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New Zealand’s Medicines and Medical Devices Safety Authority is proposing fee increases for the majority of its services, including reviewing new devices and GMP inspections. Read More
The FDA recommended factors to consider and precautions to take for premarket submissions of multiple function device products, noting there is no all-encompassing approach for the wide variety of multiple function devices. Read More
The FDA released final guidance that provides policy clarification for ultrasonic diathermy devices as well as information devicemakers should submit in their premarket notification submissions. Read More
The International Medical Device Regulators Forum released updates on regulatory works in progress in member countries following its March 20-22 IMDRF meeting in Shanghai. Read More
The European Union’s Medical Device Coordination Group released a trio of guidances that clarify devicemakers’ responsibilities for implementing unique device identification systems under the EU’s new Medical Device Regulations. Read More
Health Canada is sticking to its compliance deadline of Jan. 1, 2019, for devicemakers selling products in Canada to transition to the Medical Device Single Audit Program, but it is making adjustments to help manufacturers comply. Read More
Following consultation with stakeholders, India’s Drugs Controller General adopted essential principles for safety and performance of medical devices marketed in India. Read More