China Medical Device Registration (NMPA) Guide

The Complete Guide to Medical Device and IVD Registration in China: This page covers the regulatory authority, device classification, registration process, local agent requirements and FAQs for medical device registration in China. Medical devices in China are regulated by the National Medical Products Administration (NMPA), and EVERBIZ can support you through the entire process from classification to certificate.

1. Regulatory Framework Overview

Medical devices in China are regulated by the National Medical Products Administration (NMPA). Whether domestic or imported, products manufactured or sold in China must complete the applicable registration or filing procedure under the current Regulations on the Supervision and Administration of Medical Devices (effective 1 June 2021) before they can be placed on the market.

Tip: The CFDA was renamed the NMPA in the 2018 institutional reform, and all official medical device regulatory documents are now issued in the name of the NMPA.

2. How Are Medical Devices Classified? Three Risk Classes, Three Pathways

The NMPA divides medical devices into three classes from low to high risk, based on the Rules for Classification of Medical Devices (former CFDA Order No. 15) and the Medical Device Classification Catalogue. Notably, on 7 April 2025 the NMPA issued the Rules for Classification of Medical Devices (Revised Draft for Comments) for public consultation from 7 April to 7 May 2025, so the classification rules may become more detailed in future.

Class	Risk level	Market access route	Approving authority	Technical review required?
Class I	Low risk	Product filing	Municipal medical products administration	No
Class II	Moderate risk	Product registration	Provincial medical products administration	Yes
Class III	High risk	Product registration	National Medical Products Administration (NMPA)	Yes

Four key factors for classification (per the Rules for Classification of Medical Devices):

Structural characteristics (active / non-active)
Whether the device contacts the human body
Mode and state of use
Intended use and duration of use

Important: In 2023 the NMPA issued Announcement No. 101, adjusting the classification catalogue for 58 types of medical devices. For affected products already holding a Class II registration certificate, the certificate remains valid until 31 December 2025, and registrants must complete the certificate transition before that date. If your product falls within the scope of the adjustment, please confirm your transition plan as soon as possible.

3. Core Registration Dossier Checklist

Whatever the class, the technical file is the core of the application. Key documents include:

Summary information: product description, intended use, scope of application
Non-clinical data: product technical requirements, test reports, biological evaluation, electrical safety (for active devices)
Clinical evaluation data: clinical evaluation report, clinical trial data (if applicable)
Quality management system documents: compliant with China’s Good Manufacturing Practice for Medical Devices (GMP)
Draft IFU and labeling: compliant with the Provisions for Medical Device Instructions for Use and Labels

About type testing: Class II and Class III medical devices generally require registration testing at a qualified testing institution. In some cases the registrant may perform self-testing, provided it has the required capability and issues a self-test report.

4. Clinical Evaluation: Is a Clinical Trial Required?

Not every product requires a clinical trial. The NMPA provides the following routes:

Exemption from clinical evaluation: products listed in the Catalogue of Medical Devices Exempted from Clinical Evaluation
Clinical evaluation via equivalent devices: completed through comparative analysis with equivalent devices already on the market
Clinical trials: when the above routes do not apply, trials must be conducted at clinical trial institutions filed in China

High-risk Class III implants, life-support devices, etc. generally require clinical trials, and some products require clinical trial approval.

5. Registration Timelines at a Glance

Class	Estimated timeline	Main steps
Class I (filing)	1–3 months	Document preparation → filing
Class II (registration)	12–18 months	Testing → clinical evaluation → technical review → administrative approval
Class III (registration)	18–36 months	Testing → clinical evaluation/trial → technical review → administrative approval

Actual timelines depend heavily on product complexity, number of deficiency rounds and clinical trial progress. Responding to deficiency notices promptly and professionally is key to shortening the timeline.

6. Frequently Asked Questions from Domestic Companies

Q1: We are a domestic company. Can we outsource our registration application?

Yes. Many companies work with professional regulatory consultancies that help prepare technical documentation, liaise with the NMPA and follow up on deficiency requests. This significantly reduces the risk of rejection and speeds up market launch.

Q2: What is the pathway for converting an imported product into domestic production?

In March 2025 the NMPA issued Announcement No. 30, further adjusting and optimizing the requirements for manufacturing imported medical devices in China. Foreign-invested enterprises established by the registrant of an imported device, or under the same actual controller, may manufacture in China the Class II and Class III products for which import registration certificates have been obtained. This is an important policy window for domestic companies to take on localized production for foreign brands.

Q3: What if the classification is uncertain?

You can submit a classification request through the NMPA’s Medical Device Classification Determination Information System. For newly developed devices not yet listed in the Classification Catalogue, applicants may apply directly for Class III registration, or determine the class under the Classification Rules and apply for a classification determination before applying for registration or filing.

Q4: How long is a registration certificate valid? Does it need to be renewed?

Registration certificates are valid for 5 years. A renewal application must be submitted within 6 months before expiry; certificates for which no renewal is filed in time will be cancelled.

Q5: What is required after market launch?

Adverse event monitoring and reporting
Unique Device Identification (UDI) implementation (being rolled out in phases)
Registration changes (when the product, process or scope of application changes)
Unannounced inspections and quality system audits

How EVERBIZ Can Help

EVERBIZ has offices in Shanghai, Hong Kong, Germany, Austria, Singapore, Malaysia, Thailand and Vietnam. For the Chinese market, we offer:

Product classification and registration pathway planning
Preparation and review of registration dossiers, product technical requirements and clinical evaluation documents
Local authorized representative / registration holder arrangements
Submission, responses to deficiency letters and progress tracking
Post-market compliance maintenance (changes, renewals, adverse event reporting)

Contact us for a China medical device registration plan and quote, or see our registration services for other countries and regions.

China Medical Device Registration FAQs

Which authority regulates medical devices in China?

The National Medical Products Administration (NMPA), under the Regulations on the Supervision and Administration of Medical Devices (effective 1 June 2021). Domestic Class I filings are handled by municipal authorities, Class II registrations by provincial authorities, and Class III devices as well as imported Class II and III devices are approved by the NMPA.

How are medical devices classified in China?

From low to high risk into Class I (filing), Class II (registration) and Class III (registration), based on the Rules for Classification of Medical Devices and the Medical Device Classification Catalogue.

Do all medical devices require clinical trials?

No. Some products are listed in the exemption catalogue, or can complete clinical evaluation through comparison with equivalent devices; only products whose safety and effectiveness cannot be demonstrated this way require clinical trials.

How long is a medical device registration certificate valid?

Registration certificates are valid for 5 years, and renewal must be applied for at least 6 months before expiry.