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market access Product Safety REACH And The Value Of The Impact Analysis Authored by geoffrey Bock, (Detroit, MI) RoHS/Weee Manager The EU has implemented a new chemicals regulation called REACH, which stands for Regulation, Evaluation, Authorization, and restriction of CHemical substances. The new regulation is replacing over 40 pieces of existing legislation. Manufacturers, importers and users will now have the responsibility of managing the risks posed by chemicals. REACH will be coordinated and implemented by the European Chemicals Agency (ECHA) located in Finland. Manufacturers and importers, up and down the supply chain will be responsible for registering chemicals. Chemicals in preparations or articles manufactured or imported in excess of 1 ton will be required to register. What does this mean for non-european producers? Businesses can be adversely impacted by REACH; supply chains can be disrupted and you can lose market access in the EU. Companies that understand the business implications and impacts of REACH, and develop strategic action plans, will gain a competitive edge over those that fail to do so. Pre-registration will apply to phase-in substances. There will be a 6-month window from June 1, 2008 to november 30, 2008. Failure to pre-register will result in a loss of pre-registration phase-in status; which will result in a full 12 month registration process. What tÜvrheinland ® can do for you: • Comprehensive REACH analysis regarding manufacturer’s products and how they are impacted by the current legislation JulY/08/aug • On-site educational session • Review of sales channel and products • Recommendations of supply channels • Collection of course data required for preregistration • Written list of responsibilities for each chemical • Written list of responsibilities for client • Profile of timelines and deadlines of requirements pertaining to each chemical • Recommended approach of terms and conditions of sale • Pre-registration prepared for each chemical with the EU Chemical Agency • 3 months of on-call monthly consulting from project start • Q&A support from experts in global environmental requirements how you can benefit from tÜvrheinland ® services: • Expertise on EU legislation and REACH implementation • Avoiding withdrawal of product constituents due to lack of fulfilling registration requirements • Receive an Impact Analysis of your business situation and learn how to reduce effort and costs For more information, please call 1-tUv-rheinlanD (1-888-743-4652).
market access Medical Update on FDA’s Third Party Inspection Program and pMAP Authored by gregor Dzialas, (Boxborough, MA) Third party Inspection program Manager The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) introduced the Inspection by Accredited Person Program. Under this program eligible manufacturers of class II and III medical devices can choose to use an FDA accredited third party, such as TüVRheinland ® of north America, to perform inspections to US regulations as an alternative to the traditional inspection by an FDA official. The primary benefit for manufacturers to participate in this voluntary program is to combine FDA inspections with other conformity assessment inspections, e.g. MDD/ ISO 13485/CMDCAS, which will save time, money and resources. The MDUFMA of 2002 established a new subsection of the US Food, Drug and Cosmetic Act, which required FDA to accredit third parties to perform inspections of ConTInUeD on pAge 10 JulY/08/aug eligible device manufacturers. The program is referred to as “Inspection by Accredited Person Program” or “Third Party Inspection Program”. An Accredited Person (AP) under the provisions of this Program is a third party recognized by FDA to: • Assess the quality system of eligible manufacturers of Class II and III devices under 21 CFR Part 820 • Determine compliance with other device requirements in the act and regulations • Prepare and submit reports to FDA, who makes the final compliance assessment By statute the FDA has the mandate to inspect class II and III device manufacturers every two years. Due to FDA’s limited resources and the global expansion of the medical device industry, actual inspection frequency (especially for lower risk device manufacturers and foreign manufacturers) is much lower than the biennial inspection requirement. In a report issued by the US Government Accountability Office (GAO) in January 2008, it is stated that the FDA estimates that establishments for medium risk devices have been inspected every 5 years and foreign establishments involved with medium risk devices every 27 years. The AP inspection program will allow the FDA to focus on higher-risk inspections, and those inspections which are not within the scope of the program, such as “forcause”, PMA and bioresearch monitoring inspections. Conversely, manufacturers with a global marketing presence have been faced with ever increasing number of regulatory requirements and conformity assessments. To maintain their market presence, they must undergo numerous separate inspections each
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