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  • Regulatory NewsRegulatory News

    Brazil Harmonizes Device Clinical Testing Requirements with International Standards

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. ANVISA, Brazil’s medical device market regulatory agency, has published new requirements for conducting clinical testing of devices in the country. The new regulation,  RDC 10/2015  ( link in Portuguese ), establishes procedures and processes required to perform clinical testing, and also introduces clinical testing petitions that will ne...
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    New Health Canada Rules Cover Single-Use Reprocessed Devices

    Content provided by  Emergo , a medical deviceregulatory affairs and quality assurance consulting firm with offices worldwide. Canadian medical device market regulator Health Canada will begin requiring all reprocessed single-use medical devices to follow Canadian Medical Device Regulations (CMDR) by 1 September 2016. According to Canadian medical technology trade group MEDEC, the new  requirement  will apply to all commercially reprocessed single-use devices, but...
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    New Guidance Clarifies Saudi Labeling Requirements for Medical Devices

    Content provided by  Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Saudi Food & Drug Authority (SFDA) has issued new guidance on labeling requirements for medical devices approved for sale in the Kingdom of Saudi Arabia (KSA). The guidance  clarifies labeling rules previously included in the Saudi Medical Devices Interim Regulation more so than adds any new or altered requirements. Among the key clarifi...
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    New User Fees Set for Foreign Medical Device Manufacturers in China

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Chinese medical device market regulator China Food and Drug Administration (CFDA) has published a draft table of user fees for medical device registrants, and is expected to begin enforcing fee requirements in March 2015. CFDA registration fees will not be insubstantial: Imported Class II device registrants will be charged about $34,000 f...
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    Key Changes to South Korean KGMP, IVD Regulations Set for 2015

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. South Korean medical device regulators will implement significant changes affecting compliance requirements for  in vitro  diagnostic (IVD) registration as well as for Korean Good Manufacturing Practice (KGMP) audits over the course of 2015. According to Emergo consultants in Seoul, officials at the South Korean Ministry for Food and Drug...
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    Mexico's COFEPRIS Exempts Hundreds of Devices from Registration Requirements

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Mexican regulators have expanded their list of healthcare products that do not require registration and approval to be sold in the country. COFEPRIS, Mexico’s medical device market regulator, added 573 items to its  list of products  (link in Spanish) not considered medical devices, effectively removing registration as a requirement for i...
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    Potential Medical Device Regulatory Changes Coming to India in 2015

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. India’s health ministry, the Department of Health and Family Welfare, will submit proposed changes to the country’s medical device and pharmaceutical laws to Parliament in 2015. The proposed  Drugs and Cosmetics (Amendment) Bill , 2015  would adopt definitions of medical devices as well as in vitro diagnostic (IVD) products more in...
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    South Korean Medical Device Regulators Ban Some Raw Materials

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. South Korea’s Ministry of Food and Drug Safety (MFDS) identified certain raw materials prohibited from use in medical device production. According to  Article 5 of the amended MFDS regulation , the following materials may no longer be used in the production of medical devices: Mercury, except in devices used for dental application...
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    ANVISA to Allow Medical Device Firms to Evaluate Their Inspections

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Brazilian medical device regulator ANVISA has begun accepting  feedback  from medical device companies subject to quality management inspections in order to improve and standardize inspection processes. Firms inspected for Brazilian Good Manufacturing Practice (BGMP) compliance now have the option of submitting a form to ANVISA prov...
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    New Electronic Formatting Requirements in Canada for Class III and IV MDL Applications

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Health Canada, Canada’s medical device market regulator, has published new  guidance  requiring electronic formatting for most higher-risk Class III and IV Medical Device License (MDL) applications. Set to take effect 1 December 2014, the new rules will require Class III and IV MDL applicants to submit premarket review documentation...
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    Major Changes to Medical Device Registration Process in Japan

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Revised medical device registration and approval requirements in Japan will become law 25 November 2014 and will impact several compliance areas for foreign manufactures active in the market, according to Emergo’s Tokyo office. Replacing the Pharmaceutical Affairs Law (PAL), the Pharmaceutical and Medical Device Law (PMDL) will ...
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    FDA Announces Major Regulatory Changes, With Specialization a Key Focus

    Regulatory functions at the US Food and Drug Administration (FDA) are set to undergo a major overhaul in the coming months after a year-long effort by the agency recommended making scores of improvements to the way the agency is structured and regulates products. Background In September 2013, FDA announced to internal staff that, in response to "unparalleled challenges" posed by advances in product complexity and globalization, FDA would be forming a new "Program Alignm...