July 17, 2018

Pilot medical equipment registrant system now covers the whole city

The Shanghai Free Trade Zone medical equipment registrant system has now been introduced into other parts of the city since it was first adopted in the zone last year. The system allows medical equipment registrants to entrust Shanghai’s medical equipment production companies to produce medical equipment.

Three companies in the city have already obtained the permit, 57 companies have the intent to apply for the qualification, and seven pieces of medical equipment from two companies have passed registration assessment.

Before the system was introduced, the medical equipment registration and production had to be applied by one entity, which dampened the willingness of the medical equipment companies to innovate their research and improve the quality of their products.

Last December, Shanghai Food and Drug Administration issued the Shanghai Free Trade Zone Medical Equipment Registrant Piloting Plan, which allows qualified medical equipment applicant to apply for the medical equipment registration and then entrust qualified companies with the production of the equipment, facilitating the innovation of medical equipment.

MicroPort’s portable electrocardiography monitor was the first beneficiary of the new system, which cut down the time-to-market by one year, saving the company 1 million yuan (US$ 149,367) in production cost.

Benefited by the system, Medtronic Inc entrusted Jabil to produce operation power systems, reducing the product production chain and their production costs.

With the expansion of the system across the city, it will help medical equipment companies to restructure themselves and to form aggregation effects and facilitate the optimized resource allocation.