The Drugs Controller General of India (DCGI) has instructed state drug regulators to take necessary action and direct all the manufacturers on how to upload their manufacturing sites and formulation data on Sugam portal which will strengthen the drug regulatory system by way of improving the transparency, accountability as well as accessibility of the drugs in the country.
State FDA’s Commanded by DCGI on Sugam Portals Update Read More »
One of the new key regions of obligations that should be characterized is the individual or people in charge of regulatory compliance per Article 15. In the event that more than one individual keeps up this job (to enable the maker to meet the openness necessity), the divisions of obligation should be recorded as a hard copy, for example, in sets of expectations, goals,
Roles and Responsibilities: QMS and IVDR Read More »
This regulatory topic has turned out to be progressively relevant, in front of the commencement to the EU\’s new medical device and in-vitro diagnostic rules, set to produce results on May 26, 2020 and 2022, respectively.
Launch Procedure for Medical devices regulation Read More »
For Medical Device Registration In South Africa, the South African government has established a new agency to manage the new medical device and pharmaceutical regulatory systems being produced in the country.
Medical Device Registration In South Africa Read More »
Here is a complete step-by-step guide for FDA medical device approval process. If you are looking for FDA medical device approval process for your medical device then you are in the right place. Medical devices, from ideation to post-launch assessment, are directed in the United States by the U.S. Food and Drug Administration (FDA) under
FDA medical device approval process step-by-step guide Read More »
design control are uncommon nowadays for medicinal devices to be straightforward. The huge number of devices presently require an application or some kind of software to work. There can be a few layers which include unpredictability. It’s not simply exceptionally ongoing devices either; consider items that have been around for quite a while; for instance,
GET TO KNOW BRIEF ON MULTI-LEVEL DESIGN CONTROLS Read More »
The government is planning to introduce amendments to the Drugs and Cosmetics Act, 1940 which will provide compensation to patients if they are sold a faulty medical device by a manufacturer or importer. The decision has been taken in the backdrop of the uproar caused earlier this year in India and abroad over defective hip
Govt designs a new principle to get patients remuneration for faulty medical devices Read More »
The UK government has allowed Brexit draft agreement concerning the withdrawal of the UK from the European Union along with a connection statement and outline of a political statement on the future association between the UK and the EU. This means that the positioning on the market of medical devices may continue undisturbed on both
Brexit Draft Agreement Get To Know What It Means For Medical Devices Read More »
Implement new technologies such as the cloud, mobility, Big Data, and the Internet of Things (IoT) into care models, leading medical devices to become increasingly connected – to the internet, hospital networks, and each other. The use of connected medical devices such as insulin pumps and implanted pacemakers brings the risk of hacking directly to
New FDA Guidance Will It Boost Medical Device Cybersecurity? Read More »
Medical Device Benefit And Risk Analysis For 510(k)s In association with the safety and efficacy of the applicant’s device, the FDA will consider “any credible benefit to health from the use of the device against any potential risk of trauma or illness from such use, among other applicable factors.” The FDA recently released final guidance
