The launch of medical device products must accept the supervision of drug regulatory authority in their full lifecycle, and medical device products in Categories II & III are also subjected to the approval of National Medical Products Administration. MGS Life Sci-Tech has professional registrants and teams of senior consultants having many years of working experience, who are richly experienced in the registration of such products as active, passive and in vitro diagnostic devices, life support devices, diagnosis and treatment devices for chronic diseases, is able to provide domestic registration assistance services for medical device enterprises, assist the enterprises in many aspects from writing product technical requirements to product testing, preparation and review of registration materials, application and tracking, application for related qualifications (medical device manufacturer license, medical device operator license), and assist to guide the successful launch of medical device products.
CE certification is compulsory for all medical devices before they’re admitted to EU market. MGS Life Sci-Tech guides the enterprises to establish:
Quality management system in compliance with the relevant EU directives/regulations;
Technical File/Design Dossier of product;（Design Dossier）；
And acts as an agent of the enterprises in certification application and helps them to obtain the qualification for admission to EU market.
The U.S. Food and Drug Administration (FDA) requires all companies and facilities involved in the manufacture and distribution of medical device products intended for use in the United States to undergo establishment registration with the FDA on a yearly basis.
MGS Life Sci-Tech, according to different types of medical device products of enterprises, assists enterprises to complete the procedures of establishment registration and their medical device products with FDA in a one-to-one manner.