The Health Science Authority (HSA) released a guidance in response to the COVID-19 demand for medical devices like nasopharyngeal swabs, personal protective equipment, face shields and respiratory accessories.
On April 23, 2020, China’s NMPA issued the revised Standard for Quality Control of Drug Clinical Trials (No. 57 of 2020) and will be implemented on July 1.
On April 14, 2020, China NMPA published a new notice to Enhance Quality Inspection for Sterile and Implantable Medical Devices new notice on its new plan to perform random inspections to medical device manufacturers in China
Anvisa’s updated regulation RDC 379/2020 provides requirements for medical device manufactures and identifies devices eligible for priority importation.
On April 9, china’s NMPA announces they will start implementing GB 9706.1:2020 analogous to IEC 60601-1 Edition 2 for electric device manufacturers.
Copyright ©2019 Global Regulatory Partners
