On August 19th, Beijing Innovita Biological Technology Co., Ltd. (“INNOVITA”) obtained the MDSAP certification, which includes the United States, Japan, Brazil, Canada, and Australia, which will help INNOVITA further opened up the international market.
The full name of MDSAP is Medical Device Single Audit Program, which is a single audit program for medical devices. It is a project jointly initiated by members of the International Medical Device Regulatory Forum (IMDRF). The aim is that a qualified third-party audit agency can conduct an audit of medical device manufacturers to meet the different QMS/GMP requirements of participating countries.
The project has been approved by five regulatory agencies, the US Food and Drug Administration, the Canadian Health Agency, the Australian Therapeutic Products Administration, the Brazilian Health Agency and the Japanese Ministry of Health, Labor and Welfare. It is worth mentioning that this certification can replace some of the audits and routine inspections in the above-mentioned countries, and obtain market access, so the certification requirements are relatively high. For example, Health Canada has announced that from January 1, 2019, MDSAP will compulsorily replace CMDCAS as the Canadian medical device access review program.
The acquisition of the MDSAP five-country system certification is not only the high recognition of INNOVITA and its products by Australia, Brazil, Canada, the United States, and Japan, but also helps INNOVITA to continue to expand the overseas registration scale of its new crown testing reagents. At present, INNOVITA’s Covid-19 tests have been registered in nearly 30 countries, including the United States, Brazil, France, Italy, Russia, Spain, Portugal, the Netherlands, Hungary, Austria, Sweden, Singapore, the Philippines, Malaysia, Thailand, Argentina, Ecuador, Colombia, Peru, Chile, Mexico, etc.
It is reported that INNOVITA is still accelerating the application for registration with more countries and institutions, expanding the scale of overseas registration of Covid-19 tests, including applying for EU CE certification (self-test) and US FDA new Covid-19 antigen test kit registration.
The global epidemic continues to spread. INNOVITA’s Covid-19 test kits have been sold to more than 70 countries and regions, and they have conducted accurate, rapid and large-scale investigations for the SARS-CoV-2 virus, playing an important role in the global fight against Covid-19 epidemic.
Post time: Oct-18-2021