China Fast Track Submission options 2022
Three 'Fast-Track' routes
Under the current Chinese regulatory framework for medical device application there are three 'Fast-Track' pathways nationwide available. These so-called green channel paths provide
accelerated approval advantages such as dedicated review and communication platform
with NMPA reviewer, shorter testing and review time, no queuing for
each registration phase, and more supportive guidance.
For innovative products,
the whole registration process is the same as the standard route, however, it will
have a relatively shorter review and approval timeline due to the priority
review. Emergency product review timeline will be significantly reduced to only
10 or 15 days, and the process is also simplified after acceptance to speed up
the market access.
Route 1 Innovative Medical Device (IMD)
The IMD route encourages new technology and promotes industrial development. It is only applicable for the initial registration of class II and class III devices. Eligibility approval shall be granted before the official application. Both the domestic and imported medical device can go through the IMD pathway if it meets the below prerequisites.
Conditions to be met:
- The applicant possesses the core technical patent of the product in China; or the applicant gains the core technical patent of the product via legal transfer procedure; or the application for core technical patent has been published by the China State Council.
- The performance or safety shall have essential improvements compared to similar devices on the global market, the technique shall be advanced and have significant clinical application value when compared to similar devices on the global market.
- The applicant must have completed preliminary study and have a prototype product in place, the research procedure must be authentic and controlled, the research data must be intact and traceable.
The applicant does not need to wait for final patent approval to claim this qualification. If the public notice for verification from the Chinese patent office is received, the IMD application can be submitted. Furthermore, the patent does not have to be originated in China. The licensed usage rights or ownership of the patent is also qualified.
Advantages:
- Early involvement in consultation and guidance
- Dedicated reviewers
- No queuing for each registration phase
- Application fee exemption for small and micro companies (micro companies are those with annual revenue less than 3 million RMB (420,000 USD), and employees < 20 people)
Read more in our blog: Update on the Knows and Dos for innovation pathway.
Flowchart of how the IMD works
Route 2 Priority Evaluation Approval (PEA)
The PEA route accommodates urgent clinical use. The application is made together with the standard registration procedure. If approved, the technical review and quality audit will be automatically prioritized. If not approved, the product continues to be reviewed by the standard process.
Conditions to be met:
- Condition I: medical devices which satisfy one of the following terms:
- Medical devices with obvious clinical advantages used for diagnosis or treatment of rare diseases.
- Medical devices with obvious clinical advantages used for diagnosis or treatment of malignant tumors.
- Medical devices for diagnosis or treatment of diseases which are endemic to and prevalent in the elderly and against which the existent diagnosis or treatment approaches have been ineffective.
- Medical devices with obvious clinical advantages specific for children.
- Medical devices urgently needed, and there is no similar product available in China.
- Condition II: Medical devices are under the national major scientific and technological projects or national vital research and development programs.
- Condition III: Other medical devices subject to priority evaluation and approval.
Advantages:
- Prioritized review and approval with shorter waiting time
- Prioritized quality system audit with shorter waiting time
- Dedicated reviewer to smooth out the process and provide supportive guidance
Flowchart of how the PEA works
Route 3 Emergency Use Approval (EUA)
The EUA route is set up to prevent, control and eliminate the hazards of public health emergencies timely and effectively, and ensure that medical devices required under emergency use can be approved as soon as possible. EUA is initiated when there is a public health emergency or a significant potential for a public health emergency that will impact the national health.
For instance, EUA allowed China to expedite review and approval of diagnostic test kits and equipment to analyze COVID-19 infections in response to the outbreak of coronavirus in early 2020.
NMPA has issued more than 70 emergency approvals, including several diagnostic tests that were approved within five days.
Conditions to be met:
- In the event of a national or regional emergency declared by the State Council or by health authorities.
- No similar products have been approved in China, or the approved product supplies cannot meet the requirements of emergency response.
- Other special circumstances approved by applicable regulatory authority.
Advantages:
- Pre-submission consultation and guidance
- Dedicated reviewers and expert group
- Quality system audit arranged within 2 days
- Type testing within 24 hours
- Fast approval: within 10 days for class II devices and 15 days for class III devices
For foreign applicants, a local Chinese agent or a representative in China shall be appointed to file applications for the three fast-track routes. All the submitted technical dossiers need to be provided in Chinese, and public notarization of English files from the applicant’s location are required if the applicant is located outside of China.