MALAYSIA: MDA Regulatory Updates - Publication of Third Edition Guidance on Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application – April/May 2026

• 2026-05-27 09:53:25

The Medical Device Authority (MDA) has published the latest edition of Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application, MDA/GD/0043, which outlines the eligibility of personnel authorized to apply for the exemptions, specifies the procedures for notification, applicant responsibilities, and use of unregistered medical devices. The document is intended to facilitate timely access to medical devices for specific needs in healthcare settings.

了解更多

PHILIPPINES: Updated Draft Guidelines for Availing Compassionate Special Permit for the Restricted Use of Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices – March/April 2023

• 2023-03-27 08:52:43

PFDA presented a draft of the updated guidelines on obtaining a special permit for restricted use of unregistered drug and medical device products. In addition to previous patient conditions laid out by previous regulations, this new guidance widens the product scope to vaccines and the diseases to include those that may result in the patient's permanent disability.

了解更多