Amended 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:
- March 17, 2021 Chemicals, Regulatory Affairs
- March 16, 2021 Cosmetics Regulatory Services
Are you sure that your cosmetic products or their ingredients are safe for the environment? It’s alarming to hear climatic challenges faced by the world. Maintaining climatic health is one of the major concerns for every individual, and many revolutionary changes have been adopted across various parts of the world to slow down the effects of climate change.
- March 16, 2021 Cosmetics Regulatory Services
Are 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.
- March 15, 2021 Medical Devices
As 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. Preparing a DHF as per the Regulatory requirements and withstanding the Regulatory Agencies’ scrutiny is a key challenge for all the medical devices manufactures and developers.
- March 12, 2021 Cosmetics Regulatory Services
As you may know, South Korea is one of the leading global markets for cosmetic products. However, the impact of COVID-19 has triggered various changes in the regional cosmetics industry. One of the major changes is the shift in consumers’ perception of product safety. Owing to the same, trends like clean cosmetics are expected to increase in South Korea.
- March 12, 2021 Medical Devices
The medical devices industry is considered highly regulated hence device manufacturers must adhere to a strict set of practices, known as, GxP or Good Practices (GMP - Good Manufacturing Practice, GDP - Good Distribution Practice, GLP - Good Laboratory Practice, GCP - Good Clinical Practice and many more).
- March 1, 2021 Medical Devices
The Union Ministry of Health (MoH), India has released a draft Gazette Notification – Medical Devices (Amendment) Rules, 2021. These rules are an amendment to the original “Medical Devices Rules, 2017”, published on January 31, 2017, in the Official Gazette under the Notification No. G.S.R.78(E). The amendment rules read –
- March 1, 2021 Medical Devices
Health Canada has clarified its stand on the research use only testing kits related to COVID-19. Health Canada regulates the import and sale of medical devices and IVDs (In-vitro Diagnostic Devices) in the Canadian market.
- February 16, 2021 Medical Devices
The medical devices industry is considered as highly regulated. Hence, devising a right Regulatory strategy will be a potential approach and a great value-added contribution to avoid Regulatory roadblocks. Especially, medical devices manufacturers willing to launch their products in the ASEAN geographies have to walk through stringent regulations, as different markets portray different Regulatory requirements.
- February 9, 2021 Food and Food Supplements, Regulatory Affairs
To streamline the food facility registration for manufacturers in the United States (US), the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) (Pub. L. 107-188) has added section 415 to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the Section 415 of the FD&C Act (21 U.S.C.