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  • 2017 Industry Outlook: Medical Device Companies Report Robust 2016 Sales
  • EMERGO SUMMARY OF KEY POINTS: A third of all medical device companies taking part in Emergo’s 2017 Global Medical Device Industry Outlook survey reported sales increases of 10% or higher for 2016. Smaller firms with fewer employees and lower operating margins were more likely to report sales of 15% or more. Larger firms with higher operating margins and exposure to more markets with challenging conditions were more likely to report lower sales increases.
    Monday, February 20, 2017

  • Brazil’s ANVISA Developing Regulations for Custom-made Medical Devices
  • EMERGO SUMMARY OF KEY POINTS: Brazilian medical device regulator ANVISA has approved a proposal to create a new regulation specifically addressing 3D and custom-made medical devices and technologies. Use of 3D printers to produce custom-made devices is increasing in Brazil, but no regulations targeting these products yet exists in the country.
    Thursday, February 16, 2017

  • Chinese Regulators Amend IVD Classification Requirements
  • EMERGO SUMMARY OF KEY POINTS: The China FDA has modified its classification requirements for IVD devices with immediate effect. The rule changes are intended to provide more maneuverability to the CFDA in terms of overseeing IVD safety in China.
    Wednesday, February 15, 2017

  • 2017 Outlook: Medical Device Companies See Better Growth Prospects in US, Europe
  • EMERGO SUMMARY OF KEY POINTS: Emergo 2017 Industry Outlook survey respondents expect better sales prospects in the US and Europe than in developing markets. Fewer 2017 survey respondents expect high growth in Brazil, China and India than they did in 2016. Issues including economic and political uncertainty and regulatory compliance help explain why medical device firms are more bearish toward BRIC markets for 2017.
    Monday, February 13, 2017

  • Revisions to Mexico’s Medical Device Regulations under Consideration for 2018
  • EMERGO SUMMARY OF KEY POINTS: Mexican regulators have proposed changes to classification, grouping and other processes for medical devices requiring COFEPRIS registration. Changes would take effect in January 2018 at the earliest. All changes must be published in Mexico’s Official Diary before full implementation.
    Friday, February 10, 2017

  • China FDA Updates Medical Device Recall Process
  • EMERGO SUMMARY OF KEY POINTS: The China Food and Drug Administration (CFDA) has replaced a pilot medical device recall system with a permanent process, Order No. 29. The definition of “defective medical device” has been expanded under the new recall program. The new program will go into effect May 1, 2017.
    Thursday, February 09, 2017

  • First Take: New Indian Medical Device Regulations
  • EMERGO SUMMARY OF KEY POINTS: India’s new Medical Device Rules 2017 will introduce more formalized registration requirements compared to the country’s current system. The new rules include risk-based classification, unique identification requirements and manufacturing quality audits by Notified Bodies. Companies with devices currently registered for sale in India can anticipate a transition period in order to comply with the new rules following their 2018 implementation.
    Monday, February 06, 2017

  • Brazilian Regulators Officially Adjust Medical Device Fees Downward
  • EMERGO SUMMARY OF KEY POINTS: Brazilian regulators have officially revoked medical device registration and quality system inspection fee increases pushed through in late 2015. Under Ordinance 45/2017, ANVISA registrants that paid higher fees will soon be eligible to file for partial refunds. Registrants that avoided higher fees via an ABIMED lawsuit will not qualify for refund requests, however.
    Monday, February 06, 2017

  • In Brief: Brazil Adds Two More Firms to MDSAP Medical Device Quality Inspection Program
  • EMERGO SUMMARY OF KEY POINTS: ANVISA has accredited two more organizations to perform BGMP quality system inspections under the Medical Device Single Audit Program (MDSAP). MDSAP was scheduled to shift from its pilot phase to full implementation by regulators in the US, Brazil, Canada, Australia and Japan in early 2017.
    Friday, February 03, 2017

  • Indian Regulators Publish New Medical Device Rules
  • EMERGO SUMMARY OF KEY POINTS: The Indian government has published new medical device and IVD regulations to replace the country’s Drugs and Cosmetics Act. The new rules will go into effect January 1, 2018.
    Thursday, February 02, 2017

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