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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
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Posted 16 January 2015 | By Louise Zornoza,
This content is provided by RegLink News, publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members.
China Revises Device GMPs
China’s Food and Drug Administration (CFDA) has issued revised current medical device good manufacturing practices (GMPs) that require manufacturers to implement quality management systems covering product design and development, manufacturing, and sales, including after-sales services.
Manufacturers must also maintain records on product design and development, production, testing, purchasing, sales, and after-sale services. In addition, the quality management system must also cover the operation, cleaning, and maintenance of the manufacturing equipment and facilities.
The revised GMPs take effect 1 March 2015.
CFDA Announcement
China Approves World's First Sabin Strain Inactivated Polio Vaccine
CFDA has announced the marketing approval of the world’s first Sabin strain inactivated polio vaccine. The vaccine was developed independently by China’s Institute of Medical Biology at the Academy of Medical Sciences. The agency acknowledges the assistance of the World Health Organization (WHO), the US Centers for Disease Control (CDC), Japan’s National Institute of Infectious Diseases (NIID), the European Medicines Agency (EMA), and the UK, in the review of the vaccine.
China intends to provide the vaccine to developing countries through the WHO’s polio eradication program.
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