Software as Medical Device, India – Registration Requirements
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 […]
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Price Capping in India by NPPA
The National Pharmaceutical Pricing Authority (NPPA) in India is a regulatory body responsible for controlling and regulating the prices of pharmaceuticals, including medical devices. It periodically identifies and notifies specific medical devices that come under price control, and fixes their […]
Read MoreBSI New Certification to Mitigate Antimicrobial Resistance Risk in Antibiotic Manufacturing
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 […]
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TUV SUD Inspects IVD Medical Devices’ Cyber Security
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 […]
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 give medical devices with CE […]
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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 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 […]
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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 working days, MDA will remove […]
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MDA 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 […]
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