Green channel fast approval process for innovative medical devices/ IVDs and prioritized devices/ IVDs

What is the green channel pathway?

It is commonly known that the registration process in China is very long. To promote the technology innovation and fulfill the clinical needs, the NMPA has started the special registration process, so called “Green Channel” for innovative devices since March 2014 and for prioritized devices since January 2017.

What is innovative device?

The NMPA has generated an approval process to identify the “innovative device”.  The prerequisites are follows: 

  1. The applicant shall own the patent or have the right to use the patent in China. The patent authorization shall not be older than 5 years. 
  2. Product prototype is available. The research and development process is authentic and risk-controlled. The research data is complete and traceable. 
  3. The working principle or the mode of action of the product is the first in China. The product shows essentially advanced performance or safety comparing to the predicate, is based on worldwide leading technology and has significant clinical application value.

If the application was approved by the NMPA innovation office, the product is labelled as “innovative device” and can enter the green channel to be registered faster.

The advantages of being labelled as innovative device

The following advantages are available:

  1. Innovative devices are officially published on the NMPA website, which is a huge marketing effect for the product before the market entry. 
  2. The NMPA assigns a reviewer for each innovative device. The applicant can have guidance from the reviewer through the whole registration process.
  3. The lab testing is scheduled faster. 
  4. The NMPA technical review is faster.
  5. For domestic manufactured device, the GMP audit is scheduled faster.

How to apply for being labelled as innovative device?

The applicant shall make sure that the device fulfill the prerequisites listed in the section “What is innovative device?”. 

Please note that home-country approval is not necessary.

The application dossier shall at least include:

  1. Application form
  2. Business license of the manufacturer
  3. Documents and certificates about product intellectual property.
  4. Product research process and results
  5. Product technical data
  6. Information about the product innovation
  7. product risk analysis data
  8. product IFU draft
  9. Other information

The dossier shall be submitted in English (or the home-country office language) and translated into Chinese.

The application shall be submitted to the Office for Innovative Medical Device Review at the NMPA. The reviewing time is 60 working days. The NMPA will then gives a reply whether the product is identified as innovative device or not. If yes, the decision will be published on the website for 10 working days. If no objection is received, the product is then officially identified as innovative device and starts to enter the fast track for registration. 

What is prioritized device?

Prioritized device is defined in another fast-track registration process with prioritized NMPA review since January, 2017.  This fast-track process is mainly focused on the devices to fulfill the urgent clinical needs. 

The prioritized device shall fall into one of the following categories:

  1. Diagnosis or treatment of rare disease with significant clinical advantages
  2. Diagnosis or treatment of malignant tumor with significant clinical advantages
  3. Diagnosis or treatment of specific or common geriatrics diseases, and no other effective diagnosis and treatment available
  4. Use exclusively for children with significant clinical advantages
  5. Devices with national key research plans
  6. Other conditions

How to apply for being labelled as prioritized device?

The applicant shall make sure that the device falls into any of the categories listed in the section “What is prioritized device?”. 

The application dossier shall at least include:

  1. Application form
  2. Application form for product registration
  3. For rare diseases: a. Data about incidence of indications, b. data to show the indication is rare disease, c. State of art for disease treatment, d. data to show significant clinical advantages of the device.
  4. For malignant tumors: a. Data to show the indication is a malignant tumor; b. State of art for disease treatment; c. data to show significant clinical advantages of the device.
  5. For geriatrics diseases: a. Data to show the indication is a geriatrics disease; b.  State of art for disease treatment; c. No other effective diagnosis and treatment available.
  6. For pediatric use: a. Data to show the indication is a pediatric disease; b.  State of art for disease treatment; c. the device is specially used for pediatric disease and shows significant clinical advantages of the device.
  7. Urgent clinical needs without predicates in China: a. State of art for disease treatment and the reason of urgent clinical needs; the registration status outside China of device and its predicates; c. data of search to show no predicates are registered in China and no alternatives available.  

The dossier shall be submitted in English (or the home-country office language) and translated into Chinese.

The submission shall be sent to the Center for Medical Device Evaluation at the NMPA. The CMDE holds montly expert meeting for evaluation. If the review result is positive, the decision will be published for 5 working days. If no objection is received, the product is then identified as prioritized device and enter the fast-track for product registration.

What are the devices successfully entered the fast track?

JMedTec has been monitoring the devices approved as innovative devices and prioritized devices. The detailed device list can be found in our website and updated continuously every month

  1. List of innovative devices approved to enter the green channel registration
  2. List of prioritized devices approved to enter the green channel registration

Why choose JMEDTEC to evaluate the feasibility and assist you with the work of applying for green-channel registration?

JMEDTEC has a professional RA team and keep good communication with the review panel. we have successfully helped a few applicants to enter the green channel. 

We are aware of the challenges of the projects and give you the best advice to present the application dossier for the optimal results.

Please contact us via info@jmedtec.com.