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  • Regulatory NewsRegulatory News

    COCIR Pushes to Harmonize Device Standards

    The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) issued a position paper on Tuesday to facilitate the harmonization of medical device standards. COCIR’s position paper set forth six recommendations on harmonizing device standards, citing an array of existing challenges such as the assessment process and the fixed publication schedule. Harmonized standards need revision to reflect changes to and increased regul...
  • Regulatory NewsRegulatory News

    CDRH Proposes New IMDRF Work Item on Standards

    Medical device industry delegates and global regulatory authorities are looking to further support their collaboration with standards development organizations (SDOs) through a newly proposed liaison program. Scott Colburn, director of the standards program at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), pitched an International Medical Device Regulators Forum (IMDRF) new work item (NWI) during a workshop hosted by the IMDRF s...
  • Regulatory NewsRegulatory News

    Transition to ISO 13485:2016 Comes to an End

    The three-year transition period for ISO 13485:2016 officially ended Thursday and as of Friday all ISO 13485:2003 certificates are now null and void, regardless of their original expiration date. The role of the revised standard plays into major regulatory initiatives worldwide aimed at international harmonization. Both the 2003 and the 2016 version of the global consensus standard—developed by the International Organization for Standardization (ISO—co-existed until Thu...
  • Feature ArticlesFeature Articles

    Standardization Best Practices for Managing Regulatory Processes: Part 1

    This article reviews the most common standardization challenges, including inconsistent data definition, data capture and processes and suggests system consolidation and automation will only succeed if data is standardized and processes are harmonized. Introduction In a three-part series, authors will share rich insights from research and explore identified challenges from a lack of standardization, manual processes and fragmented systems and offer practical advice an...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Drug Safety, Traceability at Forefront of China’s Health Reform Plan (16 February 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Puts Drug Safety and Traceability at Forefront of Healthcare Reform Program China has committed to bolstering the safety controls and traceability requirements that cover its local drug market. The commitment, which was made at a meeting of the State Council, is part of a raft of healthcare reform initiatives that are collectively intended to lessen China’s reliance ...
  • Feature ArticlesFeature Articles

    Bringing Structure to Substance Information

    This article discusses compliance challenges pharmaceutical companies face with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standard for structured substance information. To support continuous pharmacovigilance oversight improvement within the EU, the European Commission has mandated pharmaceutical companies’ adherence to ISO IDMP standards by 1 July 2016 . 1 These standards collectively outline the data ...
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    How can Medical Device Labeling be Standardized? FDA Study Aims to Find Out

    US regulators plan to launch a new study of medical device labeling in the hopes of determining if a standardized format could help healthcare providers to better understand the risks and benefits of a device prior to its use. Background If you purchase a pharmaceutical product in the US, you can be almost certain that the label on that product will look identical to every other drug product you've ever purchased. That's because the US Food and Drug Administration (FDA)...
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    With Eye on Improving Quality, Indian Regulator gets First ISO Certification

    India’s regulatory authority has announced that one of its offices has become the first in the country to become certified by the International Organization for Standardization (ISO). In a press release, the Central Drugs Standard Control Organization (CDSCO) said that its Ahmedabad office received ISO 9001:2008 certification for its quality management system (QMS) on 16 February 2015. Background ISO 9001 is a set of standards for QMS in organizations where it is imp...