Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Innovative medical device special review

China · National Medical Products Administration · Medical devices

Device: breakthrough or priority programFaster routeHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

4 requirements

Application fee

What is the Innovative medical device special review in China?

Devices with a core Chinese invention patent, a near-final design and a working principle that is first in China, with fundamental improvement and clear clinical value, can enter the innovative product procedure. The agency assigns contacts and offers meetings before and during review. Small and micro companies pay no fee for the first registration. After the product design is basically final.

What are the steps of the Innovative medical device special review?

1. Innovative review application; 2. Expert review; 3. Assigned contacts and meetings; 4. Registration application.

Outcome: Inclusion in the innovative product procedure; registration follows the normal decision.

Legal basis: Measures for the Registration and Filing of Medical Devices (SAMR Order 47), Articles 68 to 72; SAMR Order 48, Articles 67 to 71

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

Official step durations

Steps

In order, with the official target for each step

1. Innovative review application
2. Expert review
3. Assigned contacts and meetingsMeetings are possible before acceptance and during review on major technical, safety and trial design issues.
4. Registration applicationIf the registration is not filed within the set period, the procedure no longer applies.

Requirements

What the applicant must provide or meet

Eligibility

Core invention patent in ChinaThe applicant owns or has use rights to a Chinese invention patent on the core technology, applied within 5 years of grant, or has a published patent application with a novelty search report.
Near-final productEarly research is done and the product design is basically final.
First in China and clinically valuableThe working principle is first in China, performance or safety is fundamentally better, the technology is internationally advanced, and clinical value is significant.

Official time targets

Targets, not actual review times

No time targets published.

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

Other routes in China: Urgent import in the Hainan Boao Lecheng pilot zone, Hong Kong and Macao drugs and devices in the Greater Bay Area, Small-quantity urgent import by hospitals, Expanded access at clinical trial sites, Class I device and IVD filing, Class II device and IVD registration, Class III device and IVD registration, Priority registration for medical devices, Emergency registration of medical devices. See all routes on the China page or explore them in the Regulatory section.

Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.