scrapped and cannot be sold
| RMB 1 million–3 million+ |
Companies shoulduse theoptimal configuration to build testing prototypes，and ensure prototype authenticity and traceability,while also avoiding duplicate testing.
Clinical Evaluation vs Clinical Trial (determines whether your cost is “hundreds of thousands” or “millions”)
Clinical Evaluation-led (literature/similar-device/equivalence justification + report + deficiency letter responses): commonly RMB 100,000–600,000
If a clinical trial is required (sample size, number of sites, and follow-up duration determine the upper limit): even Class II devices may reach RMB 800,000–2 million+
For ethics review fees, hospital public fee schedules can be used as references: for example, public information from the Affiliated Hospital of Chengdu University shows an initial ethics review fee of RMB 5,000 and RMB 2,000 for amendments.
Therefore,the clinical strategy is the critical starting point。companies should consult the regulatory authorityto determine whether a clinical trial is required and whether a similar-device comparison is acceptable?
Common rework points in Class II registration: incomplete risk management closure, insufficient design verification/validation, inconsistencies between the IFU/performance specifications and verification evidence, and broken change-control traceability.
These issues may not appear on an “invoice,” but they will show up in additional studies, duplicate testing, longer timelines, and sharply increased labor costs.
Especially after receiving the quality system inspection notice and shortly before the review,companies start frantically looking for gaps,patching the storyline,and consuming substantial manpower and resources.Therefore, in routine daily work, companies should maintainstrong quality control,and avoid repetitive rework。This is also a major hidden cost for many companies;many companies spend the finalfew weeks entirely on audit preparation, whereas with good day-to-day quality and compliance practices, there is no need for last-minute scrambling.
Company leaders,registration engineers,after reading this article, do you now have a clearer sense of your device registration costs?Where should the project's priorities be placedto avoidregistration costs doubling？
If you have any questions, please leave a comment for discussion.