Japan Blog Posts

Japanese Regulators Raise Medical Device Registration Fees

EMERGO SUMMARY OF KEY POINTS:

  • The Japanese PMDA has increased marketing application review fees for nine medical device categories.
  • The new fees went into effect April 1, 2018.
  • PMDA application review fee increases range from eight to 15%.
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In Brief: US FDA, Brazil ANVISA Expand Lists of Qualified Audit Organizations for MDSAP

EMERGO SUMMARY OF KEY POINTS:

  • US and Brazilian medical device market regulators have updated their lists of organizations authorized to conduct QMS audits under the Medical Device Single Audit Program (MDSAP).
  • There are now four companies recognized as MDSAP auditing organizations and 13 organizations authorized by the US FDA to carry out audits.
  • Brazil’s ANVISA now recognizes nine MDSAP audit organizations.
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Japanese Regulators to Reduce Some QMS Assessment Fees 30% in 2017

EMERGO SUMMARY OF KEY POINTS:

  • Japanese QMS conformity assessment fees for Class II medical devices will be reduced by 30%.
  • The fee reductions take effect in April 2017.
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Japanese Medical Device Premarket Review Timeframes Improving

EMERGO SUMMARY OF KEY POINTS:

  • Japanese Pre-market Approval (PMA) review timeframes have been gradually improving in recent years.
  • A joint effort between Japanese regulators and industry is likely driving this decrease in review times.
  • Faster review timeframes should drive more interest from foreign medical device firms in Japanese market registration, according to Emergo consultants.
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MDSAP Authorities Push for Medical Device Industry Participation

Officials overseeing the Medical Device Single Audit Program (MDSAP) developed to allow single quality system audits across multiple regulatory jurisdictions have issued an official request for participation to medical device manufacturers ahead of the program’s full implementation deadline.

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Japanese MHLW Takes Steps Toward Aligning ISO 13485:2016 with Its Own QMS Requirements

Japan’s Ministry of Health, Labour and Welfare (MHLW) has published an administrative notice on how some of the new ISO 13485:2016 quality system standard for medical devices will be incorporated into the country’s own QMS requirements.

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MDSAP Update: As Pilot Winds Down, Manufacturer Buy-in Still Lacking (Part 2)

In this second part of Emergo's analysis of the Medical Device Single Audit Program (MDSAP), we examine the current status of and challenges to the program as Australian, Brazilian, Canadian, Japanese and US regulators work towards implementation.

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MDSAP Update: As Pilot Winds Down, Manufacturer Buy-in Still Lacking (Part 1)

The pilot for the international Medical Device Single Audit Program (MDSAP) is set to end in December 2016, but challenges including low manufacturer participation levels and lack of coordination among some regulators must still be addressed before full-blown implementation of the program can occur.

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Japan’s Import Notification Requirements for Medical Devices Changing in 2016

Japanese Import Notification requirements currently in place for foreign medical devices and drugs registered for sale in the country expired at the end of 2015, and have been replaced by a new importation system starting January 1, 2016.

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Japan’s PMDA Now Offers Pre-Consultations for Medical Device Registrants

In conjunction with the recent implementation of the Pharmaceutical and Medical Device Act (PMD Act), Japanese regulators have launched a new pre-consultation program to assist registrants as they begin their device certification application processes.

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