top of page
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.
Get Started
Get Started
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...
-
Oct 4, 20245 min read
246
0
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...
-
Oct 4, 20245 min read
354
0
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....
-
Oct 2, 20247 min read
226
0
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...
-
Sep 27, 20246 min read
130
0
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...
-
Sep 24, 20247 min read
321
0
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...
-
Sep 16, 20246 min read
158
0
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...
-
Sep 15, 20245 min read
322
0
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....
-
Sep 14, 20246 min read
820
0
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....
-
Sep 9, 20248 min read
271
0
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...
-
Sep 8, 20248 min read
142
0
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....
-
Sep 6, 20248 min read
353
0
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...
-
Sep 3, 20248 min read
744
0
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...
-
Aug 21, 20244 min read
211
0
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...
-
Aug 14, 20243 min read
355
0
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...
-
Aug 14, 20244 min read
126
0
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...
-
Aug 14, 20243 min read
68
0
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...
-
Aug 13, 20245 min read
341
0
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...
-
Aug 12, 20244 min read
331
0
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...
-
Aug 2, 20244 min read
30
0
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...
-
Aug 1, 20244 min read
34
0
ISO 14971:2019: Risk Management of Medical Devices
ISO 14971 2019 Risk Management of Medical Devices
-
Jul 2, 20247 min read
198
0
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...
-
Jun 30, 20244 min read
150
0
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...
-
Jun 30, 20244 min read
203
0
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...
-
Jun 30, 20245 min read
429
0
Ready to scale up?
Get Started
Podcast
Insights
Trainings
Explore our wide range of training modules built to help your team be future-ready and keep up with the latest trends in the MedTech sector.
Forum
Get involved in discussions with industry experts, innovators and entrepreneurs about all things MedTech right here.
We cater to 70+ Countries
Expand the impact of your MedTech solution worldwide. Discover how we can help you launch your product across the globe here.
About the Grant
Gain a chance to bring your MedTech idea to life and create real-world impact. Registrations close on February 28, 2024.
About Medtech InnovateIO by Artixio
Learn all about our journey right from celebrating MedTech innovations to fostering new MedTech solutions.
bottom of page