ANVISA NEW REGULATION FOR POST-APPROVAL CHANGES TO MEDICAL DEVICES: RDC 340/2020
On March 3, 2020, Anvisa published a new regulation “RDC 340/2020” that classifies the changes made to approved medical devices in Brazil, into three categories based on the level of risk .
FDA New Policy on Emergency Use Authorization (EUA) of In Vitro Diagnostics of Coronavirus
On February 2020, FDA issued a Policy that allows CLIA certified high-complexity testing laboratories to use their validated diagnostic tests to detect the SARS-CoV-2 virus in specimen while they are preparing for EUA submission to FDA.
NMPA Emergency Approval of Imported Medical Devices in China: What this means for Foreign Manufacturers
The Coronavirus outbreak in China has led to an extraordinary demand of some medical devices. The NMPA (Chinese health authority) started granting emergency approval to some imported medical device, provided that they meet certain regulatory and quality standards.
FDA Draft Guidance on Performance Criteria for Safety and Performance Based Pathway for Soft Daily Wear Contact Lenses
On March 4, 2020, US FDA published a new draft guidance to allow manufacturers of eligible daily wear soft (hydrophilic) contact lenses to use new performance criteria pathway to support substantial equivalence instead of a direct comparison of the performance of their device to that of a predicate device during 510(K0 submission
China’s Communist Party held a meeting on March 4 to study the current state of Coronavirus in China.
The Standing Committee of the Political Bureau of the Central Committee of the Communist Party of China held a meeting on March 4 which was presided over by General Secretary Xi Jinping to study the current priorities for the prevention and control of the novel coronavirus epidemic and the stabilization of economic and social operations
The FDA Prepares for the Fourteenth Annual Meeting International Cooperation on Cosmetics Regulation.
The FDA announces on March 3rd that they hold a public meeting regarding the 14th International Cooperation on Cosmetics Regulation (ICCR)- to be held on April 14, 2020.
Singapore announces facilitated Importation of Hand Sanitizers, Masks, Thermometers and Protective Gear
Since January 31, 2020, importers of the certain medical devices do not require an importer’s license from Singapore’s Health Science Authority (HSA).
PMDA Approach to Artificial Intelligence (AI) based Medical Devices
PMDA has adapted emerging technologies such as AI based medical devices and has reviewed the registration process to make it more efficient.
Mexico Prohibits the importation of electronic cigarettes by presidential decree (02/2020)
The Government of Mexico, concerned about the health of Mexicans, Prohibits the importation of electronic cigarettes by presidential decree.
The FDA publishes Guidance for Nutrition and Supplements Facts Labels for Small Entity Compliance
FDA publishes guidance for final rule intended to help small entities comply with the nutrition facts labeling requirements
The FDA publishes FY 2019 GDUFA Science and Research Report
The FDA’s FY 2019 GDUFA report provides detailed results for 13 areas of focus, including research activities and comprehensive lists of grants and contracts.
Anvisa’s Call Notice 2/2020 : Similar Drug Notice
On Thursday (1/30), Anvisa published Call Notice 2/2020 , aimed at requesting information on similar drugs registered in Brazil.