HSC Global Team
A team of consultants and auditors specialising in medical device regulation.
Back to the blog9 articles in this column
Regulatory affairsRegulatory Radar: What Changed for Medical Devices in August 2026
August 2026 brought regulatory movement on four fronts at once. The FDA, the European Union, ANVISA and three Asian authorities all changed the rules in the same month.
ANVISABrazil Registration Holder: How Foreign Manufacturers Sell Medical Devices in Brazil Without a Local Entity
ANVISA does not accept registrations under a foreign company's name. Without a legal entity in Brazil, there is no registration, and without a registration, there is no importation and no sales.
QualityISO 19011:2026: What Changed in the Standard Governing Management System Audits (and Why the New Guidance Already Applies to You)
ISO 19011, the standard guiding management system audits, reached its fourth edition in May 2026. As a guidance standard, it has no transition period and applies from publication. The most significant changes concern remote and hybrid auditing, virtual locations, reliable digital evidence and auditors' digital competence.
EventsHospitalar 2026: HSC Global Connects Brazilian and International Regulatory Partners
HSC Global Group took part in Hospitalar 2026 at São Paulo Expo, connecting Brazilian and international manufacturers to its ANVISA, FDA, EU MDR, MDSAP and ISO 13485 regulatory consultancy services. Over the four days of the fair, the team met industry leaders seeking to navigate Brazilian and international regulatory requirements with confidence.
ANVISAClass III in Panic, Class II on Alert: The UDI Lesson Your Company Cannot Ignore
A historical scenario on the costs of late UDI planning, preserved with editorial context. Consult current ANVISA requirements before acting.
QualityISO 10993-1:2025 Has Officially Been Published: The Transformation of Medical Device Biological Evaluation Has Reached Brazil
The sixth edition of ISO 10993-1, the leading standard for medical device biological evaluation, was published in November 2025 and fundamentally changes how biological safety is assessed.
MDSAPWhat Sets Ordinary MDSAP Training Apart from a Programme That Transforms Professionals
How to assess an MDSAP programme: technical foundations, syllabus, format, materials and certificate. Explore HSC's current 42-hour live online edition.
MDSAPWhy Medical Device Companies Are Rushing to Obtain MDSAP Certification Now
The market offers a unique window: government investment, easier exports to 5 countries and a shortage of qualified professionals. Why MDSAP certification has become a priority and how your company can prepare early.
MDSAPMDSAP Lead Auditor: Why This Certification Is So Valuable in the Market
Explore an MDSAP lead auditor's skills and HSC's current programme: 42 hours, live online, AU P0002.011 and November 2026 cohorts.