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 of consumers. A guideline to […]
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, will enable businesses that sterilize […]
Read MoreSCHEER – 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 phthalates in certain medical devices. […]
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 WHO Recommendations Table in Annex […]
Read MoreFDA 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 can result in significant injury […]
Read MoreMDA 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 working days, MDA will remove […]
Read MoreMDA Implementing the Electronic Medical Device Registration Certificate
The Medical Device Authority MDA will start using electronic medical device registration certificates starting on May 2, 2023. Once the application is complete (complete status) and the registration money is paid, the establishment can get the medical device registration certificate […]
Read MoreFDA Approval For Wound Treatment in Epidermolysis Bullosa
Vyjuvek, a herpes simplex virus type 1 (HSV-1) vector-based gene therapy, has been given approval by the FDA for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) who have mutations in the collagen type VII alpha 1 […]
Read MoreCabinet approves the Policy for the Medical Device Sector
Introduction: Policy 2023 intends to support the Medical Device industry’s orderly expansion in order to satisfy the public health goals of access, affordability, quality, and innovation in India. The policy puts forth a plan for the industry’s rapid expansion in […]
Read MoreCosmetic Medicine Are Now Under Stricter Regulation
A guideline to strengthen oversight of the medical cosmetology industry was recently released by eleven central departments, including the State Administration for Market Regulation, the National Health Commission, and the Ministry of Public Security. The regulation are to control the […]
Read More