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
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.
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.
New Fees and Requirements for the Registration of DMFs of APIs in China
On March 2020, the Chinese health authority NMPA increased the registration fee of DMFs for APIs and added new registration requirements.
FDA New Policy on Emergency Use Authorization (EUA) of In Vitro Diagnostics of Coronavirus
On February 2020, FDA issued a Policy that allows CLIA certified high-complexity testing laboratories to use their validated diagnostic tests to detect the SARS-CoV-2 virus in specimen while they are preparing for EUA submission to FDA.
NMPA Emergency Approval of Imported Medical Devices in China: What this means for Foreign Manufacturers
The Coronavirus outbreak in China has led to an extraordinary demand of some medical devices. The NMPA (Chinese health authority) started granting emergency approval to some imported medical device, provided that they meet certain regulatory and quality standards.
China’s Communist Party held a meeting on March 4 to study the current state of Coronavirus in China.
The Standing Committee of the Political Bureau of the Central Committee of the Communist Party of China held a meeting on March 4 which was presided over by General Secretary Xi Jinping to study the current priorities for the prevention and control of the novel coronavirus epidemic and the stabilization of economic and social operations
Accelerated Approval of Detection Reagents of Coronavirus in China
The Emergency Approval of Novel Coronavirus Nucleic Acid Detection Reagent has shown the NMPA accelerated approval of seven NAD Reagents in only four days before going to the market.
China Health Authority CDE Cancelling Face-to-Face Meetings with Companies to Prevent the Spread of Coronavirus
On February 3, 2020 China’s CDE has taken some measures to prevent and limit the spread of corona-virus out from the city of Wuhan.
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.
ONE-TIME IMPORT OF BIOLOGICAL PRODUCTS FOR CLINICAL TRIALS IN CHINA
CDE releases No. 94 of 2018 stating that certain biological products maybe imported for a one- time for clinical trial purposes.