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

Priority registration for medical devices

China · National Medical Products Administration · Medical devices

Priority or accelerated reviewFaster routeHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

3 requirements

Application fee

What is the Priority registration for medical devices in China?

Devices for rare diseases or cancer with a clear clinical advantage, devices for diseases of older people without effective options, devices made for children, urgently needed devices with no similar registered product, and devices from national key research programs can ask for priority registration. Review and quality system inspection are scheduled first. At the registration application.

What are the steps of the Priority registration for medical devices?

1. Priority request with the registration application; 2. Eligibility check; 3. Priority review and inspection.

Outcome: Priority review and inspection.

Legal basis: Measures for the Registration and Filing of Medical Devices (SAMR Order 47), Articles 73 to 75; SAMR Order 48, Articles 72 to 74

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. Priority request with the registration application
2. Eligibility check
3. Priority review and inspection

Requirements

What the applicant must provide or meet

Eligibility

Clinical need cases(in some cases)Rare diseases or cancer with a clear clinical advantage, diseases of older people without effective options, devices only for children with a clear advantage, or urgent needs with no similar registered product.
National research programs(in some cases)Devices in national major science projects or national key research programs.

Other

Provincial class II programs(in some cases)Provinces may set their own special procedures for class II devices.

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, Innovative medical device special review, 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 (6 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.