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
On 30 December 2023, the Vietnam Ministry of Health (MoH) issued Dispatch 8329/BYT-HTTB to the Local Health Department, requesting for the review on the implementation of the declaration of applicable standards within the area. This is due to the MoH receiving information that manufacturers or importers of medical devices have reduced the classification risk of
The Philippines Food and Drug Administration (FDA) issued an advisory No. 2024-0009, dated 10 January 2024, regarding Revision in the Process of Application for Certificate of Medical Device Registration (CMDR) / Certificate of Medical Device Notification (CMDN), Initial and Renewal. There are a few key points highlighted in the FDA Advisory with regards to the
Philippines: Revised Process Of CMDR / CMDN Initial And Renewal Application Read More »
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
On 02 January 2024, the Vietnam Ministry of Health issued Decision No. 04/QD-BYT which elaborated that the appraisal of the submitted CSDT (Common Submission Dossier Template) for the purpose of medical device registration, will be conducted by the appointed third-party agencies as follows: For non-in vitro medical devices: Institute of Medical Equipment and Construction. For
As part of the larger Post Market Surveillance (PMS) activity in the Philippines, the Food and Drug Administration (FDA) issued a draft on the Guideline for The Recall of Health Products. The main goal of the issuance of this draft guideline is to update the previously issued FDA Circular No. 2016-012. This draft guideline will
Philippines: PFDA Released Draft Guidelines On The Recall Of Health Products Read More »
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
On 31 December 2023, the Ministry of Health (MoH) of Vietnam temporarily froze the online system for the submission of class C and D medical devices. The DMEC website is currently under maintenance starting 01 January 2024 in order to implement the CSDT in accordance with Decree 07/2023/NĐ-CP amending some articles of Decree 98/2021/NĐ-CP dated 08 November
The Health Sciences Authority (HSA) of Singapore announced regulatory fees revision pertaining to health products including medical devices, to be effective on 1 July 2024. The HSA continues to absorb the 1% Goods and Services Tax (GST) increment which was implemented on 1 Jan 2023 and 1 Jan 2024, until further notice. The fee increase
Singapore: Announcement on the List of Regulatory Fee Revision for Health Products Read More »
On December 29, 2023, PFDA issued Circular No. 2023-012, listing Accredited Technical Service Providers for Radiation Dosimetry of Individual Monitoring Services. Aligned with DOH AO No. 2020-0035, PFDA oversees facilities using radiation devices to safeguard workers. Emphasizing adherence, PFDA requires providers to establish formal procedures for approval, recognition, or authorization of individual monitoring and related
On 15 December 2023, Health Sciences Authority (HSA) Singapore issued a medical device advisory to alert industry stakeholders to cybersecurity vulnerabilities known as “5Ghoul”. “5Ghoul” affects commercial off-the-shelf (COTS) edge devices using 5G modems. Medical device systems using 5G modems for internet connectivity to function could be attacked in the form of lost, frozen, or
The Center for Device Regulation, Radiation Health, and Research (CDRRHR) of the Food and Drug Administration (Philippines) have announced that they will be conducting an inventory and processing of the pending applications for registration of medical devices. In line with this, FDA Philippines has declared an application holiday for CMDN applications from December 15, 2023,
On December 14th, 2023, the Medical Device Authority (MDA) of Malaysia issued a requirement for surveillance report on implantable medical devices on the homepage of Medcast 2.0+ system. This requirement applies to distributors in which as per clause 27.(1) until 27.(3) in GDPMD, establishments that distribute implantable medical devices shall submit a surveillance report to
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ANDAMAN MEDICAL PTE LTD (Head Office Singapore)
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