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 […]
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
Vietnam issues new regulation for medical device management Read More »
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
Abridged registration process for ASEAN registered medical devices in the Philippines Read More »
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 »
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
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
Singapore publishes Artificial Intelligence in Healthcare Guidelines (AIHGIe) Read More »
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
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 »
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’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
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 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 »
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
Singapore HSA adopts Unique Device Identifier system Read More »
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
Vietnam to introduce the Common Submission Dossier Template Read More »
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 »
The Philippines Food and Drug Administration (FDA) has issued a second amendment to its guidelines on FDA-issued authorizations due to the ongoing global pandemic and community quarantine requirements. FDA Circular 2020-024 entitled “Updated guidelines for applications of authorizations with the FDA in light of community quarantine declarations” was first issued on 20 August 2020. It
Philippines FDA issues second update to license application guidelines during Covid-19 Read More »
During the COVID-10 pandemic a list of essential medical devices was drawn up as they were deemed essential for public health in combatting Coronavirus. These products also had a mandatory price ceiling fixed. The Philippines government has since decided to extend this measure to medical devices in general in order to secure supply chains and
The Philippines Food and Drug Administration (FDA) has extended the date for comments on a draft Circular on Banning all Mercury-Containing Thermometers, Sphygmomanometers, Dental Amalgam Capsules and Liquid Mercury for Use in Dental Restorative Purposes. Comments may be submitted until 14 August 2021. This draft circular follows guidelines issued in May 2020 by the Department
Philippines FDA consultation on ban of mercury-containing thermometers Read More »
On 12 July 2021, Indonesia’s Ministry of Finance has just released Regulation No.: 92/PMK.04/2021 which is the third amendment to Regulation No.: 34/PMK.04/2020 concerning the provision of customs facilities and/or excise and taxation on the import of goods for the purposes of handling the Coronavirus pandemic in Indonesia. Regulation No.: 92/PMK.04/2021 lists various products that
Indonesia removes import duty for some Covid-19 related medical devices Read More »
The Ministry of Health in Indonesia is simplifying the registration process for 34 Class A medical devices as well as some Class I and II Household Health supplies (Perbekalan Kesehatan Rumah Tangga or PKRT). The new process will require SDAK (Sertifikat Distribusi Alat Kesehatan) or Medical Device Distribution Certificate (MDDC) holders to obtain Distribution Permit
Indonesia simplifies registration for some Class A medical devices Read More »
The Philippines FDA (Food and Drug Administration) has published a draft version of “Guidelines on the Licensing of Retailers of Medical Devices in the Philippines”. This draft is now open for comments from concerned parties until 24 July 2021. The draft guidelines specify those establishments that are required to obtain licenses to retail medical devices.
Philippines FDA Licensing of Medical Device Retailers Read More »
Andaman Medical is proud to be an Exhibitor Sponsor at this year’s Medtech Integrates Conference 2021 hosted by LifeScience Integrates. Victoria Caldy and Shouzheng Tan 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.
Andaman Medical at Medtech Integrates Conference 2021 Read More »
A Unique Device Identification consultation is underway in Singapore. The Health Sciences Authority (HSA) has issued a draft document entitled “Guidance on the Medical Device Unique Device Identification (UDI) System” so that stakeholders can provide feedback on the document. The consultation is open now until 30 June 2021. Singapore does not currently have a standardized
Unique Device Identification Consultation in Singapore Read More »
Help us in extending another warm welcome to Dang Thi Phuong Thao as part of our growing Andaman Medical team. Thao joins us as Regulatory Affairs Specialist and expert for the Vietnamese market in our office in Hanoi. She will be working alongside our Regulatory Affairs and Market Access team throughout Southeast Asia, assisting clients
Andaman Medical welcomes a third Regulatory Affairs Specialist in Vietnam Read More »
The Philippines FDA has announced a virtual consultation on the draft Reference List of Class A Medical Devices and the draft addendum to the Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”. The PFDA has invited representatives
Philippines FDA Class A Medical Device List Consultation Read More »
Help us in extending a warm welcome to Nguyen Thi Nhat Le-Sunny as part of our growing Andaman Medical team. Sunny joins us as Regulatory Affairs Specialist and expert for the Vietnamese market in our office in Ho Chi Minh City. She will be working alongside our Regulatory Affairs and Market Access team throughout Southeast
Andaman Medical welcomes a new Regulatory Affairs Specialist in Vietnam Read More »
Andaman Medical attends Medtech Canada Regulatory Conference 2021 where we’ll answer attendee’s queries on expanding their presence to the Southeast Asian countries of Singapore, Malaysia, Indonesia, the Philippines, Thailand and Vietnam. As Canada is one of the Global Harmonization Task Force countries, medical devices that are manufactured and registered in Canada enjoy an advantage in
Andaman Medical attends Medtech Canada Regulatory Conference 2021 Read More »
The Malaysian Medical Device Authority has issued an announcement reminding medical device manufacturers, distributors and the public that the Medical Device (Advertising) Regulations 2019 were implemented on 4 May 2021. With full enforcement of the regulations commencing on 1 January 2022. In the meantime, manufacturers, distributors, advertising agencies and other parties concerned may apply for
Medical device advertising regulations in Malaysia Read More »
Thailand’s medical sector is attracting much Foreign Direct Investment; at over 100 times the level of 2020. Thailand has attracted an 80% rise in Foreign Direct Investment applications in the first quarter of 2021 totaling US$3.9 billion, according to the Thailand Board of Investment. The medical sector drew a large share of the investments with
Thailand’s medical sector attracts x100 times more investment in Q1 2021 than in 2020 Read More »
The Code of Advertisement is a Guidance Document (MDA/GD/0032) issued by the Malaysian Medical Device Authority (MDA) to ensure good marketing practices and advertising messages that are socially responsible and ethical. It forms part of the Medical Device (Advertising) Regulations 2019 in Malaysia that were fully implemented on 4 May 2021. Please note that the
Malaysia: Code of Advertisement Medical Device Regulations Read More »
