• Regulatory NewsRegulatory News

    EU Task Force to Implement New Drug Identification Standards

    The European Medicines Agency (EMA) has announced it is putting together a task force to oversee the implementation of new standards for identifying drugs. The goal of the task force will be to develop a roadmap for EU-wide implementation of identification of medicinal products (IDMP) standards developed by the International Organization for Standardization (ISO). Background EMA recently issued an explanatory document titled Data submission of authorised m...
  • Regulatory NewsRegulatory News

    EMA Explains Centralized Product Database, Talks Future Changes

    The European Medicines Agency (EMA) released a new document intended to clarify data submission requirements for medicines authorized in the European Economic Area (EEA). In the document, the agency discusses the current status of its eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) and talks about planned changes through 2016. Pharmacovigilance in the EU Pharmacovigilance is the process of monitoring the use of drugs after they have entered the market. ...
  • Regulatory NewsRegulatory News

    India Seeks Input on Draft Revisions to Device GMPs

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. India’s Central Drugs Standard Control Organization (CDSCO) is seeking input on draft revisions to Schedule M-III of the country’s Drug and Cosmetic Act , which describes good manufacturing practices (GMPs) for medical devices. The revisions aim to bring the GMP requi...
  • Regulatory NewsRegulatory News

    Public Comment Period Opens on ISO 9001, Major Device Quality Standard

    The International Standards Organization (ISO), an international group whose standards are widely used in the life sciences industry, has finally released a draft of its latest iteration of the ISO 9001 standard for public consultation. Background The standard, which covers Quality Management Systems (QMS), undergoes  a revision process once every five years, and was last updated in 2008 (ISO 9001:2008). The ISO 9001 standard is used extensively throughout the medical...
  • Quality Concerns Lead to Suspension of all Products Manufactured by Canadian Company

    Canadian regulators have announced the suspension of all medical device licenses issued to or otherwise associated with one medical device manufacturer after being made aware of "concerns about the company's management systems and distribution practices." That company, British Columbia-based IND Diagnostic, manufactures a wide variety of diagnostic products, including ones to detect pregnancy, infectious diseases, the presence of recreational drugs and other potential he...
  • ISO Releases New Voluntary Anti-Counterfeiting Standard

    The International Standards Organization (ISO), whose standards are commonly used by the life sciences industry, has released a new standard to allow for uniform authentication standards to combat counterfeit goods, including medicines and medical devices. The standard, ISO 12931: 2012 - Performance criteria for authentication solutions used to combat counterfeiting of material goods , discusses several "authentication solutions," including holograms, tags, and m...
  • Feature ArticlesFeature Articles

    Risk Management for Medical Devices - A Practical Approach

    Imagine yourself in this situation: you just started working for a new company and you review the risk management file you need to include in the next device submission, which, by the way, is urgent. You have a look at the Design History File (DHF). There is an FMEA you hope is up-to-date; a risk management plan that unfortunately lacks typical deliverables and a method for systematically tying together risks, hazards, requirements, controls, verification and validation ...
  • ISO Releases New Device Standard for Toothbrushes

    The International Organization for Standardization (ISO) has released a new standard for a common medical device: the toothbrush. In ISO 20126:2012, Dentistry-Manual Toothbrushes-General Requirements and Test Methods , the organization outlines "pass-fail criteria, physical inspection guidelines, fatigue resistance, chemical challenge and handle strength requirements and tests, as well as marking, labeling and packaging guidelines for manual toothbrushes." "[C]omm...
  • What's in a Frame? ISO Releases New Standard for Glasses Frames

    The International Standards Organization (ISO) released a new standard for glasses frames, saying a new standard was needed to "ensure that glasses manufactured everywhere in the world are safe to use" and adhere to "fundamental requirements." ISO's standard, ISO 12870:2012,  Ophthalmic optics - Spectacle frames - Requirements and test methods , includes outlined requirements for: physiological compatibility measurement dimensional tolerances tolerance on scr...
  • CDRH Releases New Learning Module on ISO 13485:2003

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released a new set of learning modules Friday on voluntary audit report submissions and how to utilize CDRH's new pilot program . The learning section consists of an introductory video and five learning modules in both English and French. The modules cover the following topics: GD211 - Welcome and Introduction by Dr. Jeff Shuren and Dr. Surpriya Sharma GD211 - Module 1...
  • TGA: PIP Implants in Australia not Likely to Rupture

    The Australian Therapeutic Goods Administration (TGA) today released statements indicating that, "there is no evidence of an increased rupture rate for PIP [Poly Implant Prothese] silicone gel breast implants used in Australia." TGA indicated that they have received 37 reports of PIP implant ruptures (.4%), which is in line with the expected rupture rate of all implants (1% per year). Approximately 8,900 Australian women have the implants. TGA had already recalle...