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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.
Since 2003, eCTD has been accepted by several Health Authorities around the world. Its standard has evolved incrementally over time. Based on the Health Level Seven (HL7) standard called RPS (Regulated Product Submission), eCTD 4.0 brings in major changes and introduces certain substantial updates.
A drug therapy regimen is diverse for drugs that can be approved to be used in combination with a previously approved drug or simultaneously developed two novel drugs, that synergistically enhance efficacy. Single-drug cancer therapies significantly showcased drug resistance as a major threat for patients undergoing treatments with anti-cancer drugs.
510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent to a legally marketed device (predicate). Devices with moderate risk are required to submit a 510(k) notification, which includes a minority of Class I and III devices and a majority of Class II devices.
Class A IVDs under European Union In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/745 require self-certification. The manufacturer is required to self-declare their product’s compliance with the EU IVDR’s requirements and affix the CE marking.
The medical device industry is undergoing continuous transformation to comply with the ever-changing Regulatory guidelines introduced by global Regulatory authorities to ensure strict controls over device performance and safety.
The need for continuous improvement in product quality, reliability, and safety arises due to recalls, updates of Regulatory requirements, and the desire to gain a competitive advantage.
With the enactment of NMPA’s Regulations on the Supervision and Administration of Medical Devices - Order 739 in 2021, the medical device registration process in China has undergone substantial changes. The NMPA has implemented several process-related changes to streamline and improve the device registration process.
Brazil is the largest economy in Latin America and the most promising medical device market. Medical device market in Brazil is governed by the Brazilian Health Regulatory Agency, ANVISA.
The medical device industry landscape is ever-changing owing to globalization and the advent of newer technologies. Due to these constant changes and developments, medical device organizations need robust change management systems.
Risk management is a critical activity across all phases of the medical device lifecycle as it directly affects the safety and well-being of patients. Risks are unavoidable; however, they can be curtailed if companies are aware of impending hazards and follow effective risk management procedures.
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