• Prepare Your Organization for Remote Audits

    It is well known that COVID-19 has pushed many organizations to drive their auditors and the compliance teams adopt the right technology to perform remote audits. While remote audit techniques are similar to those of traditional audits, they leverage electronic means to obtain audit evidence for evaluations. The way or the procedure for remote audits depends on the business function and the...

  • SFDA Guidance: e-IFU Requirements for Medical Devices
    October 29, 2020 Medical Devices

    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...

  • FDA Announces New Improvements to Electronic Medical Device Reporting (eMDR)
    October 29, 2020 Medical Devices

    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 (...

  • Singapore Food Agency Releases Amendment for Food Regulations

    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...

  • Understanding AICIS – A Detailed Webinar

    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 Market-entry in Canada – Health Canada Standards and Authorization Pathways
    October 22, 2020 Medical Devices

    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...

  • Japan, CAA, Food Products, Food Additives, Labeling, Labeling Standards

    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...

  • MFDS to Strengthen the Safety of Food Supplements

    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: FDA’s Pre-market Review Policy and Submissions

    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...

  • Role of MHRA and Post-Brexit Scenario for Medical Devices in the UK
    October 13, 2020 Medical Devices

    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...

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