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Malaysia’s Medical Device Authority (MDA) has established an expedited review process for medical devices already approved in other jurisdictions including the U.S., Canada, Australia, the EU, and Japan. Read More
The FDA finalized guidance on GMP requirements for combination product manufacturers, adding scenarios to clarify how to comply with certain device requirements. Read More
For products that include a device component, sponsors must submit five-day reports, with supplemental or follow-up reports; malfunction reports; and correction or removal reports, as well as comply with recordkeeping requirements. Read More