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Regulatory Affairs Update: Indonesia

Indonesia: Issuance of Regulation governing the Overseas Testing Centre for Certification Purposes of Telecommunication Device and/or Equipment

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Decree No. 109 of the Year 2024 concerning the Determination of an Overseas Testing Centre for Certification Purposes of Telecommunication Devices and/or Equipment was issued by the Director General of Resources Management and Equipment of Posts and Informatics under the Ministry of Communications and Informatics. According to the regulation, the test Report from Overseas could […]

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Regulatory affairs update: Singapore

Singapore: Consultation on draft of Guidance on Change Management Program (CMP) for SaMD

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The Health Sciences Authority (HSA) Singapore has initiated a new optional regulatory pathway – Change Management Program (CMP), specifically for SaMD that is incorporated into HSA’s Premarket Product Registration and Change Notification (CN) processes. CMP’s eligibility requires mandatory and valid conformance to latest standards of ISO 13485 and IEC 62304 throughout SaMD total product lifecycle

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Regulatory affairs update: Thailand

Thailand: Thai FDA Shares Criteria, Methods and Conditions for Issuing Licenses and Medical Device Advertising License 2021 (B.E. 2564)

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Medical Device Control Division would like to inform entrepreneurs to follow the guidelines for displaying warnings, prohibitions, and precautions in advertising medical devices in accordance with the Thai FDA announcement. The criteria, methods and conditions for issuing licenses and medical device advertising license 2021 (B.E. 2564), with details according to the manual for requesting permission

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Regulatory Affairs Update: Thailand

Thailand: Thai FDA Shares Information for Prohibitions and Prohibited Messages in Advertising Medical Devices

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On  August 27, 2024, Thailand FDA published an infographic about Medical Device Advertisement on their official Facebook page.  Here are some examples of “text, images, or advertising” that are “not allowed” in advertising medical devices: Using words or statements about the benefits, quality, quantity, standards, ingredients, or origin of medical devices in an exaggerated manner,

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Regulatory Affairs Update: Malaysia

Malaysia: MDA’s Approach to Expired EC Certificates and Self-Declared for New Registration and Re-Registration of Class B IVD Medical Devices

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The Medical Device Authority of Malaysia (MDA) has announced that expired EC Certificates under certain EU Directives (90/385/EEC, 93/42/EEC, 98/79/EC) or declarations of conformity for Class B IVD devices under Directive 98/79/EC can be used for conformity assessment by registered conformity assessment bodies (CABs). This approach addresses delays in transitioning to the EU MDR and

Malaysia: MDA’s Approach to Expired EC Certificates and Self-Declared for New Registration and Re-Registration of Class B IVD Medical Devices Read More »

Andaman Medical Indonesia Celebrates Independence Day with Enthusiasm and Team Spirit

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Last week, Andaman Medical’s Indonesian team came together to celebrate a significant milestone in the nation’s history—Indonesia’s Independence Day. The 17th of August is more than just a date on the calendar; it’s a day that commemorates the hard-won freedom of the Indonesian people, and this year, our team honoured it with a celebration full

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Regulatory Affairs Update: Vietnam

Vietnam: Announcement Regarding the Update of Documents on the DMEC System

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On August 16, 2024, the Department of Medical Infrastructure and Equipment issued an announcement to registration facilities regarding the update of documents on the DMEC website. The Department requires registration facilities to follow up the processing progress and update the documents on the system as per the following guidelines: Instructions for updating documents related to

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Regulatory Affairs Update: Thailand

Thailand: FDA Shares Information for the Registration of Monkeypox Diagnostic Test

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On August 20, 2024, Thailand FDA published an infographic about the registration of diagnostic tests for Monkeypox (Mpox) in Thailand. The information shared is as follows: ● Monkeypox Diagnostic Test is categorized as  Medical devices for in vitro diagnostics (IVD) group and classified as Notify medical devices (Class B or C portal). ● Documents for

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Regulatory Affairs Update: Indonesia

Indonesia: Minister of Health Issued a New Regulation Pertaining to Guidelines on Halal Manufacturing Methods for Drugs, Biological Products, and Medical Devices, as well as the Inclusion of Information on the Origin of Ingredients for Medical Devices

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The Minister of Health of Indonesia has established regulation Number 3 of 2024 about Guidelines on Halal Manufacturing Methods for Drugs, Biological Products, and Medical Devices, as well as The Inclusion of Information on The Origin of Materials for Medical Devices on 5th March 2024 and stipulated on 2nd April 2024. To ensure the achievement

Indonesia: Minister of Health Issued a New Regulation Pertaining to Guidelines on Halal Manufacturing Methods for Drugs, Biological Products, and Medical Devices, as well as the Inclusion of Information on the Origin of Ingredients for Medical Devices Read More »

Regulatory Affairs Update: Philippines

Philippines: PFDA Shares the Guidelines for the Pilot Implementation of the FDA eServices Portal System for the Initial Application of CMDN within the National Capital Region (NCR)

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On August 2, 2024, the Food and Drug Administration (FDA) released an advisory regarding the implementation guidelines for a platform for submitting CMDN applications. FDA is currently developing the FDA eService’s Portal System – an online platform for a streamlined initial application of a Certificate of Medical Device Notification (CMDN). As part of this plan,

Philippines: PFDA Shares the Guidelines for the Pilot Implementation of the FDA eServices Portal System for the Initial Application of CMDN within the National Capital Region (NCR) Read More »

Regulatory Affairs Update: Vietnam

Vietnam: Promulgation of Guidelines for the Evaluation of Legal Documents for Registration Dossiers of Medical Device Class C & D

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On August 5th 2024, the Vietnam Ministry of Health (MoH) issued Decision No. 2302/QD-BYT regarding the promulgation of Guidelines for the Evaluation of Legal Documents for Registration Dossiers of Medical Device Class C and D. This decision replaces Decision No. 3007/QĐ-BYT dated November 3, 2022. There are no changes to the legal documentation component for

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Regulatory Compliance and Market Credibility

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Registering your IVD device with the Thai Food and Drug Administration (Thai FDA) ensures compliance with local regulations, enhancing your product’s credibility and acceptance in the market. Compliance with stringent regulatory standards demonstrates your commitment to safety, efficacy, and quality, which can significantly boost your reputation among healthcare providers.

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