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Regulatory Affairs Update: Philippines

Philippines: Extension of the Regulatory Flexibility for Class B, C, and D Medical Devices that are not Included in the List of Registrable Medical Devices Based on FDA Circular No. 2020-001-A

During the harmonization to ASEAN requirements, the Philippines Food and Drug Administration (PFDA) aims to prevent a negative impact on the supply of medical devices by issuing past provisions FC No. 2021-002A, FC No. 2021-002B, and FC No. 2021-002C (valid until Mar 31, 2024) which provide regulatory flexibility to all Class B, C, and D […]

Philippines: Extension of the Regulatory Flexibility for Class B, C, and D Medical Devices that are not Included in the List of Registrable Medical Devices Based on FDA Circular No. 2020-001-A Read More »

Regulatory Affairs Update: Vietnam

Vietnam: Decision on the Criteria and Principles for the ASEAN CSDT Assessment of Non-In Vitro and In-Vitro Medical Devices

In the first quarter of 2024, The Department of Infrastructure and Medical Equipment released Decision No. 166/QĐ-BYT and Decision No. 490 / QĐ-BYT regarding the issuance of criteria and principles for assessment of the general technical documentation for Non-In Vitro and In-Vitro Medical Devices following ASEAN regulations (CSDT). They have provided the principles for evaluating

Vietnam: Decision on the Criteria and Principles for the ASEAN CSDT Assessment of Non-In Vitro and In-Vitro Medical Devices Read More »

Regulatory Affairs Update: Indonesia

Indonesia: Listing Product Schedule Update in the Ministry of Health e-Catalogue

The Procurement Goods/Services (LKPP: Lembaga Kebijakan Pengadaan Barang dan Jasa Pemerintah) under the Indonesia Ministry of Health announces the updated timeline for the e-Catalogue listing has been extended until 30 June 2024. Stakeholders can still list their products in the e-Catalogue during the timeline announced until further notice. With regard to Freeze and Unfreeze regulated

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Andaman Medical Regulatory Affairs Update

Philippines: Deletion Of COVID-19 Medicines And Devices From The List Of VAT-Exempted Health Products

The Philippines Food and Drug Administration (FDA) issued an Advisory No. 2024-0498 dated 06 March 2024, entitled “Delisting of COVID-19 Medicines and Devices from the List of VAT-Exempt Health Products”, informing the stakeholders and all concerned clients that the products used for COVID-19 shall no longer be VAT-Exempted, effective 01 January 2024. This action is

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Andaman Medical Regulatory Affairs Update Singapore

Singapore: HSA Regulations Alignment Related With Software / Programmed or Programmable Medical Device

The Health Sciences Authority (HSA) of Singapore made several key updates to align with current International Medical Device Regulators Forum (IMDRF) regulatory recommendations regarding software/programmed or programmable medical devices. Product owners that are involved in Software as a Medical Device (SaMD) either being standalone or embedded within the Medical Device are highly suggested to be

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Regulatory Affairs Update Indonesia

Indonesia: Announcement of the Listing Product Schedule Update in e-Catalogue Ministry of Health

As of December 2023, the Policy Institute for Procurement Goods/Services (Lembaga Kebijakan Pengadaan Barang dan Jasa Pemerintah (LKPP)) under Ministry of Health (MOH) Indonesia has announced the schedule of Product Listing in e-Catalogue system for Health Facility in Indonesia is open until 31 March 2024 or until further notice. For stakeholders who plan to list

Indonesia: Announcement of the Listing Product Schedule Update in e-Catalogue Ministry of Health Read More »

Regulatory Affairs Update Philippines

Philippines: FDA Released Draft Regulation on the Guideline Prescribing the Rules, Requirements and Procedures in the Application for LTO of Covered Health Product Establishments

To further develop the Philippines Food and Drug Administration’s (FDA) processes and automation of their system for initial, renewal and variation applications for the License to Operate (LTO) through the FDA eServices Portal System, the FDA proposed revisions on the documentary and other technical requirements for LTO applications to be abreast with internationally acceptable standards.

Philippines: FDA Released Draft Regulation on the Guideline Prescribing the Rules, Requirements and Procedures in the Application for LTO of Covered Health Product Establishments Read More »

Andaman Medical Regulatory Affairs Update Malaysia

Malaysia: Draft Guidance Document: Placement of HIV Self-Test (HIVST) Kit in Malaysia Market

On February 19, 2024, the Medical Device Authority (MDA) of Malaysia released a draft guidance regarding the Placement of HIV Self-Test (HIVST) Kit in the Malaysian market. This guidance, identified as MDA/GD/0065, aims to provide direction for businesses interested in importing, exporting, or placing the Human Immunodeficiency Virus Self-Test kit (HIVST) in Malaysia. This document,

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Andaman Medical Regulatory Affairs Update Philippines

Philippines: PFDA Released Draft Regulation on Extension of Regulatory Flexibility for Non-Registrable Class B, C and D Medical Devices

During the harmonization to ASEAN requirements, PFDA aims to prevent a negative impact on the supply of medical devices by issuing past provisions FC No. 2021-002A, FC No. 2021-002B, and FC No. 2021-002C (valid until Mar 31, 2024) which provide regulatory flexibility to all Class B, C, and D medical devices that are not included

Philippines: PFDA Released Draft Regulation on Extension of Regulatory Flexibility for Non-Registrable Class B, C and D Medical Devices Read More »

Andaman Medical Regulatory Affairs Update Vietnam

Vietnam: Amendment and Supplementation of Several Articles of Decree 96/2023/NĐ-CP Regarding Medical Device Management

On 30 December 2023, the Authority of Vietnam issued Decree 96/2023/NĐ-CP detailing several articles of the Law on Medical Examination and Treatment. Furthermore, Article 147 of this Decree has amended and supplemented some articles of Decree 98/2021/NĐ-CP regarding “Medical Device Management.” The highlighted amendments and supplementations to the articles of Decree 98/2021/ND-CP are as follows:

Vietnam: Amendment and Supplementation of Several Articles of Decree 96/2023/NĐ-CP Regarding Medical Device Management Read More »

Andaman Medical Regulatory Affairs Update Malaysia

Malaysia: MDA Releases Guidance Document MDA/GD/0067: Enhancing Post Market Information Exchange for ASEAN Member States

The Medical Device Authority (MDA) has released Guidance Document MDA/GD/0067, First Edition, titled “Post Market Information Exchange for ASEAN Member States“, to assist the industry and healthcare professionals in complying with the Medical Device Act (Act 737) and its associated regulations. The development of the Guideline on Medical Device Post Market Information Exchange for ASEAN

Malaysia: MDA Releases Guidance Document MDA/GD/0067: Enhancing Post Market Information Exchange for ASEAN Member States Read More »

Malaysia: MDA Released Guidance Document MDA/GD/0066: Importation of Medical Device for Personal Use

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 comprehensive resource for individuals intending

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Andaman Regulatory Affairs Update Singapore

Singapore: New Revision of the Medical Devices Product Classification Guide

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 marketing history in Singapore as

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Regulatory Affairs Update Thailand

Thailand: Draft Guidance on the Temporary Storage of Medical Devices Outside Its Specified Location in the Certificate or License

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

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Andaman Regulatory Affairs Update Thailand

Thailand: Draft for the Announcement of Requirements for Selling of Medical Devices

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

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Regulatory Affairs Update Thailand

Thailand: Draft Announcement for the Production or Sale of Medical Devices Exempted under Section 27 (2) (3) and (4)

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

Thailand: Draft Announcement for the Production or Sale of Medical Devices Exempted under Section 27 (2) (3) and (4) Read More »

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

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

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

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

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 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

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

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

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

Person undergoing radiation therapy

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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Two female office professionals at a computer

Malaysia: MDA Issued Two Updated Guidance Documents on Harmonised Classification and Borderline Products in ASEAN 

On December 12th, 2023, the MDA issued 2 (two) guidance documents as follows: MDA/GD/0062 Harmonised Classification of Medical Devices in ASEAN, Second Edition. MDA/GD/0063 Harmonised Borderline Products in ASEAN, Second Edition. These are the highlights of each regulation: Harmonised Classification of Medical Devices in ASEAN 2nd Edition (MDA/GD/0062) Harmonised Borderline Products in ASEAN 2nd Edition

Malaysia: MDA Issued Two Updated Guidance Documents on Harmonised Classification and Borderline Products in ASEAN  Read More »

Scientist working in laboratory

Indonesia: List Of SNI ISO/IEC 17025:2017 Accredited Testing Laboratories For Medical Devices And Household Supplies In Indonesia

On 5 December 2023, the General Director of Pharmaceuticals and Medical Devices of the Ministry of Health (MoH) of Indonesia released a circulation letter No: HK.02.02/E/2379/2023 regarding the List of SNI ISO/IEC 17025:2017 Accredited Testing Laboratories for Medical Devices and Household Supplies. SNI itself is an abbreviation of Standar Nasional Indonesia or Indonesian National Standards.

Indonesia: List Of SNI ISO/IEC 17025:2017 Accredited Testing Laboratories For Medical Devices And Household Supplies In Indonesia Read More »

Person tapping on a padlock icon

Indonesia: Temporary Closing of the Online System for Submission of Medical Devices and Household Supplies Registration, Online Certificates, and Distribution License by the Ministry of Health of Indonesia

On 5 December 2023, the Ministry of Health (MoH) of Indonesia released an announcement letter No: FR.03.01/E.V/2510/2023 regarding the maintenance process of the MoH platform for online licensing system of medical devices and household supplies registration, issuance of online certificates, and issuance of medical devices distribution license (IDAK). Therefore, the following changes will be applied:A.

Indonesia: Temporary Closing of the Online System for Submission of Medical Devices and Household Supplies Registration, Online Certificates, and Distribution License by the Ministry of Health of Indonesia Read More »

Two scientists wearing PPE

Indonesia: Procedure for the Implementation of Foreign Halal Certificate Registration by The Halal Product Guarantee Administering Agency (BPJPH) in Indonesia

Based on Law No. 33 of 2014 regarding Halal Product Guarantee, all foreign halal products imported into Indonesia do not require to apply for a local halal certificate, if the foreign halal certificate is issued by a foreign halal institution that has collaborated on mutual recognition of halal certificates with The Halal Product Guarantee Administering

Indonesia: Procedure for the Implementation of Foreign Halal Certificate Registration by The Halal Product Guarantee Administering Agency (BPJPH) in Indonesia Read More »

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