TGA Supports MHRA’s New Regulations
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 […]
Read MoreMedical Devices with Extended CE Certification Are Now Accepted On The UK Market
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 […]
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The NMPA Enhanced Regulation of Cosmetic Medicine
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 […]
Read MoreRadiation Sterilization Master File Pilot Program Announced by CDRH
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, […]
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SCHEER – Updated Guidelines on Phthalates in Medical Devices
The Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER) has been asked by the European Commission (EC) or EU Regulation to update the recommendations for weighing the benefits and risks of the presence of […]
Read MoreMDA Regulations on Third Edition Guidance Document on Medical Face Masks and Respirators
The Medical Device Authority (MDA) regulations created this guidance document to aid the healthcare community and the industry in adhering to the Medical Device Act’s (Act 737) laws and requirements. The new recommendation updates the […]
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FDA Recalls Draeger Medical’s Seattle PAP Plus and Breathing Circuit/Anesthesia Kits
This article deals with FDA device approval which Recalls Draeger Medical’s Seattle PAP Plus and Breathing Circuit/Anesthesia Kits due to the risk of loose or detached components restricting breathing support. The use of these devices […]
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MDA will Withdraw the Medical Device Registration and Change Notification Application
This article deals with the change of notification application and withdrawal of medical device registration by MDA. If the medical device registration (new and re-registered) application and change notification application is not completed within 30 […]
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