Special Access Routes for Covid-19 Related Products - ASEAN Countries
Singapore Industry is preparing for Product, Importer/Wholesaler Licence with GDPMDS compliance where HSA is looking at transition period...
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ARQon
Feb 6, 20202 min read
Asia, Africa, Middle East - Jan/Feb 2020
Australia: Fees and charges proposed for 2020–2021 Australia: Regulatory changes for software, personalised medical devices and IVD...
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ARQon
Jan 8, 20204 min read
Vietnam Officialised Amendments 03/2020/ND-CP to Decree No.36/2016/ND-CP & Decree No.169/2018/ND-CP
Pursuant to the Law on the Government Organization dated 19/06/2015; in consideration of the proposal of the Minister of Health, the...
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ARQon
Jan 3, 20201 min read
Thailand Breast Implant Regulation: B.E. 2562
Breast Implant regulation: B.E. 2562 Main content revision from regulation B.E. 2540 Signed date: 7 November 2019 Announced date: 18...
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ARQon
Dec 26, 20191 min read
ASEAN Cosmetic Directive (ACD) Annexes amendment
The ASEAN Cosmetic Directive (ACD) is an agreement among ASEAN countries to harmonize the requirements of cosmetic products so as to...
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ARQon
Aug 28, 20191 min read
ASEAN Medical Device Committee Meeting Updates in Philippines
The 8th ASEAN Medical Device Committee was held from the 7-8 August 2019 in Philippines. The table below shows the update on ASEAN...
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ARQon
Mar 28, 20191 min read
7th AMDC: ASEAN Borderline and Harmonized Classification documents released
The Association of Southeast Asian Nations (ASEAN) have published the following two documents under the section of Harmonisation of...
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ARQon
Mar 28, 20191 min read
ASEAN Updates for Malaysia, Vietnam: Asian Medtech Associations Regulatory Networking
Executive Summary: The latest Asian Medtech Associations Regulatory Networking discussions extended to news from Malaysia, Vietnam,...
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ARQon
Dec 17, 20181 min read
Cambodia recognises Drug-Device Combination Status in Singapore, Malaysia and Indonesia
As of present, there are a total of 1,985 medical devices and 1,136 reagents registered. Currently in Cambodia, the AMDD is already...
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ARQon
Dec 17, 20181 min read
Malaysia Unregistered Route for Export-Only & Diagnostics-Only Devices
MDA shed the light on the following statistics: Total establishment license: 2,300 Establishments; Manufacturers: 230 Authorized...
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ARQon
Dec 17, 20182 min read
Myanmar FDA Releases List of 126 Exempted Devices & Steps up on Post Market Surveillance
Myanmar releases updates on the various changes to their regulatory process in the most recent 7th AMDC Meeting. The Myanmar Department...
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ARQon
Dec 17, 20182 min read
Thailand FDA shares 2019 Medical Device Regulation Plan
During the 7th AMDC Meeting, the medical device control division released updates on the pre-market and post-market control of medical...
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ARQon
Dec 17, 20182 min read
Good News: Singapore Immediate Placement for Class B & C with 1 Reference Regulatory Approval
In recent ASEAN meeting, Singapore HSA has reiterated the country's initiative to enhance the facilitation of immediate market access....
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ARQon
Dec 14, 20181 min read
The Philippines registration phases of AMDD begins on 30 March 2019
The AO 2018-002 provides guidelines governing the issuance of an authorization for a medical device based on the ASEAN Harmonized...
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ARQon
Dec 14, 20181 min read
Laos FDD issues Import License Certificate based on Importation Request Submission
Current situation in Laos: 36 Companies involved in medical device market 1 medical device factory 98% of medical devices are imported...
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ARQon
Dec 14, 20181 min read
Indonesia Reduces Registration Timeline & Promotes Business Set-Up for Overseas Companies
Indonesia is attempting to simplify regulations by reducing the time needed for review, promoting easier access for license application...
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ARQon
Dec 11, 20181 min read
Key Endorsements in the 7th AMDC Meeting
The AMDTC is working on the following two key work items: Classification of products as Medical Device or Non-Medical Device in the...
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ARQon
Dec 10, 20182 min read
Singapore HSA drafts user-friendly ASEAN CSDT Guidance and e-Submission Guide, complements ARQon tal
Singapore HSA has recently announced possible changes to the guidance documents GN-17 and GN-18. These changes are currently opened for...
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ARQon
Aug 30, 20181 min read
ASEAN - 25th meeting of the Pharmaceutical Product Working Group (PPWG)
ASEAN: The Meeting was attended by delegates from Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines,...
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ARQon
Apr 11, 20187 min read
The 6th ASEAN Medical Device Committee (AMDC) Meeting 3-6 April 2018
Questions for ASEAN General Can we have the slides from the regulators update? What changes can to AMDD can be expected with EU MDR and...
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