China Two Fast Track submission routes
Two Fast-Track pilot trial zones
There are also two special regional routes 'fast tracks' to place the product into usage before the standard registration route. In the pilot trial zones, the devices could be used in designated medical institutions to collect clinical trial data, which may be used as clinical evidence for submission purpose.
The two regional routes are the Hainan BoAo Pilot zone approval, and
Guangdong-Hong Kong-Macao Greater Bay Area (GBA) initiative. The regional policy is assisting the manufacturer to launch the products faster on a small scale as a trial, but normally has limitations on product usage in approved medical institutions only or reduced numbers of units. Standard product registration is still required after the trial phase. The details of regional fast routes are described in their dedicated section.
Hainan BoAo Pilot zone approval
In June 2020, Hainan municipal government issued Hainan free trade port Boao Lecheng International Medical Tourism Regulations on the administration of clinical urgently needed imported medical devices in the pilot area (Provision 28).
On January 4, 2021, the National People’s Congress Standing Committee released the draft version of the Hainan Free Trade Port Act, which further clarifies the implementation and administration of devices approved for urgent clinical use.
The key policy of BoAo is that innovative/urgently needed pharmaceutical or medical devices, which are already approved and used in its home market (such as the U.S. and/or the European market), can be used in hospitals in the pilot areas.
The approval process will be governed by the local Hainan provincial MPA with highly integrated efforts from the provincial MPA, the Health Commission, and the Administration office of the Pilot Zone.
The whole procedure may take only 7 working days from application to approval if applied and endorsed by qualified hospitals in Hainan. The data generated in the clinical use there, can be possibly recognized as real-world data, and support the standard product registration approval procedure by NMPA to obtain the import product certificate.
The BoAo pilot provides an option for innovative foreign medical devices to be used in Chinese hospitals on a small scale for validation, before market approval by NMPA.
Guangdong-Hong Kong-Marco Greater Bay Area initiative
On November 25th, 2020, China State Administration for Market Regulation (SAMR) issued an action plan to promote the Development of Innovative Regulatory of Drugs and Medical Devices in the Guangdong-Hong Kong-Macao Greater Bay Area(GBA) of China (Circular [2020]-159) (the "Plan"). Under this plan, the regulator introduces innovative measures to allow eligible medical institutions in GBA to use imported products listed and used in HK and Macau prior to registration with NMPA. On 21st June 2021, Guangdong MPA(GDMPA) issued Provisions on the administration of clinically urgently needed imported drugs and medical devices in the mainland of Guangdong, Hong Kong, and Macao district (Draft). On 19th July 2021, GDMPA issued a consultation version of the expert panel database for evaluation of urgent clinical use. GBA becomes a second option for unapproved foreign devices to be used in China, in addition to the BoAo pathway.
Geographical location: GBA includes 9 mainland China cities in Guangdong province that is Guangzhou, Shenzhen, Zhuhai, Foshan, Huizhou, Dongguan, Zhongshan, Jiangmen, and Zhaoqing.
Application criteria: The devices applied for GBA shall be
1) urgently needed for clinical use,
2) has advanced clinical applications,
3) procured, and already used in HK or Macau public hospitals.
4) The applicant shall be medical institutions originating from HK or Macau as a wholly-owned foreign enterprise, joint venture, or collaboration (technical cooperation or medical consortium) located in the GBA.
The institutions shall have medical practice license, and with appropriate professional departments and teams. With adverse event monitoring system and trained people. University of Hong Kong-Shenzhen Hospital is the 1st designated hospital for a trial, and more medical institutions are encouraged to be included in the initiative. The products/categories to be included in the GBA initiative are catalog-based and change with the market needs. The local Guangdong government will update the catalog from time to time.