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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.
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.
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.
Companion Diagnostics (CDx) are In Vitro Diagnostic devices used in conjunction with therapeutic drugs to determine their suitability for the patients. To place the CDx in the European Union, the manufacturer is required to submit technical and other relevant documents to the Notified Body (NB) for technical and conformity assessment.
Medical devices need an efficient, effective, and readily available user manual. Over time, paper Instructions for Use (IFU) have been the norm in the medical device industry. However, with the advent of electronic technologies, the paper IFU has been replaced by electronic IFU (eIFU).
Design of logical Instructions for Use (IFU) and Operation Manual of medical devices requires an efficient, structured, and organized approach. It is critical for ensuring a medical device user’s safety and comprehension, as IFU and manuals are used to inform the end-user how to use the device.
Medical device industry ensures that users can use medical devices safely, effectively, and efficiently.. Creating Instructions for Use (IFU) for medical devices requires quite a lot of responsibility. It requires a combination of technical communication skills with project management, administrative and legal skills.
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.
Labeling has paramount importance in the medical device industry for ensuring high standards of quality and safety. The labels help educate the end-users or patients about how to use the device, who should use it, how to operate the device safely and what risks it could pose.
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.
As the EU MDR transition deadline is inching closer, manufacturers must execute the labeling requirements with utmost priority and caution and must ensure high standards of quality, and safety for compliance. Prior to execution, understanding the new labeling requirements and accurate implementation is of paramount importance.
e-labeling plays a critical role in the medical devices industry, as it ensures to improve operational efficiency, maintain brand consistency, obtain compliance and support business growth. Hence, the device industry is moving towards adopting end-to-end e-labeling life cycle procedures, starting from label content creation to review and approvals.
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.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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