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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
The National Medical Products Administration (NMPA) announces 24 medical device industry standards
2019-07-31
China Quality News Network reported on July 30 that the State Drug Administration's website announced that 24 medical device industry standards, including YY/T0506.8-2019 "Surgical drapes, gowns and clean garments for patients, medical staff and instruments Part 8: Product-specific requirements", have been approved and are now being released. Medical Device Industry Standard Information Table Serial Number Standard Number Standard Name Revision and Replacement Standards Applicable Scope Implementation Date 1 YY/T0506.8-2019 Surgical drapes, gowns and clean garments for patients, medical staff and instruments Part 8: Product-specific requirements Development This standard specifies the requirements for patient, medical staff and instrument
Eight Opportunities and Ten Trends in the Medical Device Industry!!
2019-07-30
With China's further deepening of reform and opening up, social construction, economic construction, and cultural construction have all entered a new development period. Against this broad social backdrop, public demand for medical services is gradually increasing, with the innovation and development of medical devices maintaining a rapid and healthy momentum, and regulatory policies are expected to be further improved. Over the past two years, the author has systematically studied the industry's development. By reviewing the development trajectory and achievements of China's medical device industry over the past 20 years, it is judged that the industry will Enter the fast lane in the next decade. Eight major opportunities and challenges analysis and summary of the current stage of China's medical
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