The US Food and Drug Administration (FDA) defines Clinical Outcome Assessment (COA) as a narration and reflection of how a person feels, functions or survives. The medical device manufacturers may opt to include Clinical Outcome Assessments (COA) in the Regulatory submissions for their device approvals such as PMA and 510(k).
- August 6, 2021 Medical Devices
- August 5, 2021 Medical Devices
Many Medical devices and Invitro Diagnostic (IVD) manufacturers gain market authorizations or device approvals in Australia using the conformity assessment certification issued by the EU Notified Bodies.
Below are the various factors affecting or impacting device registration in Australia.
- July 31, 2021 Cosmetics Regulatory Services
Voluntary Cosmetic Registration Program (VCRP) is a reporting system that is used by cosmetics manufacturers and distributors within the US. The VCRP provides information to the FDA about cosmetic products marketed in the United States, such as frequency of use, commercial commitment, etc.
- July 30, 2021 Medical Devices
You might be aware, in the context of pending agreements between Switzerland and the EU, there are certain modifications/amendments made to the Medical Devices Ordinance (MedDO) and the Federal Council approved supplementary provisions for implementing medical device regulations, which are in force since May 26, 2021.
- July 30, 2021 Cosmetics Regulatory Services, Regulatory Affairs
Cosmetic Regulation 1223/2009 imposes various requirements when it comes to placing a cosmetic or personal care product on the European market. Many cosmetic manufacturers and importers sometimes face adversities as they may not be able to keep up and comply with the complex regulations in the EU.
- July 29, 2021 Food and Food Supplements
India has a rich tradition of sweets, snacks and savories with a difference in taste, texture and ingredients. Traditional milk-based sweets are mostly prepared from Khoya, Chhena, sugar and other ingredients such as maida, flavors and colors, e.g., Peda, Barfi, Milk Cake, Gulab Jamun, Rasgulla, Rasmalai, etc.
- July 29, 2021 Medical Devices
The Brazilian Medical Devices Market is growing significantly and is expected to reach USD 1.8 billion by 2023. Medical devices in Brazil are regulated by the National Health Surveillance Agency (ANVISA). Some medical devices require additional safety certification and accreditation by the National Institute of Metrology, Standardization and Industrial Quality (INMETRO) before the registration at ANVISA.
- July 29, 2021 Medical Devices
To ensure the safety and efficacy of medical devices entering the US market, the US FDA requires every manufacturer to submit a mandatory 510(k) pre-market notification. It is mainly applicable for Class II devices and a few Class I and Class III devices and is based on the principle of substantial equivalence.
- July 29, 2021 Medical Devices
Implementing and maintaining a Quality Management System (QMS) is mandatory to launch medical devices in the global markets. Having an effective QMS should embody all the procedures and processes covering all aspects from design to production, packaging and distribution.
- July 28, 2021 Regulatory Affairs
Modern-day research and advancements have changed the dynamics of the life sciences landscape. Governments & Health Authorities are constantly facing new challenges amidst the paradigm shift from the pre-COVID era to the present-day scenario. Such a challenging environment brought about an end-to-end evolution of the industry, from new drug development to supply chain management.