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2019-08-09
Clinically, a large number of mid-to-high-end medical devices have been localized, gradually replacing imports, with a significant price advantage. Jiang Deyuan, a drug inspector from the Medical Device Registration Office of the National Medical Products Administration, stated at a press conference held by the State Council Information Office on the 1st that China's medical device industry is developing rapidly, with a large number of mid-to-high-end medical devices having achieved domestic production, gradually replacing imported products. Product quality is generally recognized by patients, and the Price is also more advantageous than imported products. Jiang Deyuan stated that in recent years, the National Medical Products Administration has taken a series of measures to promote the innovative development of the medical device industry. In 2014, China began to implement innovation
2019-08-08
Unique Device Identification (UDI) is like an electronic ID card for medical devices. In the information age, UDI is an advanced method for international medical device regulation and a "universal language" for global traceability of medical devices. In recent years, the national drug regulatory authorities have actively promoted the application of UDI in the field of medical devices in China, and on December 20, 2018, issued the medical device industry standard "Basic Requirements for Unique Identification of Medical Devices", which will be implemented from January 1, 2020. Currently, some companies have already...
2019-08-07
This newspaper reports (Reporter Zhao Peng) that from drug production licenses to GMP certificates for drugs, relevant enterprises will be able to submit fewer supporting documents in the future when handling related matters. Yesterday, a reporter learned that the National Medical Products Administration (NMPA) issued an "Announcement on Canceling 16 Proof Items," deciding to cancel some proof items for the second time this year, following the initial cancellation of 36 proof items in April. The reporter noted that the 16 proof items canceled this time by the NMPA cover drugs, pharmaceutical products, medical devices, and special cosmetics. Among them, 3 cosmetic proof items have been changed to online verification, and 9 drug proof items have been changed to internal verification.
Overview of the Medical Device Industry Development
2019-08-06
In recent years, the market size of China's medical device industry has continued to grow. From 2010 to 2015, the global medical device market size increased from US$326 billion in 2010 to US$371 billion in 2015. Below is an analysis of the development of the medical device industry. In 2016, the total market size of China's pharmaceutical market was approximately 14,774 billion yuan, with a consumption ratio of pharmaceuticals to medical devices of 1:0.25. The global consumption ratio of pharmaceuticals to medical devices is approximately 1:0.70, while developed countries such as the US, Europe, and Japan have reached 1:1.02. From international experience, the future of China's medical device market
2019-08-02
According to a press release from the National Medical Products Administration (NMPA) on August 1, to thoroughly implement the spirit of the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council's "Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices" (Hall No. [2017] 42), accelerate the innovative development of the medical device industry, and based on the previous pilot work of the medical device registration system in the Shanghai, Guangdong, and Tianjin Free Trade Zones, today, the NMPA (hereinafter referred to as the "National Bureau") issued the "Notice on Expanding the Pilot Program of the Medical Device Registration System" (Guo Yaojian Xie Zhu [2019] 33, hereinafter referred to as the "Notice"), further...
2019-08-02
The State Council Information Office held a regular press conference on the State Council's policies at 3 p.m. on Thursday, August 1, 2019. Li Tao, Vice Minister of the National Healthcare Security Administration, and heads of relevant departments introduced the relevant situation of the reform plan for the governance of high-value medical consumables and answered reporters' questions. 【China Daily reporter】May I ask, what is the current situation of the domestic production of high-value medical consumables? What measures will the National Medical Products Administration take in the future to further improve the domestic production of high-value medical consumables? 【Jiang Deyuan, Drug Inspection Commissioner, Medical Device Registration Management Department, National Medical Products Administration】Regarding the domestic production and accessibility of high-value medical consumables, it is a systematic project,
2019-08-01
On the one hand, each cardiac stent costs tens of thousands of yuan, with imported products being even more expensive; on the other hand, leading experts in cardiology point out that 12% of patients in China have undergone excessive treatment, and 38% of stents are considered "optional". Some of the problems encountered in the use of cardiac stents are merely a microcosm of the various drawbacks in the field of high-value medical consumables. Therefore, calls for rectifying this field have been continuous. On July 31, the General Office of the State Council issued the "Notice on Issuing the Reform Plan for the Governance of High-Value Medical Consumables" (hereinafter referred to as the Notice), clearly proposing to lower the inflated prices of high-value medical consumables and to Cancel public
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