Jump to navigation
Search
The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.
Read More
Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.
Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.
Cosmetic claims are an integral part of any cosmetic label. They are a great marketing tool to help consumers make an informed choice amidst a range of similar products. To ensure that the users are well informed about the cosmetic products, the European Commission (EC) regulates cosmetic claims under Article 20 of the European Cosmetics Regulation No.1223/2009. The purpose of the regulation...
In 2016, the United States Food and Drug Administration (FDA) released final rules for the revised Nutrition Fact Labels, a part of which will be effective from the year 2020. It was initiated by the USFDA to help consumers make informed food choices and promote a healthy diet and lifestyle. As per the new nutrition guidelines, manufacturers with annual sales of more than USD 10 million or...
The changing landscape of the life sciences industry makes it necessary for the companies to adapt to the global Regulatory requirements, immediately. Companies need to evolve themselves for the necessary transition with each mandatory requirement from the health authorities. One such mandatory requirement in recent times is the Electronic Common Technical Document (eCTD) format, an electronic...
Malaysia is one of the leading markets in the cosmetics and personal care products industry. In 2019, the Malaysian cosmetics market was valued at USD 1.6 billion with a CAGR of 4.2%. According to the industry experts, the unprecedented growth of the industry is majorly a result of increasing population and employment levels, which are driving the consumers to be more conscious about the...
The Ministry of Food and Drug Safety (MFDS) of South Korea is modifying its Cosmetics Safety Standards to align with the European Union (EU) legislation for cosmetic ingredients. The purpose of these modifications is to increase the safety of the cosmetic products and streamline the Regulatory framework for cosmetic ingredients. The updated regulations will be applicable to all the cosmetics...
The Ministry of Health and Prevention (MoHAP), in collaboration with the UAE’s Food Security Office, has launched the National Nutrition Guidelines. The guidelines are a part of the Ministry’s efforts of developing sustainable food safety systems and deploying radical and innovative solutions. The purpose of introducing these guidelines is to build a healthier and sustainable future by...
Two years ago, in 2017, the Food and Drug Administration (FDA) identified a tentative list of Class II medical devices to be exempted from premarket notification requirements. The list came with limitations for certain type of devices then. Referring to the same, the FDA on Oct 24, 2019, announced the proposed final list of Class II devices to be exempted from 510(k) requirements. The latest...
Invention has no limits. It is a continuous process. With many medicinal products and medical device rolled out in the market, the year 2019 has been a boon for Life sciences industry. For good, the industry has seen a significant growth. All thanks to the governance of global health authorities.
The global health authorities were quick enough to alter their governing approaches in...
As part of the EU’s Medical Devices Regulation (MDR), the Council of the European Union (EU) has again published a new Corrigendum and a set of corrections. The new corrigendum gives manufacturers of certain Class I devices an additional four years for transition and compliance. This read similar to the first corrigendum, which not only gave a "grace period" to certain higher-risk devices that...
In a recent notification, the South Korean national health authority - Ministry of Food and Drug Safety (MFDS) announced that the Agency no longer requires the submission of full summary technical documentation (STED) files for the registration of high-risk (class IV) medical devices.
The MFDS...
North America
South America
East Europe
Europe
North Africa & Middle East
Southern Africa
APAC
Australia & New Zealand
Japan & South Korea
Get Blog Updates Delivered Straight to Your Inbox
