It is crucial for Regulatory bodies to monitor the vast range of consumer products available in their market. With new products entering the market regularly, this task becomes increasingly complex for Regulatory Authorities. However, it is important to detect potentially harmful products to ensure product compliance and consumer safety.
- August 24, 2021 Consumer Healthcare, Regulatory Affairs
- August 12, 2021 Chemicals, Regulatory Affairs
With the outbreak of the global pandemic, Malaysia continues to fight the war against COVID-19. This period has been overwhelming for both the Malaysian Pharmaceutical industry as well as the consumers. As public and personal hygiene became the first defense against the virus, change in consumer behavior has been observed, especially regarding hygiene-related products in the Malaysian market.
- August 6, 2021 Medical Devices
The Thai Food and Drug Administration (TFDA) has revised its medical device regulations to ensure the safety and effectiveness of the devices marketed in Thailand and to harmonize the regulations with the other ASEAN countries. There have been changes in the medical device classification, registration pathways and process, timelines and fees.
- August 6, 2021 Medical Devices
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 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.