Comparable to Hainan, Shanghai medical equipment imports are greatly released!

According to Xinhua News Agency, the Shanghai Municipal Committee and the Municipal Government held a further expansion and opening promotion conference held on July 10, and proposed a total of 100 initiatives in five aspects of Shanghai to create a new round of comprehensive new opening. Highlands.

In the medical and medical field, Shanghai should comprehensively promote the construction of import ports for pharmaceutical and medical devices. The opening of some imported medical devices is comparable to that of Hainan Boao Lecheng International Medical Tourism.

Strive for anti-drugs that are urgently needed for clinical use and that have not been approved for registration in China. Tumor New drug, used in Shanghai for fixed use.

For medical equipment that is undergoing clinical trials, for the treatment of serious life-threatening products that are not approved for registration in China, strive to develop in Shanghai.

The pilot reform of the medical device registrant system was extended to the whole city and gradually replicated and implemented in the Yangtze River Delta region.

Cancel the approval of the establishment of large-scale medical equipment for Class B medical institutions, and try to record the system.

Efforts will be made to promote the construction of key laboratories at the national level of Shanghai Pharmaceutical Medical Device Inspection and Testing Organization, and achieve international recognition of test results.

Support and promote flexible entry management mode such as 'one entry, batch clearance', etc. drug Medical equipment clearance efficiency; preparation of international integration of domestic and foreign trade medicine Supply chain platform.

On April 8 this year, the website of the Central People’s Government officially issued the “State Council’s suspension of the implementation of the International Medical Tourism Advance Zone in Boao Lecheng, Hainan. <medical instruments Supervision and Administration Regulations> Decisions on Relevant Provisions (Guo Fa [2018] No. 10).

The "Decision" pointed out that in order to further support the pilot development of international medical tourism-related industries in Hainan Province, the State Council decided to suspend the implementation of the provisions of Article 11, paragraph 2, of the Regulations on the Supervision and Administration of Medical Devices in the Boao Lecheng International Medical Tourism Advance Zone in Hainan. The medical equipment in the medical institution in the first place is urgently needed and there is no medical device approved for registration in China. The Hainan Provincial People's Government implements import approval and is used in designated medical institutions.

It should be pointed out that although the measures in Shanghai and Hainan are different, they have the same effect.

First of all, there are three qualifications for measures in Shanghai. One is clinical trials, and the other is for the treatment of serious life-threatening disease Third, in China, there are no products of the same variety approved for registration. Meet the three qualifications, will be strived to expand use in Shanghai.

Hainan's qualifications include three. One is clinically urgent, the other is that there are no products of the same variety approved for registration in China, and the third is used in designated medical institutions.

Previously, academicians said that the state has strict management of new equipment, new drugs and new consumables. Some drugs, equipment and consumables already used abroad, it takes 3-5 years to settle in the country. After the approval of the State Council policy , Boao Lecheng has a unique advantage in the introduction and use of these drugs, equipment and consumables, as well as the development of new technologies.

Now it seems that this unique advantage will appear in Shanghai at the same time.