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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.
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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.
Recently, the SFDA (Saudi Food and Drug Authority) has issued a guidance to clarify the e-IFU (electronic Information for Use) requirements for medical devices in Saudi Arabia. This guidance is issued in reference to the Essential Principles specified in, “Guidance on Requirements for Medical Device Listing and Marketing Authorization (MDS-G5).” It is applicable for medical devices (including...
As you may know, the FDA (Food and Drug Administration) uses Medical Device Reporting (MDR) as one of the post-market surveillance tools, to monitor device performance, to detect potential device-related safety issues and to contribute to benefit-risk assessment of the devices. In order to simplify the procedure of submitting medical devices adverse event reports, recently, the FDA and CDRH (...
After two months of consultation with the food industry, on August 27, 2020, the Singapore Food Agency (SFA) has finally released amendment no. 3 of Food Regulations 2020. The amendment is a step towards updating SFA’s Regulatory provisions to align with the global standards. The purpose of this amendment was to streamline the usage of new food additives and extend the usage of already...
On July 1, 2020, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) was officially replaced by the Australian Industrial Chemicals Introduction Scheme (AICIS). Falling under the Industrial Chemicals Act 2019, the AICIS is a Regulatory scheme, which focuses on supporting cosmetic product manufacturers with easy import of new low-risk chemicals to the Australian market...
Face shields have gained utmost significance as the primary protective equipment to curb the spread of the COVID-19. Considered as a Personal Protective Equipment (PPE), face shield is made up of a transparent window or visor, that protects the face and associated mucous membranes (eyes, nose and mouth) against the potential exposure to infectious diseases. To guide manufacturers in these...
On July 16, 2020, Japan’s Consumer Affairs Agency (CAA) revised the labeling standards for food products in the country. To do so, the CAA appointed a study group to discuss the current labeling system and make necessary changes in it. These changes aim to strengthen the labeling standards for food products in Japan, while streamlining their safe distribution. Here is what the new labeling...
To strengthen the safety of food supplements in South Korea, in July 2020, the Ministry of Food and Drug Safety (MFDS) proposed to add “Precautions for Use” warnings to the label of food products. The proposed changes are applicable to food products with nine categories of ingredients. These nine categories include chromium, beta-carotene, vitamin K, B1, B2, B12, pantothenic acid, biotin, and...
Multiple function device products are medical products that have at least one device function (medical) and one non-device function (non-medical) or other function. Among these, some are subjected to FDA’s Regulatory oversight as medical devices, while others are not. Hence, FDA issued a final guidance addressing the review of medical products that contain both, the medical and the non-medical...
Since the commencement of Brexit transition timelines, the entire medical devices community is underway to understand its impact on future trade and Regulatory relations between the European Union (EU) and the United Kingdom (UK). As noted, the UK left the EU on January 31, 2020, as per the Withdrawal Agreement between both the countries. The agreement brings up a transition period until...
Couple of months back we thoroughly discussed about FDA’s expedited Regulatory pathways during medical emergencies. In that specific explanation as we listed the FDA’s tools and programs for expedited approvals with respect to review and approval of therapies, including biologics, this...
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