Singapore’s HSA Announces Guidance on 3-D Printing on Essential Medical Device for COVID-19
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.
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 .
Singapore’s HSA implements Provisional Authorization Process to Expedite Approval of COVID-19 Diagnostic Tests
Singapore HSA implements provisional authorization process for kits intended to detect and/or diagnosis COVID-19 infection to address the need for COVID-19 diagnostic tests.
China’s NMPA updates standards on quality management system of Drug Clinical Trials
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.
China’s NMPA Random Inspections of COVID-19 Medical Devices Manufacturers
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
Brazil’s Anvisa Updates medical device regulations during COVID-19 pandemic.
Anvisa’s updated regulation RDC 379/2020 provides requirements for medical device manufactures and identifies devices eligible for priority importation.
China’s NMPA Implementation of GB 9706.1:2020
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.
Mexico’s Cofepris releases provision for ventilator requirements during COVID-19 Pandemic.
On April 6, 2020 Mexico’s Cofepris released provisions on the minimum requirements for ventilators to receive approval during the COVID-19 pandemic.
EU Changes IVDR Plan due to COVID-19
The European Union’s new In Vitro Diagnostic Regulations (EU IVDR 2017/746) action is delayed due to COVID-19.
Pharmacovigilance in China
On 2017, China began the harmonization of their pharmacovigilance structure when they joined the ICH. GRP’s blog breaks down the structure of china reporting system and the requirements of a PMF.
China’s NMPA announces the 2020 Medical Device Industry Standard Revision Plan
On March 2020, China’s NMPA issued the 2020 Medical Device Industry Standards Revisions Plan. They revision produced 9 mandatory and 77 recommended standards for Medical Devices.
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