• US FDA’s Voluntary Cosmetic Registration Program (VCRP) and Prerequisites

    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. The VCRP is essential for all cosmetic manufacturers or distributors as it provides comprehensive...

  • Swissmedic’s New Medical Device Regulations
    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. These provisions are designed to offset the negative consequences in the...

  • 5 Steps to Effectively Place Cosmetic Products on the EU Market

    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. Here we explain five (05) critical steps to practice while securing a compliant market entry for...

  • FSSAI Announces New Category for Sweets & Savouries

    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. In addition, there are sweets containing cereal, starch or grain as the main...

  • Ordinance Update for INMETRO Certification: New Changes in Conformity Assessment Requirements
    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...

  • Compliant 510(k) Submissions – Key Aspects to Consider
    July 29, 2021 Medical Devices

    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. According to this principle, the new device should demonstrate substantial...

  • Decode the EU MDR and IVDR QMS Requirements for Medical Devices
    July 29, 2021 Medical Devices

    Implementing and maintaining a Quality Management System (QMS) is mandatory to launch medical devices in the global markets. Having an effective QMS should embody all the procedures and processes covering all aspects from design to production, packaging and distribution. It must become a continuous pursuit for every medical device organization to update their QMS, as per the directives set...

  • COVID-19- Evolving avenues within Regulatory space.
    July 28, 2021 Regulatory Affairs

    Modern-day research and advancements have changed the dynamics of the life sciences landscape. Governments & Health Authorities are constantly facing new challenges amidst the paradigm shift from the pre-COVID era to the present-day scenario. Such a challenging environment brought about an end-to-end evolution of the industry, from new drug development to supply chain management....

  • ISO 27001 Certification: Medical Devices Cybersecurity Compliance
    July 28, 2021 Medical Devices

    With the rapid development and integration of software into medical devices, there is an increase in data breaches and cyber-attacks on public and private medical devices information systems. This ultimately leads to unwanted exposure of an organization’s confidential information and patient’s data and creates chaos in information security and legal systems. Therefore, medical device...

  • Requirements for Chemical Labels in the US

    Occupational Safety and Health Administration (OSHA), in alignment with the United Nations’ Globally Harmonized System of Classification and Labeling of Chemicals (GHS), has adopted new hazardous chemical labeling requirements as a part of its recent revision of the Hazard Communication Standard, 29 CFR 1910.1200 (HCS). The revision is made to ensure improved quality and consistency in the...

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