The Medical Device Authority (MDA) of Malaysia has released Guidance Document MDA/GD/0066, First Edition, titled “Importation of Medical Device for Personal Use”, to support the industry and healthcare professionals in their efforts to comply with the Medical Device Act (Act 737) and its associated regulations. This guidance serves as a
On 24th January 2024, the Health Sciences Authority (HSA) of Singapore issued Revision 10 of the “GN-15 Guidance on Medical Device Product Registration”. The highlighted key update, especially for the evaluation routes of Immediate Class B Registration (IBR condition 1) and Expedited Class C Registration (ECR-1), is as follows: Removal of
The Ministry of Public Health (MOPH) of Thailand issued a draft guidance on the Temporary Storage of Medical Devices Outside the Location Specified in the Establishment Registration Certificate, Licenses, Notification Licenses, and Listing Certificates. The key points of the draft guidance are as follows: 1. Storage of medical devices outside
The Ministry of Public Health (MOPH) issued a draft announcement pertaining to the criterions, procedures, and conditions for selling of medical devices in the Thai market. The following are the key points from the draft announcement: Certain medical devices must only be sold to consumers who have obtained a prescription
The Ministry of Public Health (MOPH) of Thailand issued a draft announcement for the production or sale of medical devices exempted under section 27 (2), (3), and (4), with key points as follows: A. Requirements for production of medical devices for sterilization in hospitals: 1. Sterilization Area: Three designated areas:
The Ministry of Public Health (MOPH) of Thailand issued a draft announcement to specify medical devices that are prohibited from direct selling or direct marketing businesses under the Direct Selling and Direct Marketing Act. The list of medical devices included in this draft announcement is as follows: Ophthalmic Viscosurgical Device
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