Malaysia Medical Device Authority

Malaysian Regulators Push Back Medical Device Labeling Requirement Deadline

EMERGO SUMMARY OF KEY POINTS:

  • The Malaysian MDA is extending medical device labeling compliance deadlines by three years.
  • The extended transition period is intended to allow Malaysian market registrants enough time to ensure compliance.

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.

Malaysian Advertising Rules for Medical Devices Published

The Malaysian Medical Device Authority (MDA) has issued draft requirements for how to properly market and advertise medical devices in the country.

Malaysian Fast-track Registration Pathway Unveiled

Medical device market regulators in Malaysia have set rules for a fast-track registration process available for some medical devices between April 10 and June 30, 2015.

Malaysian Regulators Lay Out Post-Market Surveillance Audit Framework

Malaysia’s Medical Device Authority, responsible for overseeing the country’s medical device market, has published new draft guidance on post-market surveillance regulatory audits for manufacturers authorized to sell their products there.