Shaanxi food and Drug Administration announced that the medical device registration fee would be reduced from 60000 yuan to 0 yuan

On January 14, the drug administration of Shaanxi Province issued the announcement on adjusting the charging standards for registration of medical and pharmaceutical devices Among them, the requirements for the registration fee of the second category medical device products in China are as follows: According to the legal responsibilities, the drug regulatory department of Shaanxi Province shall carry out administrative acceptance, quality management system verification, technical review and other registration work for the first registration, change registration and renewal registration application of class II medical device products in China, and collect relevant fees according to the standards Registration fee standard for class II medical device products in China: It is understood that the first registration fee in Shaanxi Province is 66521, the change registration fee is 27846, and the renewal registration fee is 27625 Note: 1 The registration fee of medical device products shall be charged according to the registration unit determined in the administrative measures for registration of medical devices and the administrative measures for registration of in vitro diagnostic reagents 2 In the measures for the administration of registration of medical devices and the measures for the administration of registration of in vitro diagnostic reagents, if the application for change of registration items is included, no change registration fee will be charged Medical device product registration fee is an administrative fee item set up by the state for enterprises, which is the fee charged to the applicant when applying for registration of drugs and medical device products At present, the registration of drugs and medical devices is managed at different levels The scope of examination and approval by the provincial drug regulatory authorities includes the supplementary application registration of domestic drugs that do not change the internal quality, the re registration after the expiration of 5 years, the first registration and change registration of the second category of medical devices in China, and the continued registration after the expiration of 5 years As for the formulation of charging standards, for the products registered with the provincial drug regulatory department, the charging standards shall be formulated by the provincial price administrative department together with the financial department Take Beijing for example From May 1, 2019, the registration fee standard of drugs and medical devices in Beijing will be reduced to zero Moreover, the fees collected in advance should be returned to the payer It is emphasized that the above-mentioned administrative and institutional income in arrears in previous years shall be collected continuously and turned over to the state treasury in full After the recovery, the enterprise shall go through the formalities of bill payment and cancellation at the financial department in time The above administrative fees collected in advance will be returned to the payer According to the Beijing News, the reason why the Beijing Municipal Development and Reform Commission changed the registration fee is that in order to implement the relevant policy spirit of tax reduction and fee reduction, actively respond to the opinions and suggestions of some deputies to the two sessions of the Municipal People's Congress in 2019, and further optimize the business environment of the city, it is expected that after the change of the registration fee, the burden of enterprises will be reduced by about 66 million yuan this year The relevant person in charge of SFDA said that after the implementation of the policy, it will be conducive to promoting the innovation and development of pharmaceutical enterprises, promoting the transformation and landing of more sophisticated innovation achievements, and accelerating the transformation and upgrading of Beijing's pharmaceutical and health industry According to the two abolished documents, the original charging standard for medical equipment registration was implemented from July 1, 2017 The first registration fee is 93900 yuan, and the change registration fee is 39300 yuan, which is the provincial unit with the highest national charging standard In addition to Beijing, the provincial units exempt from registration fees are Tianjin and Hubei In addition, in Hunan Province, the same decline is also large, the first registration fee of each variety is reduced by about 20000 yuan compared with the previous; the change registration fee and the renewal registration fee are reduced by nearly 10000 yuan compared with the previous The latest version of the table of class II Registration fees for medical devices in 25 provincial units has been sorted out for readers to consult According to the statistics of the national situation, 25 provinces / cities / autonomous regions have published the class II fee standards so far, 14 regions have reduced the registration fees, with a large reduction range, and some provinces have reduced it by more than 100%.