EU Medical Device Regulation Technical Documentation Structure and Requirements
The main purpose of technical documentation in the EU Medical Device Regulation (MDR) is to prove that a medical device meets the general safety and performance requirements.
Australia’s TGA GMP inspections during COVID-19
During the duration of the COVID-19 pandemic, the TGA will only use remote and hybrid inspections to minimize potential impacts of on-site inspection of GMP clearance.
Anvisa Introduces Pilot Program to Increase Quality of Health Products
Anvisa instituted the Pilot Program to Expand the Quality of the National Health Products Industries, through Ordinance 680/2020. The objective is to strengthen the industries manufacturing health products classes III and IV in the country.
The Medical Device Single Audit Program (MDSAP) has published a new consolidated guidance
On October of 2020, The Medical Device Single Audit Program (MDSAP) has published a new consolidated guidance document called, MDSAP AU P0002.005 Audit Approach.
FDA fills in the details with guidance for Marketing Status Notification
In 2017, the Reauthorization Act (FDARA) made it mandatory for drug marketing holders to notify the FDA about the status of the NDA or ANDA product withdrawal. The FDA releases guidance on how to update the FDA appropriately.
Good Manufacturing Practices Certificate (CBPF) Renewal with Brazil’s Anvisa
Every Two years in Brazil, Manufactures must renew their GMP certificate known as CBPF, incorrect petition of this renewal will lead to rejection or return.
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.
ISO revises guidelines to address the risk management of medical devices
Overview: On December 18 of 2019, The International Organization for Standardization (ISO) presented their new and improved guidelines on medical devices ISO 14971, . The document instructs on the process of risk management for medical devices such as, software as medical devices, in-vitro diagnostic devices and other products which might defer medical devices classification under some […]