Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 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.
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.