Medical Device Market of China

approx. CAGR 20%

Current Medicine — to – MD ratio

CHINA

1: 0.31

World

1: 0.7

China’s MD market remains vibrant with a pronounced increment in terms of the overall market size, considering the Medicine-to-MD ratios is merely 1:0.31, which is still far below the world average know as 1:0.7, indicating the continuous possible spike of China’s MD market growth in the future.

By 2020, China has

X 2.5

larger MD market

compared to that of 2015

1.023 Million

Healthcare Institutions

35,000

Hospitals

9.11 Million beds

in Healthcare Institutions

Policy Overview in China

Note: Due to space limitations,the above map may not be able to display extremely small areas.For the full version of the map,please refer to the official website of the Central People’s Government of the People’s Republic of China (http://www.gov.cn/guoqing/2017-07/28/content_5043915.htm )

Chinese Government takes the initiative to further open the medical device market

Favorable policies with administrative and institutional privileges are implemented in Hainan Free Trade Port and the Greater Bay Area as the pilot areas to further open the market by introducing more advanced medical devices to accelerate the industrial transformation.

LEARN MORE

Link to the official site of NMPA to be well informed by the latest medical device policy and the government stance

The Greater Bay Area

Favorable Policy

Synchronized MD Market Access Mechanism

Regarding the marketed MDs with CE or FDA certification in HK or MO but without NMPA certificate, under the approval of local Guangdong provincial government as the precondition, the designated medical institutions in the Greater Bay Area may procure those mentioned MDs with clinical urgent need and clinical advancement which are currently used in the public hospitals of HK or MO.

Real-world Data Policy

As for the imported medical devices in clinical urgent need, real world data can be used for NMPA registration.

Hainan Free Trade Port

Favorable Policy

Real-world Data Policy [- Imported MDs - ]

Similar to that of the Greater Bay Area, regarding the imported medical devices in clinical urgent need, real world data can be used for NMPA registration as well.

Tariff & Tax Policy [ - JV Domestically Produced MDs - ]

Import tariff can somehow be exempted and tax can be levied in a favorable way when goods produced by the encouraged industrial enterprises enter the mainland China through the “second line”, which indicates the HFTP to other regions.

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F A Q

Is it legal for manufacturers to cope with issues of initial registration without an agent ?

Unfortunately, it is NOT legal unless the manufacturers have branches with qualification in China to deal with the registration issues. Otherwise, it is a must-do that manufacturers overseas are required to appoint a Chinese agent for the medical device registration.

In terms of the initial registration for market entry of mainland China, what is the registration fee needed ?

Regarding the registration fee for NMPA, as for the imported medical devices, the registration of Class II medical device needs 210,900 CNY while that of Class III costs 308,800 CNY. In addition, other kinds of possible fees should be taken into consideration such as fees of document translation, clinical trial, and so forth.

How long is the NMPA review process for the initial registration of the medical device ?

After the registration materials are accepted by NMPA, technical review for Class II medical devices takes 60 working days to process while for Class III medical devices, technical review takes 90 working days. If supplementary materials are required by NMPA, manufacturers are obliged to conduct submission within one year, otherwise the review may result in termination.

Is it possible for a medical device with CE or FDA certificate to enter SAR (HK/MO) and pilot area such as Hainan and the Greater Bay Area ?

MDs with CE or FDA certificate are feasible to enter SAR without NMPA certificate. As for the Greater Bay Area and Hainan province, MDs marketed in HK or MO as a premise can enter the pilot areas if designated medical institutions in pilot areas are willing to procure medical devices out of clinical urgent needs under the approval of local government.