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 […]
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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 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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Cabinet 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 MoreMeasures are Taken To Enhance Healthcare.
China’s most recent policy or regulation initiatives to strengthen its national healthcare service system will facilitate the provision of high-quality healthcare services at the community level, assist in resolving issues that these regulation concern the public most in the sector, […]
Read MoreFDA Approval for OTC Hearing Aids
Hearing loss affects 30 million adults in the US, with a high number of people affected by it. Only one-fifth of those who could benefit from a hearing aid seek intervention. To increase access to hearing aids, the FDA Approval […]
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