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117 results found for: fda
Digital Health is fast emerging and is growing rapidly. New technologies such as telemedicines, Artificial Intelligence (AI) and Machine Learning (ML), Wearables for Glucose Monitoring, ECG etc are constantly evolving. Healthcare regulators across the world are devising regulations to help […]
The Food and Drug Administration Modernization Act of 1997 (FDAMA) included the De Novo classification option as an alternate pathway for classifying novel medical devices that had been automatically classified as Class III after receiving a “not substantially equivalent” (NSE) […]
The Medicines and Healthcare Products Regulatory Agency has stated that new regulatory recognition pathways for medications will be formed utilizing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore, and the United States. The newly recognized channels provide the […]
This article deals In accordance with the Pharmaceuticals and Medical Devices Act (PMD Act) of Japan, foreign businesses that wish to produce pharmaceuticals, quackery products, active pharmaceutical ingredients (APIs), or medical devices abroad and import them into Japan must register […]
BSI, the business improvement and standards company, has developed a new certification to mitigate the risk of antimicrobial resistance (AMR) in antibiotic manufacturing. The certification, called the Minimized Risk of Antimicrobial Resistance (AMR) certification, will offer independent third-party verification that […]
The growing digital connectivity of medical infrastructure is resulting in complicated systems with a plethora of diverse interfaces that are potentially vulnerable to assault. The IVD requires producers to provide proof of cyber security before releasing their products to the […]
The TGA made a commitment to support the MHRA‘s new Regulations worldwide recognition framework for pharmaceuticals. Following the UK’s exit from the European Union, a new international recognition framework for medicines has been developed specifically for them. These international recognition […]
The MHRA revised its guidelines to make clear its stance and reflect its intention to extend the acceptance of CE-marked medical devices on the British market beyond June 30th, 2023. A statutory document that will give medical devices with CE […]
According to a representative of the State Administration for Market Regulation, after the industry’s quick development, prominent issues like unethical medical practices, fake goods, false advertising, and price fraud emerged, endangering the health and interests of consumers. A guideline to […]
CDRH is establishing a Radiation Sterilization Master File Pilot Program to assist businesses in developing less troublesome regulatory methods for sterilizing licensed medical equipment, such as switching radiation sources. The pilot program, which is optional, will enable businesses that sterilize […]