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The Ministry of Public Health (MOPH) of Thailand issued a draft guidance on the Temporary Storage of Medical Devices Outside the Location Specified in the Establishment Registration Certificate, Licenses, Notification Licenses, and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 The key points of the draft guidance are as follows: 1.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 its specified location as mentioned

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 from a healthcare professional. The

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: Dirty Zone (used equipment), Clean

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 (OVD) Teeth whitening products HIV

The secretary of the Thailand Food and Drug Administration (TFDA) issued a draft announcement as per the statement mentioned in section 21, paragraph 3 of the Medical Devices Act B.E. 2551, regarding notification of possession, movement, inspection of readiness, and costs of medical devices that require technology assessment. This announcement does not apply to the

Thailand FDA released several announcements related with the medical devices, as follows: 1. Deadline for submitting documents in Full CSDT As of 15 February 2024 onwards, anyone who wishes to submit license applications (for Class 4 or Class D) or notification applications (for Class 2 & 3 or Class B & C)  to produce or

The Ministry of Public Health (MOPH) of Thailand issued a draft guidance specifying information that should be displayed on a sign at the production, import, or sale site of certain types of medical devices. It is mentioned in the draft guidance that the sign shall include: The name and surname of the production, import, or

The Ministry of Public Health (MOPH) in Thailand issued a draft guidance specifying on three types of medical devices that require a production, import, or sale controller, such as: Viscous products for use in eye surgery Silicone breast implants for implantation in the body Hyaluronic acid injections for the correction of skin defects The draft

To ensure the standardized quality, efficiency, and safety of importing or selling medical devices, which is in the interest of consumer protection, it is appropriate to establish a Quality Management System for Importing or Selling Medical Devices. This announcement shall become effective after 1 year from the date of publication in the Royal Gazette. The

The Ministry of Public Health (MOPH) in Thailand issued a draft guidance on criterions, procedures, and conditions for the production of medical devices that are exempt under Section 27(8) B.E. 2008. The key points of the draft guidance are as follows: 1. Production of medical devices by a government agency for testing and calibrating medical