Shanghai city opened up the shortage of medical equipment priority approval channel

Pharmaceutical Network December 7 According to "Labor News" reported that the listing declaration process shortened nearly six months.Shanghai to start the medical device examination and approval process optimization and reform since the innovative, livelihood-urgently needed products, the use of 'green channel' system, greatly Accelerate the speed of new products come out.Labourists yesterday learned from the Shanghai Medical Device Industry Association, so far, the city has 26 medical device products have been included in the rapid approval, 4 products successfully obtained registration card.

Some high-risk neonates suffer from congenital malformations such as gastroschisis, leaving gaps in their belly at birth, resulting in some of the intestines being exposed and requiring specialized protective bags to prevent infection, a clinically desperate need for medical devices , But due to the long process of clinical trials and administrative examination and approval process, resulting in the realization of similar inventions really small.Reporter was informed that in rare diseases, geriatric diseases, child disease Areas, there are many similar situations.

Since February this year, Shanghai Food and Drug Administration has implemented the reform and started the implementation of the "Priority Approval Process for Type II Medical Devices". There are no other effective diagnosis or treatment measures for rare diseases, elderly and children with specific or multiple diseases Medical devices urgently needed to be included in the priority approval channel. 'The first two types of medical equipment in the city for the first time registration, renewal of registration, changes in permits, changes in registration and other four review and approval process optimization .Optimization process implementation, the first registration synchronization Application for registration and application system information, simultaneous acceptance of technical review and verification system, clinical trial verification, in the new communication exchange, expert consultation session, focusing on fuzzy and controversial points, timely exchange of information and enhance feedback, especially in the continuation Registration, the compression of nearly 20 working days, greatly improving the efficiency and reduce the duplication of verification. 'City Food Authority medical instruments The Registrar, Raymond Lam, said medical devices that have obvious clinical advantages and are urgently needed in the clinic can be included in the priority approval process.

At present, 26 medical device products in Shanghai have been granted priority approval procedures for innovative medical devices, accounting for nearly one-fifth of the total number of the country. Four of the products have successfully obtained the medical device registration certificate. Not only are the products with the largest number of innovative medical devices in the country Echelon, the growth rate among the best in the country.