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Global Insights - Devices & IVDs
Access insights from our industry experts on everything from country-specific regulations, case studies, facts to the latest advancements in the MedTech industry.
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Oct 4, 20245 min read
ANVISA ESPR for Medical Devices in Brazil : RDC 848/2024
The Essential Safety and Performance Requirements (ESPR) serve as the backbone for ensuring that medical devices are not only effective...
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Oct 4, 20245 min read
ANVISA's Post-Approval Changes in Medical Devices in Brazil : RDC 340/2020
ANVISA (Agência Nacional de Vigilância Sanitária), Brazil's health regulatory agency, plays a crucial role in ensuring the safety and...
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Oct 2, 20247 min read
ANVISA Regulation of SaMD in Brazil : RDC 657/2022
The landscape of healthcare technology is rapidly evolving, and software as a medical device (SaMD) is at the forefront of this change....
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Sep 27, 20246 min read
ANVISA Medical Device Registration in Brazil :Reliance Pathway (IN 290/2024)
The registration of medical devices in Brazil is a critical step for manufacturers looking to enter this expansive market. ANVISA...
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Sep 24, 20247 min read
MFDS Regulation of Medical Devices in South Korea : Korean Good Manufacturing Practices (KGMP) Certification
In South Korea, the regulation of medical devices is primarily governed by the Ministry of Food and Drug Safety (MFDS). A critical...
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Sep 16, 20246 min read
ANVISA RDC 687/2022 : BGMP Certification for Medical Devices in Brazil
As the Brazilian market continues to grow in prominence, ensuring that medical devices meet the highest quality standards is crucial. The...
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Sep 15, 20245 min read
ANVISA Regulation of IVDs in Brazil : Resolution RDC 830/2023
Over the past two years, Brazil's regulatory landscape for medical devices has undergone substantial changes. In 2022 and 2023, Brazil’s...
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Sep 14, 20246 min read
MFDS Regulation of Medical Devices in South Korea
South Korea, known for its advanced healthcare system and technological prowess, has a robust framework for regulating medical devices....
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Sep 9, 20248 min read
Taiwan FDA (TFDA) Regulation of Medical Devices in Taiwan
Taiwan is a significant player in the global medical device market, with robust regulations ensuring safety, efficacy, and quality....
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Sep 8, 20248 min read
Regulation of Medical Devices in Brazil: ANATEL Certification
In Brazil, medical devices must adhere to rigorous regulatory standards to ensure their safety, effectiveness, and quality. A key element...
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Sep 6, 20248 min read
Regulation of Medical Devices in Brazil: INMETRO Certification
Entering the Brazilian market with medical devices requires overcoming various regulatory challenges to ensure safety and compliance....
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Sep 3, 20248 min read
ANVISA Regulation of Medical devices in Brazil
Brazil, the largest economy in Latin America, has a well-established and complex regulatory framework for medical devices. As the...
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Aug 21, 20244 min read
Designated Marketing Authorization Holder (DMAH) for Medical Devices in Japan
Expanding into the Japanese medical device market requires a clear understanding and adherence to PMDA regulatory requirements, including...
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Aug 14, 20243 min read
Regulation of Medical Devices in Japan: PMDA Foreign Manufacturer Registration (FMR)
Japan's medical device market, one of the largest and most competitive globally, presents significant opportunities for international...
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Aug 14, 20244 min read
Registration of Medical Devices in Japan : PMDA Ninsho Pathway
Japan, with its sophisticated healthcare system and significant market potential, presents a lucrative opportunity for medical device...
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Aug 14, 20243 min read
Medical Device Registration in Japan : PMDA Todokede Pathway
Japan's medical device market is a significant and lucrative arena, but accessing it involves understanding and adhering to a complex...
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Aug 13, 20245 min read
Medical Device Registration in Japan : PMDA Shonin Pathway
Japan, with its advanced healthcare system and significant market potential, stands as a lucrative destination for medical device...
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Aug 12, 20244 min read
PMDA Regulation of Medical Devices in Japan
Japan is renowned for its advanced healthcare system and rigorous standards in medical device regulation. The country’s approach ensures...
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Aug 2, 20244 min read
US FDA Post Market Surveillance of Medical Devices in the USA
The premarket phase, while crucial for evaluating a device's initial safety and effectiveness, often cannot cover all potential risks and...
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Aug 1, 20244 min read
Telemedicine and Remote monitoring: Impact on patient care
Telemedicine and remote monitoring are transformative technologies in healthcare that leverage digital tools and platforms to deliver...
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Jul 2, 20247 min read
ISO 14971:2019: Risk Management of Medical Devices
ISO 14971 2019 Risk Management of Medical Devices
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Jun 30, 20244 min read
Understanding IEC 60601 for Medical Electrical Equipment
In the ever-evolving landscape of medical technology, ensuring the safety and reliability of medical devices is paramount. The IEC 60601...
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Jun 30, 20244 min read
SFDA Regulation in Saudi Arabia (KSA) : Classification and Grouping of Medical Devices and IVDs
The medical devices and in vitro diagnostics (IVDs) market in Saudi Arabia is tightly regulated to ensure the safety, efficacy, and...
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Jun 30, 20245 min read
Usability / Human Factor Engineering Studies : Formative and Summative Evaluation of Medical Devices
In the medical device industry, usability is critical not only for the effectiveness of the device but also for patient safety. Proper...
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