Australia - Medical Devices

Australia, Medical Devices, Therapeutic Goods Act, Australian Sponsor, TGA, ARTG

INMETRO Certification; Medical Devices; medical devices class i; UDI Code; sterile packaging; clinical evaluation; IMDRF; ISO 15223-1 symbol; vigilance;

Brazil - Medical Devices

Brazil, Medical Devices, INMETRO Certification, ANVISA Notification and Registration

INMETRO Certification; Medical Devices; medical devices class i; UDI Code; sterile packaging; clinical evaluation; IMDRF; ISO 15223-1 symbol; vigilance;

Canada - Medical Devices

INMETRO Certification; Medical Devices; medical devices class i; UDI Code; sterile packaging; clinical evaluation; IMDRF; ISO 15223-1 symbol; vigilance;

China - Medical Devices

People's Republic of China, Medical Devices Class I,II,III; NMPA, CMDE, Electronic Registration, UDI Regulation

INMETRO Certification; Medical Devices; medical devices class i; UDI Code; sterile packaging; clinical evaluation; IMDRF; ISO 15223-1 symbol; vigilance;

Europ. Economi. - Medical Devices

European Union, Medical Devices, Regulation 2017/745

INMETRO Certification; Medical Devices; medical devices class i; UDI Code; sterile packaging; clinical evaluation; IMDRF; ISO 15223-1 symbol; vigilance;

United Kingdom - Medical Devices

UK (England, Scotland, Wales), Responsible Person, The Medical Devices Regulations 2002, UK Approved Body, Medical Device Classes I, IIa, IIb, III

INMETRO Certification; Medical Devices; medical devices class i; UDI Code; sterile packaging; clinical evaluation; IMDRF; ISO 15223-1 symbol; vigilance;

India - Medical Devices

INMETRO Certification; Medical Devices; medical devices class i; UDI Code; sterile packaging; clinical evaluation; IMDRF; ISO 15223-1 symbol; vigilance;

Japan - Medical Devices

Japan, Medical Devices, Act on Pharmaceuticals and Medical Devices (PMD Act), MHLW, PMDA, Marketing Authorization Holder (MAH)

INMETRO Certification; Medical Devices; medical devices class i; UDI Code; sterile packaging; clinical evaluation; IMDRF; ISO 15223-1 symbol; vigilance;

Korea, Republi. - Medical Devices

Korea, Medical Devices, MFDS authority, Notification/Certification/Approval Process

INMETRO Certification; Medical Devices; medical devices class i; UDI Code; sterile packaging; clinical evaluation; IMDRF; ISO 15223-1 symbol; vigilance;

USA - Medical Devices

USA, Medical Devices, Pre-Market Approval, Pre-Market Notification, Federal Food, Drug, and Cosmetic Act 510(k) requirements, United States Agent

INMETRO Certification; Medical Devices; medical devices class i; UDI Code; sterile packaging; clinical evaluation; IMDRF; ISO 15223-1 symbol; vigilance;

USA - Medical Devices Cybersecurity

IT; OT; Operational technology (OT) controls devices; Information technology (IT) controls data; Threat modelling; Threat modeling; vulnerability; incident; handling; ISMS; data privacy; security asset; network asset, privacy asset; financial asset