Contact us today for a free consultation with our Indonesia medical device regulation experts regarding Indonesia medical device registration for your product. Indonesia has strong economic growth, an expanding middle class, and an urbanizing population. Western diseases are becoming more prevalent, provid...
Medical device registration in Indonesia includes administrative documents such as a device labeling, device description, including, features, intended use, indications, instructions for use, contraindications, warnings, precautions, potential adverse effects, and other relevant specifications. Some devices may...
Under the Drugs and Cosmetics Act, the regulation of the manufacturing, sale, and distribution of drugs and devices is primarily the concern of state authorities. Central authorities are responsible for approving new drugs, controlling the quality of imported drugs, coordinating the activities of state...
“The team at Asia Actual has seamlessly guided us through the intricate process of compliance to the Indian Medical Device Regulation and helped unravel a challenging situation based on prior inaccurate guidance. From initial assessments to the submission of regulatory documentation, every step was exe...
The company noted that the importance of this approval is amplified by the increasingly stringent medical device regulations within ASEAN. Indonesia follows the ASEAN Medical Device Directive (AMDD), which seeks to establish international standards for the regulation and safety of medical devices. ...
Among those are the European Medical Device Regulation (MDR) and In Vitro Diagnostics Medical Device Regulation (IVDR), which defines several cybersecurity requirements in annex I of the regulation under the “general safety and performance requirements”. The United...
Freyr Provides Medical device regulatory consulting support for medical devices and IVD companies that span across device registration, classification, and market access of products in compliance with Country-specific regulations across the globe.
discuss the latest advancements in medical technology, regulatory efficiency, and the role of AI in transforming the industry. Highlights included updates from the Malaysian Medical Device Authority (MDA) that showcased their commitment to driving regional leadership in medical device regulation and ...
Highlights included updates from the Malaysian Medical Device Authority (MDA) that showcased their commitment to driving regional leadership in medical device regulation and innovation. Read full story Blog Article Pure Global 2024 Year in Review As 2024 comes to a close, Pure Global proudly ...
Highlights included updates from the Malaysian Medical Device Authority (MDA) that showcased their commitment to driving regional leadership in medical device regulation and innovation. Read full story Blog Article Pure Global 2024 Year in Review As 2024 comes to a close, Pure Global proudly ...