What it costs to register a drug or device in China

A marketing application for a new drug produced abroad costs RMB 593,900 in registration fees, and first registration of an imported Class III device costs RMB 308,800.¹² The same applications for products made in China cost RMB 432,000 and RMB 153,600.¹² The fee for a drug is due within 15 working days after acceptance, and the review ends if it is unpaid.¹

How the fees are set

The National Development and Reform Commission and the Ministry of Finance issued the governing measures on 12 May 2015.³ A registration fee covers acceptance, review and on-site inspection. For a device, the inspection is the quality management system inspection.³

The national fee is the product of three figures.³

• the rate for one person for one day, which may not exceed RMB 2,400
• the number of staff that registration requires
• the number of working days that registration requires

Fees collected by provincial regulators are set by the provincial price and finance departments, by reference to the measures.³ Four further rules apply.³

• The registration fee excludes the fee for registration testing, which follows separate national rules.
• For an imported product, the regulator adds the travel, accommodation and incidental costs of the part of the inspection carried out abroad.
• The conditions and the fee for expedited handling are left to the national regulator.
• The standards are evaluated in principle every five years and adjusted on the result.

Drug fees

The National Medical Products Administration published the current drug fee standards on 30 June 2020, in force from 1 July 2020.¹

Application	Produced in China	Produced abroad
New drug, clinical trial	RMB 192,000	RMB 376,000
New drug, marketing authorisation	RMB 432,000	RMB 593,900
Generic, marketing authorisation without clinical trials	RMB 183,600	RMB 367,600
Generic, marketing authorisation with clinical trials	RMB 318,000	RMB 502,000
Supplementary application without technical review	RMB 9,600	RMB 9,600
Supplementary application with technical review	RMB 99,600	RMB 283,600
Re-registration, every five years	Set by the province	RMB 227,200

The notes to the table add the following.¹

• One active ingredient or one preparation is charged as one product. Each further strength adds 20 per cent of the fee for its category.
• Changes that are filed or reported carry no fee.
• A one-off import of a drug is charged RMB 2,000.
• The fee for a drug produced abroad includes the difference in travel, accommodation and meal costs for inspection.
• Drugs from Hong Kong, Macao and Taiwan are charged as drugs produced abroad.
• The fee for expedited handling is to be set separately.

Which rate applies

The registration class decides whether the new drug rate or the generic rate applies.¹

Product	Rate
Chemical drugs in Class 1 and Class 2	New drug
Chemical drugs in Class 3, Class 4 and Class 5	Generic
Biological products in every class	New drug
Innovative and improved traditional Chinese medicines	New drug
Other traditional Chinese medicines, including classical formulas	Generic

A generic that needs a clinical trial pays RMB 134,400 for the trial application. It then pays the rate for a marketing application without clinical trials.¹

Payment

The fee is paid within 15 working days after the application is accepted. The date of payment is the date on which the regulator receives the remittance. Where the fee is unpaid, review and approval are terminated.¹

Device fees

The device fees were published by the China Food and Drug Administration on 27 May 2015, in force from publication.²

Application	Made in China	Imported
Class II, first registration	Set by the province	RMB 210,900
Class II, change of registration	Set by the province	RMB 42,000
Class II, renewal every five years	Set by the province	RMB 40,800
Class III, first registration	RMB 153,600	RMB 308,800
Class III, change of registration	RMB 50,400	RMB 50,400
Class III, renewal every five years	RMB 40,800	RMB 40,800
Clinical trial application for a high-risk device	RMB 43,200	RMB 43,200

The fee is charged for each registration unit. Changes that are filed carry no fee. Devices from Hong Kong, Macao and Taiwan are charged as imported devices.²

The implementation rules for devices set a shorter period for payment. The applicant pays within 5 working days of receiving the payment notice. Where it fails to pay, the registration procedure is suspended.²

A fee that has been paid is kept where the applicant withdraws or the regulator refuses the application. A new application pays again.²

Reclassification during review changes the fee.²

• An imported device filed as Class II and found to be Class III leaves the procedure. The applicant files again in the right class and pays the difference.
• A device filed as Class III and found to be Class I or Class II receives a refund. An imported device receives the difference, and a domestic device receives the whole fee.

Exemptions for small and micro enterprises

An enterprise that meets the national definition of a small or micro enterprise pays no new drug registration fee for three kinds of innovative drug.¹

• active ingredients extracted from plants, animals or minerals and unmarketed in China, for HIV or malignant tumours, and the traditional Chinese medicines made from them
• chemical active ingredients made by synthesis or semi-synthesis and unmarketed anywhere, and their preparations
• therapeutic and preventive biological products in registration Class 1

The applicant and the manufacturer must both qualify. The request is made with the registration application and is refused after acceptance.¹

For devices, a small or micro enterprise pays no fee for first registration of an innovative medical device. The device must have been admitted to the special procedure for innovative devices.²

Provincial reductions

A province may lower the fees that its own regulator collects. Shanghai has done so for two years running.⁴

Fee collected by the Shanghai regulator	Level in 2025 and 2026
Registration fees for drugs produced in China	50 per cent of the current standard
Registration fees for domestic Class II devices	35 per cent of the current standard

The current notice runs from 1 January 2026 to 31 December 2026.⁴

Questions people also ask

How much is the registration fee for an imported Class III device?

First registration costs RMB 308,800, a change of registration RMB 50,400 and renewal RMB 40,800.²

Does the registration fee include testing?

The registration fee excludes the fee for registration testing, which follows separate national rules.³

When must a drug registration fee be paid?

It is paid within 15 working days after acceptance. Review and approval are terminated where it is unpaid.¹

Is a fee refunded when an application is withdrawn?

For a device, a fee that has been paid is kept on withdrawal or refusal, and a new application pays again.²

Who sets the fee for a domestic Class II device?

The provincial price and finance departments set it.³²

Footnotes

1. National Medical Products Administration, Drug Registration Fee Standards and Implementation Rules on Drug Registration Fees, Announcement No. 75 of 2020. https://www.ccfdie.org/cn/yjxx/yphzp/webinfo/2020/07/1592159027777795.htm ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰ ↩¹¹

2. China Food and Drug Administration, Announcement No. 53 of 2015 on Registration Fee Standards for Drugs and Medical Devices, Annexes 1 and 3. https://yjj.hebei.gov.cn/directory/web/hbpda/xxgk/zc/qita/20150611231816003.html ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰ ↩¹¹

3. National Development and Reform Commission and Ministry of Finance, Measures for the Administration of Registration Fee Standards for Drugs and Medical Devices, Fa Gai Jia Ge [2015] No. 1006, Articles 3 and 6 to 10. https://www.ndrc.gov.cn/xxgk/zcfb/tz/201506/t20150602_963852.html ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷

4. Shanghai Municipal Development and Reform Commission and Shanghai Municipal Finance Bureau, notice on continuing the temporary reduction of registration fees for domestic drugs and domestic Class II medical devices, Hu Fa Gai Jia Tiao [2025] No. 70, 23 December 2025. https://www.shanghai.gov.cn/gwk/search/content/3416d42a9af1469ea10e140faf142fda ↩ ↩²