Regulatory Testing from Start to Certificate

    Welcome to 360 Compliance
    360

    FDA emergency performance standards

    The US Food and Drug Administration (FDA approval) has established emergency market access pathways known as Emergency use Authorizations (EUA) to help maintain reliable supplies of medical devices and equipment needed during the ongoing COVID-19 public health crisis.

    Under FDA’s EUA program, manufacturers have been able to produce and distribute ventilators, in-vitro diagnostic testing kits, and personal protective equipment (PPE) without having to undergo standard premarket reviews by the agency.
    However, FDA may rescind an EUA designation at any time, at which point a manufacturer should be prepared either to withdraw its device fully from the US market or seek full premarket authorization from the regulator.

    Although FDA determines EUA designations on a case-by-case basis, general guidelines have emerged regarding the extent to which manufacturers must meet various safety and performance requirements, including those of the IEC 60601 and related series of standards.

    EUA guidance: Partial 60601 compliance

    In order to assiat manufacturers navigate FDA approval EUA qualification requirements and obtain the designation, the Association for the Advancement of Medical Instrumentation (AAMI) has published guidelines focused on bringing ventilators and associated respiratory devices to market in the US during the coronavirus pandemic.

    These guidelines pertain primarily to IEC 60601 standards for safety and performance of medical electrical equipment, and to what extent devices must comply with these standards to qualify for EUA designation.

    -For ventilators, the AAMI guidelines provide supplements to requirements of IEC 60601-1 as well as the ISO 80601-2-80 standard for device safety requirements and cover both Design and Disclosure components.

    -For resuscitator systems, the guidelines provide supplemental performance requirements related to IEC 60601-1, as well as add safety requirements; Design and Disclosure components are covered here also.

    -For CPAP/BiPAP, additional essential performance requirements for IEC 60601-1 and ISO 80601-2-70 are included, plus changes and additions to safety requirements as well as guidance documents for Design and Disclosure.

    Source – UL & FDA updates.

    360Compliance provides Testing & Certification for type approval services and global market access in 195 countries. With proven expertise in worldwide regulations, 360Compliance can help your company shorten time to any market, minimize risks and manage the regulatory process from A-Z.

    Contact us at contact@dev.lm-studio.co.il/360

    Share this:

    You may also be interested

    Cambodia-TRC
    Cambodia TRC Regulatory Updates
    March 21, 2024
    On December 11th, 2023, the head leader of Cambodia's Telecommunication Regulator of Cambodia (TRC) issued a notification to all officers regarding the review of type approval documents, emphasizing the importance of consistency between the information provided in test reports and that submitted by clients. This notification clarified that previously accepted practices, such as using the product name and country of origin as claimed by the client, should now align precisely with the details presented in the test report. Following discussions and confirmations, TRC officers reaffirmed on December 27th, 2023, that this new rule must be adhered to for all future projects seeking type approval. For submissions with one country of origin, the test report must indicate the CoO. In cases where a product has more than one country of origin, the report should display one CoO, with any additional CoOs declared in a separate declaration letter. Moreover, TRC explicitly stated that reports lacking any indication of country of origin will not be accepted under these new guidelines. This adjustment aims to enhance accuracy and consistency in reviewing type approval submissions. Streamlining TRC Type Approval with Support from 360Compliance 360Compliance specializes in navigating TRC's type approval process, ensuring documents precisely reflect the country of origin per the latest guidelines. Our team offers expert advice and comprehensive services, including preparing test reports and submitting declaration letters. Partner with us to meet TRC's stringent criteria, minimize delays, and effectively secure type approval for your products. Let 360Compliance handle the complexities of compliance, allowing you to focus on your core business activities with peace of mind. Contact us today to learn more about our services and how we can help you achieve regulatory compliance in Cambodia.
    SIRIM_MCMC_Certification
    Malaysia SIRIM-MCMC Regulatory Updates
    March 21, 2024
    The Malaysia SIRIM CMCS Department, responsible for MCMC certification, recently implemented a significant update regarding Intellectual Property (IP) Forms for Type Approval applications. These forms replace the trademark authorization letter to improve efficiency and accuracy in approvals. The new IP Forms categorize trademark declarations based on whether the applicant has obtained authorization from the trademark/brand owner. For applicants who have been authorized, the required documents include evidence of a registration certificate issued by the Intellectual Property Corporation of Malaysia (MyIPO). Or an equivalent foreign organization, along with an Intellectual Property (IP) Authorization Letter (eTAC/FOR/01-8). On the other hand, if the applicant has not obtained written consent and authorization to use the trademark/brand, they must submit the Intellectual Property (IP) Undertaking form issued by the applicant (eTAC/FOR/01-9). Importantly, these new forms are effective immediately and will be used for all new projects. They mark a significant shift in SIRIM's approach. The organization can now accept brands/trademarks that have not been officially authorized by the brand owner. However, in such cases, the importer must provide a written declaration accepting responsibility. Furthermore, the new Brand name authorization process requires both the Brand owner and the Importer to co-sign the Brand name authorization letter. This updated procedure aims to enhance transparency and accountability in the approval process for Type Approval applications, ultimately benefiting both applicants and consumers in Malaysia. Simplifying SIRIM Certification with 360Compliance Navigating the latest SIRIM and MCMC certification requirements can be complex, especially when introducing new Intellectual Property (IP) Forms. 360Compliance is here to simplify this process for you. Our team knows the latest SIRIM updates, including the new eTAC/FOR/01-8 and eTAC/FOR/01-9 forms. We provide comprehensive support, ensuring your Type Approval applications are complete, accurate, and compliant with the latest regulations. From obtaining the necessary authorizations to submitting the correct IP Forms, we manage every step of the process efficiently. Partner with 360Compliance to streamline your SIRIM certification journey, minimize delays, and maximize compliance. Contact us today to ensure your products easily meet Malaysia's certification standards.
    India Regulatory Updates
    March 21, 2024
    India TEC issued a notification in January 2024 regarding generic exemptions for products without available test labs.  In January 2024, India's Telecommunications Engineering Centre (TEC) issued a significant notification regarding generic exemptions due to the absence of available test laboratories within the country. These exemptions represent a crucial development, indicating that specific parameters no longer require the submission of test reports if customers cannot provide them. It's important to note that while these exemptions are in place, ILAC reports for CE/FCC are still subject to regulations based on the specific product category. This means that evaluation criteria for these reports vary depending on the nature of the product. Furthermore, TEC has specified product categories that continue to accept ILAC reports. Notably, the validation for these exemptions has been extended until June 30, 2024, with the potential for further extensions based on the evolving circumstances. These updates underscore TEC's commitment to adapting regulations to facilitate market access while maintaining stringent quality standards in the telecommunications sector. TEC approves testing exemptions for several product categories under their mandatory testing and certification program The Telecommunications Engineering Centre (TEC), under the Ministry of Communications, recently issued a notification regarding the approval of test requirements exemptions for certain product categories that necessitate mandatory testing and certification. This development signifies a significant step towards streamlining regulatory processes and promoting efficiency in the telecommunications sector. By exempting certain products from rigorous testing requirements, TEC aims to facilitate faster market access for manufacturers while maintaining high standards of quality and safety. This initiative aims to reduce costs and accelerate the introduction of innovative products to benefit industry stakeholders and consumers. How 360Compliance Can Streamline TEC Certification? 360Compliance offers expert guidance for navigating TEC certification complexities, especially with recent updates. We're adept in TEC requirements and ILAC report evaluations, ensuring compliance. Our understanding of exemption criteria and certification process management aids manufacturers and distributors in adjusting smoothly. Partnering with us secures strategic advantages for quicker market access, keeping with India's telecom quality standards. We simplify compliance, focusing on your innovation and growth in a changing regulatory landscape.

    Get in touch to take the next step with 360Compliance

    Contact us