Shanghai pilot medical device registrar system | to speed up the clinical emergency medical device market

Pharmaceutical Net December 8 hearing in Shanghai from the official implementation of the 'medical device registrant system' and pilot pilot in the Free Trade Zone.This will stimulate innovation and vitality of the industry to promote the formation of advanced medical equipment manufacturing cluster in Shanghai to speed up the clinical The urgent need for medical equipment market.This is the reporter learned from the Shanghai Food and Drug Administration news.

In order to implement the national strategy of China (Shanghai) Pilot Free Trade Zone and the Center for Scientific Research and Innovation,health China's strategy and the Municipal Bureau of Food and Drug Administration jointly formulated the Implementation Plan for Pilot Project of Medical Device Registration System in China (Shanghai) Pilot Free Trade Zone in light of the actual situation in this Municipality.

'Medical device registrar system' means that a qualified medical device applicant can apply for a medical device registration certificate separately and then commission a qualified and productive manufacturer to achieve the 'unbundling' of medical device product registration and production license '.

At present, China's medical device implementation of the product registration and production license 'bundled' model must be set up by the registrant factory production, commissioned by the production must be registered and manufacturing enterprises have the medical device registration certificate and production license before they can apply for this. The kind of "bundled" management has affected the enterprise R & D and continuous improvement product quality The responsibility and enthusiasm, limited the rational allocation of innovative elements, inconsistent with the prevailing international rules.

Medical equipment is a multi-disciplinary, knowledge-intensive, capital-intensive high-tech industry.Statistics show that from 2001 to 2016, China's medical device industry innovation Entrepreneurship Highly active, with an average annual compound growth rate of 22.37%, far exceeding the global medical instruments Industry 7% -8% growth.

The Food and Drug Regulatory Bureau of the "pilot implementation plan" to explore medical device product registration and production license separation management mode, hoping to help Shanghai breakthrough land and environmental resources constraints, to promote the medical device industry chain upstream and downstream division of labor and cooperation, Help scientific research personnel, research institutions and innovation enterprise Gather and promote local production of high-end medical equipment.