January 2024

Andaman Regulatory Creative - Thailand

Thailand: Draft Announcement on Prohibition of Direct Selling or Direct Marketing of Certain Medical Devices in Thailand

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 […]

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Regulatory Affairs Update; Thailand

Thailand: Draft Announcement on Notification of Possession, Movement, Inspection of Readiness, and Costs of Medical Devices that Require Technology Assessment

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

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Regulatory affairs update Vietnam

Vietnam: Inspection And Review Of The Declaration Of The Applicable Standard Procedure In Vietnam

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

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Regulatory affairs update: Philippines

Philippines: Revised Process Of CMDR / CMDN Initial And Renewal Application

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

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Regulatory affairs update Thailand

Thailand: Announcement From Thailand FDA Regarding CSDT Applications, Annual Report Submission And Breathalyzers

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

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Regulatory Affairs Update Vietnam

Vietnam: Ministry Of Health Appoints The Units To Appraise The Common Submission Dossier Template (CSDT) According To ASEAN Regulations

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

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Regulatory Affairs Update: Philippines

Philippines: PFDA Released Draft Guidelines On The Recall Of Health Products

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

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Thailand: Draft Guidance for Sign Displaying the Name and Qualifications of the Production, Import and Sale Controller of Medical Devices

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

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Thailand: Draft Guidance of Medical Devices Requiring a Production, Import, or Sale Controller

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

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Thailand landscape with flag

Thailand: Announcement of the Timelines for the Implementation Quality System for Importing or Selling of Medical Devices B.E.2566 (2023) in Thailand

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

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Thailand landscape with flag

Thailand: Draft Guidance for the Production of Medical Devices that are Exempted under Section 27(8) B.E. 2008 in Thailand

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

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Vietnam landscape with flag

Vietnam: Temporary Freezing of the Online System for Submission of Class C and D Medical Devices by the Ministry of Health

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

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Singapore: Announcement on the List of Regulatory Fee Revision for Health Products

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

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Philippines: PFDA Announced Accredited Technical Service Providers for Radiation Dosimetry of Individual Monitoring

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

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Singapore: HSA Warns On Cybersecurity Vulnerabilities Potentially Affecting Medical Devices Using 5G Modems

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

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application in scrabble letters

Philippines: FDA Announces Application Holiday for Certificate of Medical Device Notification (CMDN) Applications

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,

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Malaysia: Updated Information on the Surveillance Report of Implantable Medical Devices in Malaysia

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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