How many drugs and devices China approved in 2025

In 2025 the National Medical Products Administration approved 14,187 medical device registrations, of which 3,402 were first registrations.¹ The Center for Drug Evaluation completed 19,375 drug registration applications, and 76 Class 1 innovative drugs were approved.²

The two series count different things. Device and drug applications are counted one by one, and most of them are renewals and changes. Innovative drugs are counted by product.¹²

Medical devices

The national regulator handles domestic Class III devices and imported devices of Class II and Class III. It accepted 14,647 applications in 2025, 5.9 per cent more than in 2024. It approved 14,187, which is 8 per cent more.¹

Approved in 2025	Number	Share
First registration	3,402	24 per cent
Renewal	5,056	35.6 per cent
Change of registration	5,729	40.4 per cent

In vitro diagnostic reagents made up 3,566 of the approvals, or 25.1 per cent.¹ Companies withdrew first applications or cancelled certificates of their own accord in 331 cases.¹

By origin and class

	Approved	First registrations
Domestic Class III	8,147	2,760
Imported Class II	3,102	270
Imported Class III	2,938	372

Imported devices came to 6,040 approvals in all.¹ First registrations were 8.7 per cent of imported Class II approvals and 12.7 per cent of imported Class III approvals. The rest were renewals and changes.¹

Where imported devices come from

Products from 30 countries and regions were approved in 2025. The United States, Germany, South Korea, Japan and France led in first registrations of imported devices. Together they accounted for about 75.4 per cent of them.¹

Enterprises in 19 provinces acted as agents for imported devices. Agents in Shanghai represented the largest number of first imported devices, at 62.1 per cent of the total.¹

Jiangsu, Guangdong, Beijing, Shanghai and Zhejiang led in first registrations of domestic Class III devices, with 65.1 per cent of them.¹

Innovative devices

The regulator approved 76 innovative medical devices in 2025, which is 16.9 per cent more than in 2024.¹

Innovative devices	2024	2025
Applications for the special review procedure	451	457
Approved in the year	65	76
Approved since 2014	315	391

Of the 457 applications in 2025, 104 were admitted to the procedure.¹ Of the 391 approved since 2014, 336 are domestic and 55 are imported. The imported devices come from 30 enterprises in 6 countries.¹³

Filings

Class I devices are filed and are outside the approval count. The national regulator handled 1,826 filings of imported Class I devices in 2025. Municipal regulators handled 21,574 filings of domestic Class I devices.¹ The national regulator also handled 6,415 filings of changes.¹

Compared with 2024

	2024	2025
Applications accepted	13,828	14,647
Registrations approved	13,133	14,187
First registrations approved	3,363	3,402

Checks on clinical trials

The report for 2024 records 1,498 clinical trial institutions on file at the end of that year. Provincial regulators carried out 885 inspections of institutions, 55.5 per cent more than the year before. The inspections covered 59.1 per cent of the institutions on file.³

The national regulator checked 50 products under review in two rounds, through on-site inspection of trials and verification that the product was genuine. That was 66 per cent more than in 2023.³

Drugs

The Center for Drug Evaluation published its report for 2025 on 13 May 2026. Applications are counted by acceptance number.²

Drug applications in 2025	Accepted	Completed
All registration applications	20,149	19,375
Change on 2024	3.00 per cent more	6.11 per cent more
Clinical trial applications	3,756	3,773
New drug applications	663	562

Of the applications accepted, 18,448 concerned drug preparations, and 16,130 of those required technical review.² Applications for traditional Chinese medicines came to 2,723.² Completed clinical trial applications rose by 16.96 per cent and completed new drug applications by 28.02 per cent.²

Approvals by product

Approved in 2025	Products	Through priority review
Class 1 innovative drugs	76	26
Rare disease drugs	48	12
Paediatric drugs	138	25
Drugs marketed abroad and unmarketed in China	80

Of the 76 innovative drugs, 11 have a new mechanism or a new target. Fifteen were approved conditionally, and 15 had been admitted to the breakthrough therapy procedure during their trials.²

The count of rare disease drugs leaves out Class 4 generic chemical drugs.² The paediatric count includes 98 marketing applications and 40 products whose indications were extended to children.² Of the 80 drugs marketed abroad, 57 were approved for the first time and 23 gained an indication.²

Questions people also ask

How many medical devices did China approve in 2025?

The national regulator approved 14,187 registrations, of which 3,402 were first registrations. The rest were renewals and changes.¹

How many imported devices were registered for the first time?

First registrations came to 270 for imported Class II devices and 372 for imported Class III devices.¹

How many innovative drugs were approved in 2025?

The regulator approved 76 Class 1 innovative drugs, of which 11 have a new mechanism or a new target.²

Which countries register the most devices in China?

The United States, Germany, South Korea, Japan and France led in first registrations of imported devices in 2025.¹

Do the device figures include Class II devices made in China?

The national figures cover domestic Class III devices and imported Class II and Class III devices.¹

Footnotes

1. National Medical Products Administration, Annual Report on Medical Device Registration for 2025, published February 2026. ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰ ↩¹¹ ↩¹² ↩¹³ ↩¹⁴ ↩¹⁵ ↩¹⁶ ↩¹⁷ ↩¹⁸ ↩¹⁹

2. Center for Drug Evaluation of the National Medical Products Administration, Annual Report on Drug Evaluation for 2025, published 13 May 2026, as reported by China Food and Drug News. ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰ ↩¹¹

3. National Medical Products Administration, Annual Report on Medical Device Registration for 2024, published February 2025. https://www.ccfdie.org/zryyxxw/zxdt/webinfo/2025/02/1732618537692923.htm ↩ ↩² ↩³