{"id":393,"date":"2021-06-15T12:53:40","date_gmt":"2021-06-15T12:53:40","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?page_id=393"},"modified":"2025-03-07T12:39:56","modified_gmt":"2025-03-07T12:39:56","slug":"use-of-international-standards-by-medical-device-regulators","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/international-standardization\/use-of-international-standards-by-medical-device-regulators\/","title":{"rendered":"Use of International Standards by Medical Device Regulators"},"content":{"rendered":"\n

The Coalition works with industry and governments around the world to minimize regulatory-related barriers between patients and life-saving and life-improving medical technologies.<\/p>\n\n\n\n

Central to this work is global medical device regulatory convergence. Regulatory convergence is the process of aligning the technical regulations, standards, and conformity assessment criteria for medical devices in all countries toward a single set of internationally harmonized criteria.<\/p>\n\n\n\n

The World Health Organization urges public health authorities around the world to economize their limited public health resources by relying on international standards as a basis for national regulations and by relying on the conformity assessment results of other jurisdictions. The government funds required to develop a regulation in isolation, to test a product that has already been tested, or to certify a product that has already been certified are funds that a health agency can use to strengthen post-market surveillance, to digitize import review procedures, to accelerate good manufacturing practice inspections, to modernize IT infrastructure, or to upgrade regulatory inventory. More broadly, such economized public health resources can be used to improve healthcare delivery by hiring and training physicians, nurses, and procurement staff; by investing in hospitals, clinics, and other points of care; by upgrading health IT systems, and to otherwise improving patient treatment and care delivery.<\/p>\n\n\n\n

The documents listed below summarizes the primary international reference documents for medical device regulators regarding regulatory convergence and the use of international standards.<\/strong><\/p>\n\n\n\n

International Health Guidance<\/h2>\n\n\n\n

1. World Health Organization – Global Model Regulatory Framework for Medical Devices Including IVD Medical Devices (all), including:<\/a><\/p>\n\n\n\n

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Stepwise Approach (Section 4 – page 21)
Reliance and Recognition (Section 4.11 – page 21)<\/span><\/div><\/div><\/div>\n\n\n\n
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4.2 Basic-level controls and their enforcement (page 23)<\/span><\/div><\/div><\/div>\n\n\n\n
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4.2.1.2 \u2013\u00a0\u201c\u2026The preferred, but optional, way by which the manufacturer may demonstrate conformity with the Essential Principles is to apply voluntary international standards that are appropriate and relevant. The law should include provisions allowing the regulatory authority to formally recognize such standards for that purpose (see section 4.3.1.3)\u2026\u201d<\/em><\/span><\/div><\/div><\/div>\n\n\n\n
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4.3.1.3 \u2013\u00a0\u201c\u2026At the expanded level, the regulatory authority may wish to establish a procedure to identify national versions of international standards that it accepts as providing presumption of compliance to specific Essential Principles, i.e. \u201crecognized standards\u201d. Preference for recognition should be given to international standards, e.g. those of the International Organization for Standardization (ISO)and the International Electrotechnical Commission (IEC), regional standards and the national versions of international standards. It is also important that national standards correspond to the current version of international standards. As international standards are periodically revised, national standards will have to be revised accordingly and the authority should establish a transition period for manufacturers to adopt the new versions. To maintain the necessary flexibility in utilizing standards, it is better to adopt a system of recognizing standards through guidance documents or guidelines than placing the standards into legislation;\u00a0they can then be updated to stay current and can be revised much faster than legislation can be updated.<\/em><\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n

2. World Health Organization – Annex 11 \u201cGood regulatory practices in the regulation of medical products\u201d<\/a><\/p>\n\n\n\n

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(page 272)
\u201cA sound legal framework, adoption of international norms and standards<\/strong> and recruitment and development of competent staff are necessary but not sufficient conditions<\/strong> to ensure \u201cgood regulatory oversight\u201d. These measures must be combined with good regulatory practices (GRP) that guide all individuals in organizations entrusted with regulating medical products in formulating decisions that are clear, transparent, consistent, impartial, proportionate, timely and based on sound science and legislation.\u201d<\/span><\/div><\/div><\/div>\n\n\n\n
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(page 275)
\u201cRegulatory convergence. A voluntary process whereby the regulatory requirements in different countries or regions become more similar or \u201caligned\u201d over time. Convergence results from gradual adoption of internationally recognized technical guideline documents, standards<\/strong> and scientific principles, common or similar practices and procedures or the establishment of appropriate domestic regulatory mechanisms that align with shared principles to achieve a common public health goal.\u201d<\/span><\/div><\/div><\/div>\n\n\n\n
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(page 277)
\u201cIncreasingly, policy-makers and regulatory authorities are adopting modern models of regulation that are responsive to resource constraints while meeting the challenges posed by scientific development, globalization, rising public expectations and public health emergencies. Weak or inefficient regulatory systems can limit access to safe, effective and, high quality medical products and pose a threat to public health. As countries strengthen their regulatory capacity, they must ensure that their regulatory systems are science-based, that they adhere to international standards and guidelines and that their approach leverages the work of other, trusted regulatory authorities and institutions when possible.<\/strong> To this end, countries are encouraged to formulate and implement policies and strategies that promote international collaboration, convergence, harmonization, information- and work-sharing and reliance as part of GRP. WHO is establishing a framework for evaluating NRAs and regional regulatory systems and for designating those that meet the requirements of WHO listed authorities.\u201d<\/span><\/div><\/div><\/div>\n\n\n\n
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(page 284)
\u201cAll regulatory authorities must be accountable to the public, the bodies they regulate and the government for their actions and decisions as part of good governance and accountability. In the context of GRP, regulatory authorities are accountable when they are: (i) responsible for acting according to certain standards and commitments<\/strong>, (ii) answerable for their actions and (iii) willing to face the consequences when standards or commitments are not met.\u201d<\/span><\/div><\/div><\/div>\n\n\n\n
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(page 291)
\u201cInternational guidelines and standards should always be considered in developing new guidance documents, and regulators should support international harmonization and convergence. National requirements beyond international standards should be well justified.\u201d<\/strong><\/span><\/div><\/div><\/div>\n\n\n\n
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(page 293)
\u201cTerms <\/strong>should be defined in order to avoid ambiguity or misinterpretation. When possible, they should be consistent with established international norms, standards and harmonized guidelines<\/strong>. As noted previously, international standards and guidelines are particularly important vehicles for promoting common regulatory language, convergence and international cooperation.\u201d<\/strong><\/span><\/div><\/div><\/div>\n\n\n\n
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(page 293)
\u201cRegulations and supporting guidelines should be reviewed periodically to ensure that they reflect the authority\u2019s current practices and expectations, are adapted to scientific and technological developments and are aligned with current international standards and guidelines, when applicable.<\/strong> Review and revision of a guideline should include consideration of the consequential changes in other guidelines, which should be revised simultaneously.\u201d<\/span><\/div><\/div><\/div>\n\n\n\n
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(page 301)
\u201cRegulatory decisions and decision-making should be based on scientific foundations and accurate data rather than intuition or arbitrariness. Science-based decisions provide for consistent, predictable regulatory outcomes. Adherence to international standards and guidelines is a key enabler of science based regulatory decision-making.\u201d<\/strong><\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n

3. World Health Organization – Annex 10 \u201cGood reliance practices in the regulation of medical products: high level principles and considerations\u201d<\/a><\/p>\n\n\n\n

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(page 250)
\u201cEqually, the authorities being relied upon should have and maintain competence and operate within a robust, transparent regulatory system based on international standards and guidelines, as well as GRP, and a well-functioning quality management system.\u201d<\/span><\/div><\/div><\/div>\n\n\n\n
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(page 251)
\u201cNRAs that practise reliance should establish and publish a list of reference regulatory authorities, with the criteria used in identifying them. They should decide and establish the criteria they will use for selecting reference authorities, such as application of international standards<\/strong>, long standing recognition in the international community, proximity and commonality of medical products.\u201d<\/span><\/div><\/div><\/div>\n\n\n\n
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(page 255)
\u201cConvergence and harmonization of requirements, standards and guidelines are important enablers of regulatory cooperation and reliance. The more similar requirements, standards and guidelines are, the greater the opportunity for collaboration and reliance\u2026\u201d

\u201c\u2026Differences in standards and practices, however, do not prevent one authority from relying on another, particularly when the relying authority has limited capacity and expertise. The system on which an NRA relies should be at least equivalent to or superior to the standards it applies. As a matter of good practice, NRAs should rely on assessments or decisions from reference regulatory authorities that apply international standards and guidelines.\u201d<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n

4. World Health Organization – Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics<\/a><\/p>\n\n\n\n

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(pages 1-2)
\u201cRecent horizontal International Organization for Standardization (ISO) standards for medical devices place increased emphasis on the importance of post-market surveillance. The ISO standard on quality management systems (QMS) for medical devices, used by most manufacturers, requires a post-market surveillance system to be in place. Furthermore, in the 2019 revision of the ISO standard on risk 1 management of medical devices requirements on post-market surveillance were also strengthened. The specific ISO guidance document on post-market surveillance for manufacturers of medical devices was recently published. Together, these documents provide a framework for conducting post-market surveillance and using post-market surveillance data to ensure the continued quality, safety and performance of medical devices.\u201d<\/span><\/div><\/div><\/div>\n\n\n\n
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(page 45)
\u201cNRAs should apply international standards in force for the respective category of medical devices.\u201d<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n

5. International Medical Device Regulators Forum (IMDRF) documents (all), including:<\/a><\/p>\n\n\n\n

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2a. IMDRF N47 – “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices”<\/span><\/div><\/div><\/div>\n\n\n\n
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Annex A: Use of Standards in Meeting Essential Principles<\/span><\/div><\/div><\/div>\n\n\n\n
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B. Use of Standards by Regulatory Authorities having Jurisdiction
\u201cThese standards should, wherever possible, be standards incorporating the thinking of the global marketplace and help support the development of consistent expectations between Regulatory Authorities having jurisdiction. In the absence of international consensus standards, it may be appropriate for Regulatory Authorities having jurisdiction to accept the use of regional or national consensus standards or industry standards.\u201d<\/em><\/span><\/div><\/div><\/div>\n\n\n\n
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2b. IMDRF N51 – “Optimizing Standards for Regulatory Use”<\/span><\/div><\/div><\/div>\n\n\n\n
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B. Use of Standards by Regulatory Authorities having Jurisdiction
1.2 Role of standards in regulatory processes
Although regulatory processes among IMDRF regions differ, RAs [regulatory authorities] share the common objectives to ensure medical device safety and performance and to protect public health. International consensus standards are based upon science, technology and experience and generally reflect the best experience of industry, researchers, consumers, regulators and other experts worldwide. IMDRF members affirm their collective belief that reliance upon consensus standards is a key element of a robust regulatory framework. Appropriate use of standards will promote efficiencies and innovation while facilitating objective assessment of device safety and performance.\u201d<\/em><\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n

International Trade Obligation<\/h2>\n\n\n\n
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World Trade Organization – Agreement on Technical Barriers on Trade<\/span><\/div><\/div><\/div>\n\n\n\n
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Article 2.4 \u2013\u00a0\u201cWhere technical regulations are required and relevant international standards exist or their completion is imminent, Members shall use them, or the relevant parts of them, as a basis for their technical regulations\u2026\u201d<\/em><\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n

ISO Guidance on use of International Standards<\/h2>\n\n\n\n
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ISO Guide 21-1 \u201cRegional or national adoption of International Standards and other International Deliverables \u2014 Part 1: Adoption of International Standards\u201d<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n

See also:<\/p>\n\n\n\n

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Using ISO and IEC standards to support public policy<\/span><\/div><\/div><\/div>\n\n\n\n
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Medical Device Regulatory Convergence<\/span><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n

For more information, please visit Contact Us<\/a><\/p>\n\n\n\n

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REGULATORY COALITION PRINCIPAL MEMBERS<\/h3>\n\n\n