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Definition of a Medical Device around the global market

What is a Medical Device? The simplest definition of a medical device is a product used for treatment except for medicines. It is imperative to understand if the product classifies as a medical device and apply the regulations after defining it properly. An essential aspect of defining a medical device is its intended use. Intended use is the purpose of the device specified by the manufacturer. In this article, we have brought up the definition of “medical device” for a few major countries....
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Current Good Manufacturing Practices (cGMPs) of the FDA

The FDA introduced current Good Manufacturing practices (cGMP) to maintain a system that provides proper design, monitoring, and control of manufacturing processes and facilities. The cGMP standards ensure products’ identity, strength, quality, and purity by requiring manufacturers to maintain proper control over their manufacturing processes. This system helps the manufacturer avoid as many failures and errors as possible. The “C” in cGMP refers to “current,” which...
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EU MDR Market Surveillance Activities

Market surveillance is the activity carried out by the competent authorities according to Article 93 of MDR 2017/745 to ensure that products on the market comply with the relevant laws and regulations and with the current EU health and safety requirements. Maintaining market security in Europe and promoting consumer safety and business trust is vital. Suppose the medical device poses an unacceptable risk to the health or safety of the patients, users, or other people or any other aspects of the...
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FDA’s Adverse Event Reporting for Cosmetics

Cosmetic ingredients and products are not required to have FDA clearance before being sold in the U.S. The only exception is colour additives, which need to be authorised for their intended purpose (apart from the colouring agents used in coal-tar hair dyes). Companies and individuals that sell cosmetics have a legal obligation to guarantee the security of their products. The FDA requires trustworthy evidence that shows that a cosmetic product is harmful when used as directed by its label or in...
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