In an ever-evolving Lifesciences Regulatory arena, expanding to new markets always require a thorough knowledge on regional application formats, dossier content requirements, submission procedures etc. “What Is” is a pool of such regional Regulatory prerequisites that enable organizations or manufacturers understand on-the-ground procedural requirements in detail. EU General Data Protection Regulation (GDPR) EUDAMED: European Database on Medical Devices What Are Quasi-Drugs in South Korea? What Is A Design History File (DHF)? What are TODOKEDE, NINSHO and SHONIN? What is 21st Century Cures Act What is INMETRO Certification? What is Medical Device Reporting (MDR)? What is Medical Device Single Audit Program (MDSAP)? What is QUEST 3+ Submission? What is Todokede? What is a Sunset Clause? What is eCOSMA Registration Who is A Mexican Registration Holder (MRH)?