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HSA issues updated guidance on Grouping of Medical Devices for Registration

HSA issues updated guidance on Grouping of Medical Devices for Registration

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The Singapore Health Sciences Authority (HSA) has issued updated Guidance on the Grouping of Medical Devices for Registration (GN12-2 revision 2). This concerns:   Dental Medical Devices of Class B only which wish to apply for registration using dental grouping terms. Applicants may group their dental devices using GN-12-1 or this latest version of the […]

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MDA Guideline on Registration of COVID-19 Test Kits

MDA Guideline on Registration of COVID-19 Test Kits

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The Malaysian Medical Device Authority (MDA) released a new Guideline for the Registration of COVID-19 IVD Test Kits (MD/GL/07) on 24 January 2022. The guideline covers both the registration of COVID-19 test kits for those kits which have previously obtained Special Access Notification or Conditional Approval. It also covers registration for new COVID-19 test kits

MDA Guideline on Registration of COVID-19 Test Kits Read More »

mda announces end special access routes covid19 test kits

Malaysian MDA announces end of Special Access Route for COVID-19 Test Kits

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The Malaysian Medical Devices Authority (MDA) has decided that all COVID-19 test kits whether for professional use or for personal use must be registered under Section 5 of the Medical Devices Act 2012 (Act 737) before being placed on the market. This is effective as of 1 February 2022. This means that as from 31

Malaysian MDA announces end of Special Access Route for COVID-19 Test Kits Read More »

Draft guidelines categorization of borderline health products FDA Philippines

FDA Philippines issues draft guideline on categorization of borderline health products

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The Food and Drug Administration Policy and Planning Service (FDA PPS) of the Philippines has issued draft guidelines for comments and input from industry stakeholders covering the categorization of borderline health products under the jurisdiction of the FDA. The FDA’s jurisdiction covers multiple product categories such as devices, cosmetics, drugs, food, and others. Some health

FDA Philippines issues draft guideline on categorization of borderline health products Read More »

in vitro diagnostic draft regulation fda philippines

FDA Philippines issues draft regulation on IVD market authorizations

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The Food and Drug Administration (FDA) of the Philippines has issued a draft regulation on IVD market authorizations. The draft is open for comments from industry stakeholders until 7 February 2022. Here are the main points of the draft regulation issued by the FDA: New registration, notification and listing certificates specially for In-Vitro Diagnostics will

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Philippines FDA allows registration Covid19 Self Test Kits

Philippines FDA opens registration to COVID19 Self-Test Kits

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The Philippines FDA now accepts applications for registration for COVID 19 Self-Test Kits. The Philippines FDA issued Advisory No. 2021-3604 on 29 December 2021 regarding the start of acceptance of submissions for Special Certification of COVID-19 self-test kits that will be effective as of 6 January 2022, in accordance with the following Memorandums: FDA Memorandum No.

Philippines FDA opens registration to COVID19 Self-Test Kits Read More »

Restrictions online selling optical devices and contact lenses in Malaysia

Restrictions for the selling of Optical Devices and Contact Lenses online in Malaysia

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Restrictions for the selling of optical devices and contact lenses online in Malaysia were announced by the Medical Device Authority (MDA) on 7 January 2022. This announcement prohibits the online sale of optical devices or contact lenses on any e-marketing platform except for websites (managed by Registered Optometry Practitioners) that must meet strict guidelines issued

Restrictions for the selling of Optical Devices and Contact Lenses online in Malaysia Read More »

Covid 19 Test Kit Philippines Validity Extension

COVID-19 Test Kit in the Philippines: ‘authorization validity’ extension

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The Food and Drug Administration (FDA) of the Philippines has issued an amendment to FDA Circular No. 2021-023 extending the current validity of market authorizations, Special Certification, for COVID-19 Test Kits, from 31 December 2021 to 31 January 2022. This extension is valid ONLY for COVID-19 Test Kits whose marketing authorization holder applied for re-issuance

COVID-19 Test Kit in the Philippines: ‘authorization validity’ extension Read More »

Medical device cyber security alert apache log4j

Medical Device cyber security vulnerability: Apache-Log4j

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On 22 December 2021, the Health Sciences Authority (HSA) of Singapore published a medical device advisory alerting all industry stakeholders about a recent suite of cybersecurity vulnerabilities known as the Apache Log4j Vulnerabilities, that could potentially affect medical devices utilizing the Apache Java Logging Library Log4j. These cybersecurity vulnerabilities allow remote code execution by attackers

Medical Device cyber security vulnerability: Apache-Log4j Read More »

Philippines FDA medical device authorizations during public health emergency

Philippines FDA medical device authorizations during state of emergency

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The Philippines FDA issued Circular no. 2021-025 listing the latest guidelines for the application of FDA authorizations in light of the extended state of public health emergency. The extended state of emergency came into effect on 13 September 2021 by Proclamation no. 1218 and will last until 12 September 2022 unless lifted earlier or extended

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Vietnam product labeling new regulation

Vietnam issues new regulation for product labeling

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On 9 December 2021, the Vietnam government released Decree No. 111/2021/ND-CP which amended Decree No. 43/2017/NĐ-CP on product labeling regulation, including medical devices.  This decree will come into effect on 15 February 2022. According to this new decree, organizations and individuals producing, exporting, and importing goods must determine and label the origin of goods, as

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Indonesia Medical Device Online Registrations Temporarily Closed

Indonesia Medical Device Online Registrations to Close Temporarily

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The medical device online registration system in Indonesia, Kemkes, will be shut down temporarily, as of 20 December 2021 to 14 January 2022 for maintenance purposes. This was announced on 1 December 2021 by the Ministry of Health in letter No. UM.01.05/5/2046/2021. This means that the online registration system (http://regalkes.kemkes.go.id) will be closed for the

Indonesia Medical Device Online Registrations to Close Temporarily Read More »

Product classification medical device singapore

Medical Device Product Classification Guidance for Singapore

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New guidance on classifying products as medical devices has been issued by the Health Sciences Authority (HSA), Singapore. The publication of the final document entitled “Medical Devices Product Classification Guide” at the end of November 2021 follows a stakeholder consultation earlier in the year and incorporates additional clarifications on product types as per the feedback

Medical Device Product Classification Guidance for Singapore Read More »

Singapore Regulatory Fee Increase for Medical Devices

Regulatory Fee Increase for Medical Devices in Singapore

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A regulatory fee increase for medical devices in Singapore has been announced by the Health Sciences Authority (HSA). The fee increases apply to various health product categories, retail pharmacies licensing, and permit issuances. The announcement was made on 1 December 2021; the average increment of 3% will take effect on 1 July 2022. The affected

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meet patcharawat andaman medical thailand

Medical device importation to Thailand

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Over the summer, Andaman Medical was happy to welcome a new member of staff in Thailand, Mr. Patcharawat Lertcharoenbundit as Logistics Specialist. The arrival of Patcharawat means we have further strengthened our importation service offering in Thailand. Patcharawat has 4 years’ experience as a Regulatory Affairs Pharmacist; he graduated from the Faculty of Pharmaceutical Sciences

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Vietnam issues new regulation for medical device management

Vietnam issues new regulation for medical device management

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On 8 November 2021, the Vietnam government signed Decree 98/2021/ND-CP regulating the management of Medical Devices. The new decree enters into force on 01 January 2022. From this date, Decree 36/2016/NĐ-CP, Decree 169/2018/NĐ-CP, and Decree 03/2020/NĐ-CP will become obsolete. The new decree covers many aspects of medical device management from registrations to advertising, from import

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Abridged registration in the philippines

Abridged registration process for ASEAN registered medical devices in the Philippines

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Abridged processing for applications of registration or notification of medical devices in the Philippines was introduced on 25 November 2021 as the Food and Drug Administration (FDA) issued Advisory No. 2021-3084. The introduction of this advisory means that medical devices that have already been approved by the regulatory authority of another ASEAN member country will

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Malaysia requirements for supplying Covid-19 self test kits

Requirements For Supplying Covid-19 Rapid Self-Test Kits In Malaysia

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New requirements for supplying COVID-19 Rapid Self-Test Kits in Malaysia were released by the Malaysian Medical Device Authority (MDA) on 10 November 2021 in Guidance Document MDA/GD/0059. The document guides companies on the requirements to follow in order to place Covid-19 Self-Test Kits on the market. This guidance is separate to the guidelines for conditional

Requirements For Supplying Covid-19 Rapid Self-Test Kits In Malaysia Read More »

Vietnam draft Decree on medical device management

Vietnam draft Decree to unify and simplify regulations on the management of medical devices and equipment.

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Over recent years, the Vietnamese Government has issued various Decrees regulating the management of medical devices including: Decree No. 36/2016/ND-CP dated 15 May 2016; Decree No. 169/ND-CP dated 31 December 2018, and Decree No. 03/2020/ND-CP dated 01 January 2020. However, in order to unify regulations on medical device and equipment management, the Ministry of Health

Vietnam draft Decree to unify and simplify regulations on the management of medical devices and equipment. Read More »

Singapore publishes Artificial Intelligence in Healthcare guidelines

Singapore publishes Artificial Intelligence in Healthcare Guidelines (AIHGIe)

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The Ministry of Health (MOH) together with the Health Sciences Authority (HSA) and Integrated Health Information Systems (IHiS) has co-developed a guideline on Artificial Intelligence in Healthcare which was published in October 2021.  The guideline aims to promote good practices and encourage safe development and implementation of artificial intelligence in the healthcare industry. The scope

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Malaysia conditional permission COVD19 self-test kits

Conditional permission for the import & distribution of Covid-19 self-test kits into Malaysia

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To alleviate the burden on frontliners and to ease the detection and control of Covid-19 cases, the Health Ministry’s Medical Devices Authority (MDA) has granted conditional permission for the import and distribution of the Covid-19 self-test kits into the country. Circular letter No. 1/2021 dated 14 July 2021 was posted on the MDA website on

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New post marketing surveillance combined products Malaysia

New Post Marketing Surveillance procedures for Combination Products in Malaysia

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The Malaysian Medical Device Authority (MDA) has released the 4th edition of Guidelines for Registration of Drug-Medical Device and Medical Device-Drug Combination Products on 25 October 2021. The main changes are the inclusion of new Post Marketing Surveillance procedures for Combination Products in Malaysia namely the management of incidents involving registered combination products by the

New Post Marketing Surveillance procedures for Combination Products in Malaysia Read More »

andaman medical exhibiting at medica 2021

Meet Andaman Medical in person at Medica 2021: Hall 10 Stand D54

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We’re really excited to meet you in person at Medica 2021. The Andaman Medical team will be on hand in Hall 10, Stand D54 to discuss your regulatory, importation and post-market compliance needs for Southeast Asia. Our local in-house team of regulatory affairs specialists help manufacturers and distributors worldwide to register medical devices and IVDs

Meet Andaman Medical in person at Medica 2021: Hall 10 Stand D54 Read More »

Vietnam introduces fast track registrations for Covid 19 products

Vietnam introduces fast track importation of certain products related to COVID-19 prevention

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Vietnam’s Ministry of Health introduced new regulations on 16 September 2021 regulating the issuance of fast-track product licenses and the importation of medical equipment for COVID-19 prevention and control. Circular No. 13/2021/TT-BYT immediately came into effect from the date of signing and is effective until 31 December 2022. The Circular includes a list of products

Vietnam introduces fast track importation of certain products related to COVID-19 prevention Read More »

Malaysia Authorized Representative

Malaysia MDA allows multiple authorized representatives for medical devices

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The Malaysian Medical Device Authority (MDA) now allows for multiple authorized representatives for medical devices. This was announced on 14 September 2021, by repealing Circular Letter No. 1/2014 for Establishments Carrying Out the Role as an Authorized Representative (AR) and Establishments Carrying Out Various Activities, which was effective as of 17 June 2021 in accordance

Malaysia MDA allows multiple authorized representatives for medical devices Read More »

Andaman Medical virtual exhibitor at Advamed Medtech Conference 2021

Andaman Medical is a virtual exhibitor at Advamed’s Medtech Conference 2021

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Andaman Medical is proud to be a virtual exhibitor at this Advamed Medtech Conference 2021.  Victoria Caldy and Jon Avent will be on hand to answer attendees’ queries on registering their medical devices and medical equipment in the Southeast Asian countries of Singapore, Malaysia, Indonesia, the Philippines, Thailand, and Vietnam.  As a provider of on-site medical

Andaman Medical is a virtual exhibitor at Advamed’s Medtech Conference 2021 Read More »

Singapore adopts Medical Device Unique Device Identifier

Singapore HSA adopts Unique Device Identifier system

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The Health Sciences Authority (HSA) Singapore has adopted the Medical Device UDI system. This came into effect on 27 August 2021 with the issuing of new UDI Submission Guidelines. The purpose of this system is to improve registered medical devices’ traceability by: Enabling timely identification of devices affected by recalls, failures, serious adverse events, Field

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Vietnam introduces Common Submission Dossier Template

Vietnam to introduce the Common Submission Dossier Template

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The Ministry of Health in Vietnam will officially require the use of the Common Submission Dossier Template (CSDT) for all new class B, C, and D medical device registrations as of 01 January 2022. This requirement was published in Decision No. 2426/QDBYT on 15 May 2021 and came into effect immediately. The Decision contains a

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Singapore HSA consultation Software as a Medical Device

Singapore HSA consultation on Software as a Medical Device Classification

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The Singapore Health Sciences Authority (HSA) has issued draft regulatory guidelines on the Classification of Software as a Medical Device that are open for consultation by stakeholders. Comments may be submitted until 19 August 2021. The draft guidelines cover the classification of non-IVD standalone mobile medical device applications commonly known as Software as a Medical

Singapore HSA consultation on Software as a Medical Device Classification Read More »

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