The medical device market is highly regulated to maintain safety for patients and the performance of devices. In the United States, the 510k Medical Device submission process is one of the significant regulatory avenues through which manufacturers sell their products. As a medical device manufacturer, it might be helpful to learn about the 510k process … Read more
Today’s global market sees consumers prioritizing the safety of the products and assessing the trust factor of the brands. For most customers now, this is a dealbreaker. It’s more evident in the case of food, drugs, cosmetics, and medical devices. One of the main considerations or cues that consumers look at is the certification of … Read more
Do you want to make a breakthrough in the U.S. market with food, cosmetics, medical devices, and PPE. You will need to obtain U.S. FDA Certification first for these products, regulated by the government. This certificate safeguards public health by ensuring product safety. Since 1906, the FDA has protected consumers, impacting nearly 20% of global … Read more
Having US FDA Certification is crucial for medical device manufacturers to enter into the US market. Let’s learn how to get FDA Approval for Medical Devices in India through this article. Step 1: Understand the FDA Classification System Before getting FDA Approval, you must understand the FDA Classification system which is divided into three classes. … Read more
There is huge demand for food products and other items such as Drugs, Cosmetics, Colour Additives, Medical Devices, supplements, PPE Kits, etc. So, if you plan to export food products or any other such item to the USA, you must know about FDA compliance. Mandatory FDA Compliances for Exporting Products to USA 1. US FDA … Read more
The United States Food and Drug Administration (FDA) plays a pivotal role in ensuring the safety and efficacy of products available in the market. So, If you have received US FDA Certification or plan to get it, you must know about the process to verify US FDA Certification. Process to verify US FDA Certification The … Read more
FDA approval means a product has been fully tested for safety and effectiveness. This includes lab research, clinical trials, and checks on manufacturing. Products that meet these standards gain FDA approval, allowing them to be used by the public. In this article, you can find the List of FDA-approved products & “not approved” products. What … Read more
The manufacture of eye drops at the Chennai-based business has been halted by India’s Central Drugs Standard Control Organization (CDSCO) after the US FDA reportedly connected 55 adverse event instances to contaminated eye drops. Let’s read the latest updates for this news. US FDA suspends eye product production at Global Pharma site The Food and … Read more
It’s natural for us to think that everything FDA-cleared or authorised has undergone extensive testing, but that isn’t necessarily true. It is essential to be aware of the differences between US FDA Clearance vs US FDA Approval for Medical Devices. In this article, you will get to know about the US FDA Clearance vs US … Read more
Are you want to export products in the USA, you need to comply with certain US import and export formalities. One such mandatory requirement you need to fulfil is US FDA certification. It is a basic requirement that you need to export products such as food, drugs, cosmetics, color additives, medical devices, supplements, and even … Read more