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2019-09-06
132 types of medical equipment have been included in the "Import Product List". The import product catalog list has been released. Recently, according to news from the Guangdong Provincial Health and Health Commission, in order to further promote the management of the provincial health and health institutions' government procurement import product catalog list, simplify procedures, and improve the efficiency of government procurement of imported products, after the relevant units submitted their applications independently, the Health and Health Commission organized experts to conduct a unified demonstration and formed the 2019 provincial health and health institutions' import product catalog list. From the content of the list, there are a total of 205 items, including 132 types of medical equipment and 73 types of reagents. The country has very strict requirements for the procurement of imported products.
2019-09-03
China Food and Drug Administration (CFDA) News (Reporter Jiang Hongyu) On August 30, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) issued the "Notice on Adjusting the Delivery Method of Administrative License Documents for Certain Medical Device Application Matters (No. 12, 2019)". The notice shows that from the date of issuance of the notice, for online submissions, the CMDE will no longer mail the administrative license documents at the acceptance stage, including: acceptance notice, payment notice, notice of supplementary application materials, notice of non-acceptance, certificate of change for medical device/in-vitro diagnostic reagent registration matters. Applicant or
2019-09-03
Some medical devices appeared on China's third round of retaliatory tariffs against the US, raising concerns about increased medical costs for ordinary citizens. Industry experts told Xinhua News Agency on the 31st that such concerns are completely unnecessary. In response to the US's further escalation of tariffs, China recently announced a third round of retaliatory tariffs as a countermeasure. Among the items listed in China's second retaliatory tariff list are X-ray computed tomography scanners, color ultrasonic diagnostic instruments, orthopedic or fracture appliances, and endoscopes, which will be subject to an additional 5% or 10% tariff starting from 12:01 on December 15, 2019.
2019-09-02
Licensing Cooperation: Licensing has become a very popular way to introduce products in the pharmaceutical field in recent years. It means that the product introducer obtains the commercial rights to research, development, production, and sales in certain specific countries and regions by paying the product licensor a certain upfront payment, and agreeing on subsequent milestone payments and future sales commissions. The current pharmaceutical industry in China is vastly different from what it was 10 years ago. The biggest difference lies in the shift from channel dominance to product dominance, with "hot products" becoming the focus of market pursuit. This is reflected in the capital market, where the valuation system has shifted from PEG to PEG+Pi
2019-08-30
The medical device industry is one of the important indicators to measure a country's scientific and technological progress and the modernization level of its national economy. Therefore, countries around the world generally attach importance to the strategic position of the development of the medical device industry." When talking about the current development status of China's medical device industry, Fan Xiaodong, vice president of the China Medical Device Industry Association, told a reporter from the Securities Daily. "Currently, China's medical device market is still dominated by low- and mid-range products, and the per capita consumption of medicines and medical devices is only half of the global average, which provides broad development opportunities for technology-innovation-type enterprises." Fan Xiaodong introduced to a reporter from the Securities Daily that China's medical
2019-08-29
According to the National Medical Products Administration (NMPA) website, to implement the "Notice of the General Office of the State Council on Issuing the Reform Plan for the Governance of High-Value Medical Consumables" (Guobanfa [2019] No. 37), standardize the construction of the medical device unique identification system, and strengthen the whole life cycle management of medical devices, in accordance with the "Regulations on the Supervision and Administration of Medical Devices", the NMPA has formulated the "Rules of the Medical Device Unique Identification System", which is hereby released and shall come into effect on October 1, 2019. Article 1 of the Rules of the Medical Device Unique Identification System states that to standardize the construction of the medical device unique identification system and strengthen the whole life cycle management of medical devices, according to the "Regulations on the Supervision and Administration of Medical Devices..."
2019-08-28
Medical Device Quality Spot-Check and Inspection Management Measures (Draft for Comments)
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