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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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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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 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 […]
Read MoreFDA Regulations Advance Decentralized Clinical Trials
The FDA Regulations is adopting further measures to facilitate the use of decentralized clinical trials (DCTs), in which part or all trial-related activities take place at places other than conventional clinical trial sites, including medicines, biologics, and devices. The government […]
Read MorePhilippines FDA Regulations Warns Against Purchasing and Using Unnotified Medical Devices
This article deals with the Food and Drug Administration (FDA) regulations warning all healthcare professionals and the general public not to purchase and use unnoticed medical device products such as The FDA regulations confirmed that the above-mentioned medical device product had […]
Read MoreDual-Labelled Names to Transition to Sole Names by TGA
This article deals with the changes to the dual labelling period as of April 30, 2023, by TGA Australia. The labels, Product Information (PI), and Consumer Medicines Information (CMI) papers are now requesting dual labelling for multiple ingredient names used […]
Read MoreNMPA certifies third batch of medical equipment
This article discusses NMPA Certification the decision to implement unique identification of medical devices for some Class II medical devices in order to continue implementing the Regulations on the Supervision and Administration of Medical Devices, the Notice of the General […]
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