Malaysia Blog Posts

In Brief: Full Enforcement of Malaysian Medical Device Regulations Set for July 1, 2018

EMERGO SUMMARY OF KEY POINTS:

  • Malaysian medical device registration rules will come into full force in July 2018.
  • Companies currently using Acknowledgment Letters to sell their devices in Malaysia will need to obtain full registration by June 30, 2018.
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Malaysian Regulators Extend Moratorium for Medical Device Registrations

EMERGO SUMMARY OF KEY POINTS:

  • The Malaysian MDA will allow qualifying medical device market applicants to sell their products in the country pending full regulatory approval through June 2018.
  • MDA registrants that submitted applications on or before June 30, 2016 qualify for the extended moratorium.
  • Companies that submitted MDA registration applications after June 30, 2016 must obtain full regulatory approval before Malaysian commercialization.
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Compliance Deadlines Approaching for Malaysian Medical Device Registration

EMERGO SUMMARY OF KEY POINTS:

  • Malaysian regulators at the MDA have set two registration-related deadlines for companies whose market applications are still being processed.
  • Late October 2017 and early January 2018 deadlines will impact Malaysian market registrants whose applications are still under regulatory or Conformity Assessment Body review.
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Malaysian MDA Updates Mandatory Problem Reporting Policy for Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • The Malaysian Medical Device Authority has updated its mandatory problem reporting criteria.
  • MDA reporting timeframes have been updated to reflect severity of problems involving medical devices for sale in Malaysia.
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Malaysian Regulators Set Deadlines for Combination Product Regulatory Policy

EMERGO SUMMARY OF KEY POINTS:

  • Malaysian regulators will begin enforcing new combination product registration rules in July 2018.
  • Combination products will have to meet requirements of both the Medical Device Authority (MDA) and the National Pharmaceutical Regulatory Agency (NPRA).
  • Combination products already on the Malaysian market will have to meet new requirements when they renew their registrations.
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Malaysia Update: ASEAN ratification, Medical Device Regulation revisions on the way

EMERGO SUMMARY OF KEY POINTS

  • Malaysia plans to ratify the ASEAN Medical Device Directive (AMDD) in mid-2017.
  • The Malaysian Medical Device Authority (MDA) plans to publish several new guidance documents in the near future.
  • MDA plans to overhaul Malaysia’s medical device regulatory system are underway.
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Malaysian Authorities Publish Medical Device Registration Transfer Policy

EMERGO SUMMARY OF KEY POINTS:

  • The Malaysian MDA has put out new guidance for medical device registration transfers.
  • Registration transfers are only available for devices that have already obtained market authorization from the MDA.
  • Malaysian device registration transfers require cooperation between current and new authorized representatives.
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New Medical Device Classification Criteria from Malaysian MDA

EMERGO SUMMARY OF KEY POINTS:

  • The Malaysian MDA has introduced a formal process to determine whether a health product is considered a medical device.
  • The MDA uses four key criteria, including intended use, to determine if a product should be classified as a device.
  • Companies may submit applications to the MDA to obtain official classification decisions regarding their products.
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Malaysian Regulators Issue New Guidance on Combination Products

EMERGO SUMMARY OF KEY POINTS:

  • Malaysian regulators have proposed a familiar approach for registration of combination products.
  • How a combination product would be regulated in Malaysia would depend on its primary mode of action, according to new guidance.
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