South Korea approved guideline for medical devices employing VR, AR technologies

The newly approved guidelines will provide the clearer development path for companies working to commercialise VR and AR products. South Korea’s Ministry of Food and Drug Safety has set official approval guidelines for medical devices that use virtual reality and augmented reality technologies, setting a clearer development path for companies working to commercialise new products…

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INVIMA Registration and Approval of Medical Device in Colombia

Colombia is a sovereign state largely situated in the northwest of South America, with territories in Central America. Marketing your medical device in Colombia requires registration with the National Food and Drug Surveillance Institute (INVIMA), the country’s medical device regulator. The first step towards INVIMA regulatory approval is to determine the correct classification of your medical device. Device classification in Colombia…

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Brazil updates with Innovative Technologies, 3D printing, Accelerated Pathways and biosimilars

Brazil officially is the Federative Republic of Brazil which is the largest country in both South America and Latin America. The Brazilian public health system, the Unified Health System (SUS), is managed and provided by all levels of government, is the largest system of this type in the world. On the other hand, private healthcare systems play a complementary role. Public health services are universal and offered to all…

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Mexican Regulators Recommendation for Medical Devices | Digital Advertising

Medical device market regulators in Mexico have published new simplified guidelines for digital advertising campaigns related to medical devices and other healthcare products. Mexico is the second largest medical device market in the Americas. The market was in 2007 about 2.2 billion US dollars, which per capita is 20 dollars. Most of the medical devices are imported. Medical…

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China FDA Plans To Change Medical Device, IVD Submission Requirements

The China Food and Drug Administration(FDA) has announced plans to relax some of its medical device and IVD submission requirements as well as develop a system for more comprehensive electronic submissions of Chinese market application materials. Easing medical device and IVD registration renewals First, Chinese regulators have proposed (link in Chinese) easing device renewal as well as…

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USFDA New Recommendations for Non-Clinical Bench Performance Test Submissions

The Food and Drug Administration has established requirements for protecting the public health by assuring the safety and effectiveness of a variety of medical products including drugs, devices, and biological products, and for promoting public health by expediting the approval of treatments that are safe and effective. The Center for Devices and Radiological Health is the…

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ANSI UL Medical Device Cybersecurity Standard Receives US FDA Recognition

The US Food and Drug Administration has officially recognized a standard from the American National Standards Institute (ANSI) and UL targeting medical device cybersecurity. FDA’s recognition of ANSI UL 2900-2-1—Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems as an official consensus standard now…

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