Medical Device Authority

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.

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.

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.

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.

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.

Malaysia Update: Labeling, Exemptions, Advertising Rules

Medical device market regulators in Malaysia have recently issued new and updated rules regarding the planned transition to new labeling requirements, as well as clinical research exemptions and advertising rules for devices.

Malaysia’s Medical Device Registration Transition Period Winding Down

The transition period for medical device registrations in Malaysia is coming to a close, after which Malaysian market applicants will have to submit substantially more paperwork to regulators in order to obtain registration.

Malaysian Regulators Exempt Low-risk Medical Devices from Premarket Review

Malaysian medical device regulators have exempted all low-risk Class A medical devices from premarket review requirements, simplifying market access for these products.

Malaysia’s Medical Device Authority Clarifies Declaration of Conformity Rules

New guidance from Malaysian medical device market regulators provides more specifics and clarity regarding Declaration of Conformity (DoC) requirements for registration in the country.

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