Module 19: Regulation of In Vitro Diagnostic Medical Devices

20/04/2023

The big regulated markets -Brazil

 Regulator is ANVISA  IVDs are regulated as IVD medical devices ● Four risk classifications I,II and III and IV  Class I/II use Cadastro registration route low risk submission  Class III/IV use the Registro route and require GMP inspection of site (Changing to MDSAP process)  Brazilian agent required  Labelling in Brazillian Portuguese/Date format DD-MM-YYYY  Cost $5K new and renewal but audits much more  CE data can be used.

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The big 5 regulated Markets -Japan  Ministry of Health, Labor and Welfare (MHLW) ● Government authorities who grant approval of high-risk products (Class III).  Pharmaceuticals and Medical Devices Agency (PMDA) ● PMDA is an Independent administrative agency, but actually a part of MHLW. PMDA is in charge of all practical procedure for registration of high risk products (Class III) and quality management system (QMS) conformity examination. Government authorities who grant permission of foreign site for manufacturing.  Certification Body ● There are 13 certification bodies licensed by MHLW at present. Certification body is similar to notified body in Europe and can certify some kind of medical devices and middle risk IVDs (Class II). They conducts also QMS conformity examination for IVD (Class II). AMJ is using TUV SUD and BSi.  National Institute of Infectious Diseases (NIID) ● NIID will perform evaluation for some high risk tests such as HIV, HBsAg, Chlamydia using sample panel during the registration process.  Pharmaceutical Affairs Division in Local Government ● Government authorities who grant permission of Japanese site for manufacturing and distribution.

The Organisation for Professionals in Regulatory Affairs

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