Innovations in medical devices have increased manifold in recent years. This acceleration can be especially attributed to the vast development in cloud computing and the Internet of Things (IoT). Similarly, Software as a Medical Device (SaMD) has seen an increase in demand and remains a major contributor to the overall growth of the device industry.
The 510(k)-clearance program, also known as Pre-Market Notification (PMN), is US FDA’s device review pathway to ensure safe and effective entry of medical devices into the US territory. US FDA requires manufacturers of the majority of Class II devices and a few Class I and III devices to obtain 510(k)-clearance.
The emergence of digital health technologies has fast-tracked the evolution of the healthcare sector. New-age healthcare products like wearables, telemedicine, and clinical decision-making tools use Artificial Intelligence (AI) and Machine Learning (ML) algorithms. Global Health Agencies, including CDSCO, are gearing up and devising new regulations to address the transformation.
There are various Economic Operators (EOs) who play a vital role in a device supply chain while delivering them to the point of use. Given the importance of each role, the Swiss Medical Device Ordinance (MedDO; SR 812.213) has set out the roles and responsibilities for each of these EOs. The three (03) major economic operators (EOs) in the supply chain are the Swiss Authorized Representative (Swiss AR/CH-Rep), importers, and distributors.
Brazil is the largest cosmetic market in the Latin American region. Increasing consumer awareness and a rising disposable income ensure steady market growth. Major international cosmetic brands also have a presence in this attractive market.
As a cosmetics manufacturer, it is necessary to stay informed about the changing regulations across the globe. A failure to adhere to region-specific regulations often results in disciplinary action from the concerned Authorities.
As it is quite inevitable that the transition period for the Brexit is not going to extend, numerous Regulatory changes or updates are expected to emerge from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). In the same context, MHRA has recently issued a guidance on pharmacovigilance procedures and post transition requirements for Qualified Person Responsible for Pharmacovigilance (QPPV) and Pharmacovigilance System Master Files (PSMF) for the UK authorized products.
Claims are an integral part of the packaging and labeling of any food product or a food supplement. They provide necessary information about the food product to the buyer to help them make an informed buying decision. Before moving forward to the importance of claims in food products, first let’s understand what are claims? Claims are statements or phrases on a product label/ pack or advertising or promotional material to express the product performance/ its usage/ indication/ application.
Demand for cosmetics is consistently growing, worldwide. All thanks to the online product sale, increased beauty consciousness and younger generation’s lifestyle standards. On the other side, apart from meeting the consumer’s and market demands, there is an increasing responsibility on cosmetic product manufacturers to address the Regulatory bodies and end-user’s expectations of cosmetic product safety.
Every year, FDA regulates more than 190,000 medical devices pertaining to different classes. In order to provide better healthcare, the agency is striving continuously to update the pathways through which these devices are being submitted. In a recent press release, FDA announced that the agency is looking at the potential aspects to update the 510(k)-clearance pathway for medical devices.