The European Union Medical Devices Regulation (EU MDR) 2017/745 defines the scope of the sterile medical devices as devices that must be microorganism-free (bacteria, viruses, etc.). Class I devices with sterile function can also obtain a self-certification, but it differs in terms of requirements compared to other sub-categories of Class I devices.
- October 12, 2022 Medical Devices, Regulatory Affairs
- October 11, 2022 Medical Devices, Regulatory Affairs
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.
- October 7, 2022 Regulatory Affairs, Regulatory Software & Services
In September 2022, the USFDA released a revised technical conformance guide for electronic Common Technical Document (eCTD) v4.0. The guide provides specifications, recommendations, and general considerations while submitting eCTD-based electronic submissions to the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER).
- October 6, 2022 Pharmaceuticals, Regulatory Labeling
A Summary of Product Characteristics (SmPC) is an easy-to-access and product-specific resource enclosed with all the essential information about a product. The document includes the forms, clinical parameters, and pharmacological properties written and updated by organizations depending on their research and knowledge of a specific medicinal product.
- October 4, 2022 Pharmaceuticals, Regulatory Artwork Services
Artwork is a powerful branding tool in the pharmaceutical industry as it helps organizations create the correct brand perceptions.
- September 27, 2022 Pharmaceuticals, Publishing & Submissions
During the COVID-19 pandemic, Real-World Data (RWD) and Real-World Evidence (RWE) were essential sources of information for the United States Food and Drug Administration (USFDA) to expedite the approvals of COVID-19 vaccines and therapeutics and to allow other clinical studies to progress under the changing circumstances. For post-approval studies currently, the FDA ensures the appropriate RWD is utilized to create RWE.…
- September 26, 2022 Food and Food Supplements
The Food Safety and Standards Authority of India (FSSAI) released a Draft Notification on September 14, 2022, amending the Food Safety and Standards (Labeling & Display) Regulations, 2020. These regulations may be called the Food Safety and Standards (Labeling & Display) Amendment Regulations, 2022. It shall come into force on the date of their final publication in the Official Gazette.
- September 26, 2022 Biologicals, Generics, Pharmaceuticals, Health Authority Updates
The National Medical Products Administration (NMPA) of China recently released a comprehensive draft amendment for implementing the China Drug Administration Law (DAL).
- September 22, 2022 Pharmaceuticals, Health Authority Updates
According to the CMDh practical guidance for Marketing Authorization Holders (MAHs) of nationally authorized products, the evaluation of nitrosamine impurity or cross-contamination in a marketed product is a critical criterion. Nitrosamines are proven to be carcinogenic and can affect the overall output of the formulated product.
- September 21, 2022 Chemicals, Cosmetics Regulatory Services
As public awareness of environmental issues is increasing rapidly, many cosmetic companies are engaging their focus on natural and environment-friendly emulsifiers and chemicals to be used in their products. The advantages of ‘green’ beauty products go beyond fashion. Newer research approaches have outlined the amount of toxicity in conventional cosmetics.