China Registration Fees: Domestic Class III vs Imported Class II/III

1. Key takeaways

China’s registration fees follow a published tariff that measures review effort rather than product risk. The three tiers produce one counter-intuitive result that changes how a pathway comparison should be run.

• The legal basis is Article 120 of the Registration and Filing Measures: fee items and standards follow the finance and pricing authorities under the State Council, executed through the NMPA Catalogue of Administrative Licensing Fees.
• First registration fees form three tiers: domestic Class III CNY 153,600, import Class II CNY 210,900, import Class III CNY 308,800. Import Class III is 2.01 times domestic Class III.
• One ranking is counter-intuitive: import Class II at CNY 210,900 exceeds domestic Class III at CNY 153,600 by CNY 57,300, so a lower class costs more.
• Variation fees rank differently: domestic Class III CNY 50,400, import Class II CNY 42,000, import Class III CNY 50,400. Import Class II is the cheapest to vary.
• Renewal is the only column that is uniform: domestic Class III, import Class II and import Class III all pay CNY 40,800.
• A high-risk clinical trial application is charged separately at CNY 43,200, incurred before acceptance and therefore a preliminary cost.
• Small and micro enterprises filing innovative device applications pay nothing (see article 36).

In our assessment, fees are a small share of most budgets but their structure mirrors where review resources go. Import Class II costing more than domestic Class III shows the tariff prices review complexity, since foreign-language files, notarisation, origin verification and cross-border communication all raise the cost of that tier.

2. Legal basis

Medical Device Supervision and Administration Regulations (State Council Order No. 739, promulgated 9 February 2021, effective 1 June 2021)

• Article 16: domestic Class II is approved provincially and Class III by NMPA; import Class II and III applications go to NMPA through the designated China entity.
• Article 21: substantive changes to a registered product require variation registration; other changes are filed or reported.
• Article 22, paragraph 1: a certificate is valid for 5 years, and renewal must be applied for 6 months before expiry.

Medical Device Registration and Filing Measures (SAMR Order No. 47, promulgated 26 August 2021, effective 1 October 2021)

• Article 5: CMDE reviews domestic Class III, import Class II and import Class III applications, including variations, renewals and trial applications.
• Article 8: Class II is approved and certificated provincially, Class III by NMPA, and import Class II and III by NMPA.
• Article 14, paragraph 2: an overseas applicant or filer shall designate an enterprise legal person within China as agent.
• Article 17: materials shall be in Chinese, with the original supplied where a translation is used.
• Article 120: registration fee items and standards follow the finance and pricing authorities under the State Council.

NMPA Catalogue of Administrative Licensing Fees: sets the fee items and standards for device registration. Also relevant is Announcement No. 30 of 2025 (17 March 2025) on domestic production of imported devices.

Practical estimate. Domestic Class II fees are set provincially and differ; public sources show some provinces charging CNY 40,670 per registration unit for first registration, so verify locally. The amounts here are registration-stage administrative charges, excluding testing, trials, inspection travel, agency services, translation and notarisation, which usually form the larger part of project cost.

3. Expert insights

The full tariff across three stages and three entities.

Amounts in CNY. One direction holds throughout: import Class III is never below domestic Class III. The other two columns cross over, so read cell by cell.

Import Class II at CNY 210,900 exceeding domestic Class III at CNY 153,600 shows what the tariff measures. If risk were the only yardstick, Class III would cost more. Import Class II is higher by CNY 57,300, a factor of 1.37, because the tariff also prices review input.

Class sets review depth; jurisdiction sets complexity. Together they push import Class II above domestic Class III, so do not assume a higher class costs more.

Variation fees do not follow the first-registration ranking. First registration runs import Class III at 308,800, import Class II at 210,900, domestic Class III at 153,600. Variation runs import Class III and domestic Class III at 50,400 each, then import Class II at 42,000, which is CNY 8,400 below import Class III. The gap reflects workload: Class III variations often reopen technical requirements, intended use or clinical evaluation, while import Class II variations are narrower. Holders of import Class II certificates should not downgrade a real variation to a filing to save money; the compliance risk far exceeds CNY 42,000.

Holding cost over five-year cycles, counting first registration plus renewals but excluding variations and trial applications.

Amounts in CNY. Over ten years import Class III spends CNY 155,200 more than domestic Class III, and the same over fifteen, because the gap sits in first registration. One variation adds CNY 50,400 for Class III tiers and CNY 42,000 for import Class II.

4. Practical recommendations

• Budget in two ledgers: administrative fees itemised against the catalogue, and third-party costs for testing, trials, translation, notarisation, agency services and inspection preparation.
• Price both routes, since import and domestic pathways differ in acceptance level under Article 8, agent arrangements under Article 14, paragraph 2, and fee tier.
• Put renewal fees into the long-range budget. At CNY 40,800 across all three tiers, they can be locked cycle by cycle against the 5-year validity under Article 22, paragraph 1.
• Show the trial application fee separately at CNY 43,200 for Class III high-risk products; it falls before acceptance and is not merged with the registration fee.
• Do not downgrade a variation to save fees. At CNY 50,400 for Class III or CNY 42,000 for import Class II, the fee is small against the risk of treating a substantive change as a filing.
• Verify domestic Class II rates with the province, since they are set locally (practical estimate: some provinces at CNY 40,670 per registration unit) and no national figure applies.
• Test the waiver conditions. A small or micro enterprise meeting the innovative device criteria pays nothing; see article 36.
• Model the domestic production switch. Under Announcement No. 30 of 2025, the Class III first registration fee drops from CNY 308,800 to CNY 153,600, against new costs for redrafting technical requirements and retesting.

5. Verification checklist

• □ Figures were checked against the current NMPA fee catalogue, not a historical version.
• □ The tier matches the pathway: domestic Class III 153,600, import Class II 210,900, import Class III 308,800 in CNY for first registration.
• □ Variation fees are calculated by tier: 50,400 / 42,000 / 50,400.
• □ Renewal at CNY 40,800 is in the long-range budget, locked to each 5-year cycle.
• □ The CNY 43,200 trial application fee is listed separately for Class III high-risk devices, before acceptance.
• □ Domestic Class II rates were verified locally (practical estimate: CNY 40,670 per registration unit in some provinces).
• □ Waiver eligibility for small and micro enterprises with innovative devices has been assessed.
• □ Third-party costs sit in a separate ledger.
• □ The domestic production switch is modelled, including technical requirement redrafting and retesting.
• □ Payment receipts are archived and reconciled to the application type.
• □ Article 120 is cited in the project initiation file as the fee basis.
• □ The renewal timetable is logged at 6 months before expiry (Article 22, paragraph 1).

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 acts as the in-China registration agent, coordinates import agent and distributor arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com