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.
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 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.
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.
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.
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.
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.
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 […]