It is well known that from January 1, 2021, medical devices to be placed on the UK market are obliged to follow a new Regulatory regime. Currently, the UK market is a witness to many Regulatory changes, with the impact of Brexit.
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April 12, 2021 Medical Devices -
March 30, 2021 Pharmaceutical, Regulatory AffairsANVISA of Brazil received the approval to become a member of PIC/s (Pharmaceutical Inspection Co-operation Scheme) in November 2020. Considering the pandemic situation, for the first time in PIC/s history, the assessment was completed in a written procedure as opposed to at a meeting; on Jan 1, 2021, the PIC/s committee welcomed ANVISA as their 54th valuable member.
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March 30, 2021 Medical DevicesMaintaining a Quality Management System (QMS) is the foundation to demonstrate Regulatory compliance in the medical devices industry. QMS is a structured system of procedures and processes, covering all the aspects of design, manufacturing, risk management, supplier management, complaint handling, clinical data, storage, distribution and product labeling of medical devices.
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March 24, 2021 Compliance, Audit and Validation, Regulatory AffairsNational Medicines Regulatory Authority (NMRA) of Sri Lanka has declared the ‘List of Countries’ to be exempted from the manufacturing site audits. Essentially, this list refers to the respective health authorities in the specified countries, also termed as ‘’Reference Countries.’’ The health authorities included in the list are:
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March 19, 2021 Medical DevicesIn the context of COVID-19, there is an increasing interest in understanding the PPE regulations. To meet the growing interest, TGA the Australian Regulatory Authority has issued a guidance, which covers an overview of how PPEs are regulated, information for PPE manufactures and the PPE standards.
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March 18, 2021 Chemicals, Regulatory Affairs, Regulatory Software & ServicesUnder the Classification, Labeling and Packaging of substances and mixtures (CLP) regulation, Chemical companies, who wish to place hazardous chemical mixtures such as paints, coatings, detergents, solvents, etc. in the European market are required to provide notifications of the hazards in their products.
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March 18, 2021 Chemicals, Cosmetics Regulatory Services, Regulatory AffairsEnvironmental Protection Agency of the US is prioritizing the attempts to develop and use New Approach Methods (NAMs) for chemical testing. This new approach will help in reducing the usage of animals as subjects in chemical testing while ensuring the protection of human health and the environment. NAMs are equivalent to “alternatives" to animal testing.
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March 17, 2021 Chemicals, Regulatory AffairsAmended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Toxic Substances Control Act (TSCA) requires the United States Environmental Protection Agency (EPA) to evaluate the safety of existing chemicals. How can manufacturers evaluate safety? Here is a stage-wise approach that EPA follows for the chemical risk evaluation process:
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March 16, 2021 Cosmetics Regulatory ServicesAre we really driven towards the fast-paced cosmetic world? The real purpose of using cosmetics is not just to look good to the human eyes, but it also helps to enhance the beauty of the inner self and hence using them has become the core factor. A country like China has broken the momentum and cosmetics is one of the most rapidly growing industries.
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March 15, 2021 Medical DevicesAs part of the Safe Medical Device Act in 1990, the FDA mandated the Design History File (DHF), which contains all the development documentation pertaining to a medical device/product/diagnostic, which is generated by the design control process.