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    Overview of Annex I, In Vitro Diagnostic Directive and the new In Vitro Diagnostic Regulation

    This article provides an overview of Annex I, Essential Requirements 98/79/EC and helps clarify understanding of the new content of Annex I, General Safety and Performance Requirements. It is aimed at regulatory professionals who will benefit from having knowledge of In Vitro Diagnostic Medical Devices General Requirements and Essential Requirements (ERs) as well as requirements for risk management, software, labeling, self-testing devices and instructions for use. Int...
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    MDSAP Changes Aim to Reduce Audit Times

    With an eye on a 1 January 2019 deadline for transitioning to only Medical Device Single Audit Program (MDSAP) quality management system certificates accepted for medical device license applications by Health Canada, the MDSAP consortium has implemented a couple of changes to speed up audits. The changes follow comments received by Health Canada from Canadian medical device license holders regarding the current audit-time model for MDSAP and subsequent annual survei...
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    Guest Editorial: Does Nutrition Have a Role in Disease Management?

    This editorial is meant to encourage discussion and thinking about the value of diet and nutrition in the management of disease and a regulatory framework that would be useful in the US to protect public health and provide benefit to individuals who live with chronic disease or an increased risk of such diseases. Introduction The current regulatory approach, with respect to food and nutrition, tends to categorize individuals as consumers or patients and yet these stat...
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    Organizational Culture and Memory in Managing Risk in the Medical Device Industry

    This article discusses the importance of organizational culture and memory in the medical device industry's risk management practices. The authors cite new data from an academic study and an existing FDA study of medical device industry participants to suggest risk management practices are not often an integral part of a medical device organization's culture although many organizations claim to have a "culture of quality." Introduction According to the Italian Renaissan...
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    ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry

    This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability. 1, 2 Introduction While the pharmaceutical industry is globalized, regulations are regionalized. This means a Marketing Authorization Holder (MAH) can manufacture a product a...
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    Testing and Implementing a Web-Based, Country Regulatory Information Management System

    This informal case study highlights the benefits of having structured, reliable information on country regulatory requirements by leveraging the content from a web-based platform. Introduction Philips began a collection of country regulatory information on paper almost 20 years ago. Over time, the collection moved to spreadsheets and files on shared servers, and then to the company's intranet. By 2015, it had grown into a site with hundreds of pages of data on countri...
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    The Measure of Quality

    This article details how regulatory professionals can measure the quality of the outputs generated from the quality department. Additionally, the terms Quality Assurance (QA), Quality Control (QC) and quality management are often erroneously used interchangeably. Included are details about how these terms differ. So often we hear about how important quality is and that companies take pride in their quality or are focused on quality. It is one thing to suspect or to try...
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    How Will ISO 13485:2016 Impact Your Relationship With Suppliers?

    • 22 November 2016
    This article covers how the new ISO 13485 standard 1 affects risk management for suppliers. The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated standard will alter the way device makers interact with suppliers, from supplier selection to the management of supplier relationships. What the new Standard Says About Risk One particularly notable change with ISO 13485:2016 2 is the addition of more explicit ris...
  • Feature ArticlesFeature Articles

    How Will ISO 13485:2016 Impact Your Relationship With Suppliers?

    This article covers how the new ISO 13485 standard 1 affects risk management for suppliers. The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated standard will alter the way device makers interact with suppliers, from supplier selection to the management of supplier relationships. What the new Standard Says About Risk One particularly notable change with ISO 13485:2016 2 is the addition of more explicit ris...
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    Draft CFDA Guidance on Drug Data Management Practices

    The China Food and Drug Administration (CFDA) has recently issued a new draft guidance document on data integrity, covering the entire data lifecycle from R&D to commercial production and distribution. This article is a translation of the summary of the draft guidance. On 10 October 2016, CFDA issued draft guidance of drug data management practices for public comment. 1 Its purpose as detailed in Chapter I is the regulating the management of relevant data during th...
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    Asia Regulatory Roundup: CFDA Releases Draft Guidance on Data Management (18 October 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Proposes Change to Rare Disease Threshold in Orphan Drug Rethink The Therapeutic Goods Administration (TGA) of Australia is proposing to change its definition of rare diseases as part of an overhaul of its orphan drug regulation. If implemented, the revised regulations will allow drugs that treat more common diseases to qualify for orphan medicine status, but only...
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    Regulation, Substantiation Requirements and Enforcement of US Dietary Supplement Claims

    This article discusses claim categories for dietary supplements and recent related regulatory development and enforcement activity to help those who market dietary supplements understand the evolving regulatory climate, legalities and substantiation requirements. Introduction A recent survey reveals 68 percent of American adults take dietary supplements. 1 Users of dietary supplements report taking such products for overall health and wellness, as well as for specifi...