China’s NMPA Addresses Common Period Risk Evaluation Report (PRER) Issues
China’s NMPA updates and address some common issues faced by the Marketing Authorization Holders to submit PRER report.
Face Mask Regulations by Australia’s TGA
Non-sterile face masks are regulated as medical devices under the Therapeutic Goods Act of 1989. Importation, distribution or exportation of any goods are required to be included in the ARTG (Australian Register of Therapeutic Goods).
FDA introduces Medical Device User Fee Amendments for Fiscal year 2021
Food and Drug Administration updates lists of Medical Device User Fees for Fiscal year 2021. and increases cost of certain MD submissions.
FDA holds up UDI enforcement for Class I device
The FDA delays the enforcement of Unique Device Identification (UDI) for Class I medical devices and will come in action from 24 September 2022.
China’s CMDE releases new procedure for medical device registration
China’s Center for Medical Device Evaluation (CMDE) released 2 announcement revising medical device registration procedures.
FDA Updates Medical Device Establishments Inspection Processes and Standards
FDA released a final guidance on inspections of medical device establishments requiring reviewing processes and standards applicable to inspections of domestic and foreign device establishments
China’s NMPA issues Guideline for changes of Raw Material in Passive Medical Device Products.( No. 33 2020)
China’s NMPA issued a guidance (No 33. 2020) on May 19, 2020 to provide a guideline and systematic approach for risk analysis of raw material changes in passive medical device products .
Global Regulatory Partners is Joining the Fight Against Coronavirus (COVID-19)
Global Regulatory Partners is Supporting the Fight Against Coronavirus (COVID-19) -Contact US to Learn More
ANVISA NEW REGULATION FOR POST-APPROVAL CHANGES TO MEDICAL DEVICES: RDC 340/2020
On March 3, 2020, Anvisa published a new regulation “RDC 340/2020” that classifies the changes made to approved medical devices in Brazil, into three categories based on the level of risk .
NMPA PUBLISHES NEW GUIDELINE ON HOW TO ADDRESS LETTER OF DEFICIENCIES FOR MEDICAL DEVICE COMPANIES IN CHINA
On January 16, 2020 the NMPA publishes guideline explaining how medical device manufacturers should respond to a letter of deficiency from NPMA.