Vietnam

Dec 21 min read

Vietnam: Addressing Import License Expirations in Vietnam (by 25 December 2024)

On behalf of the Ministry of Health of Vietnam, the Infrastructure and Medical Device Administration (IMDA) has requested all related...

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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...

1,044 views0 comments

ARQon

Dec 23, 20192 min read

Vietnam Further Amendments for Class B on Jan 2021 & Class C and D on Jan 2022

The Vietnamese MOH has released the proposed amendment at the end of 2019 to the Vietnamese medical device industry while waiting for the...

318 views0 comments

ARQon

Jun 28, 20192 min read

Asia, Africa & Middle East - Jun 2019

Australia: Proposed reclassification of spinal implantable medical devices Australia: Proposed regulatory scheme for personalised medical...

88 views0 comments

ARQon

Jun 28, 20191 min read

Asia Reg News: AHWP Catch-up, Korea, Malaysia, Indonesia and Vietnam Updates

Executive Summary: Part 1 of this month's Asian Medtech Associations Regulatory Networking discussions features Asean medtech market...

97 views0 comments

ARQon

Mar 29, 20191 min read

Asia, Africa & Middle East - Mar 2019

Australia: Reclassification of surgical mesh devices and publication of associated guidance Australia: Proposed fees and charges for...

92 views0 comments

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...

299 views0 comments

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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Key Endorsements in the 7th AMDC Meeting

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...

111 views0 comments

ARQon

Sep 4, 20182 min read

Asia, Africa & Middle East - Aug/Sep 2018

Australia: 2018 fees and charges released by the Therapeutic Goods Administration Australia: Application fee now charged for a Class I...

74 views0 comments

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,...

596 views0 comments

ARQon

Aug 30, 20181 min read

MEDTECH ASSOCIATIONS REGULATORY NETWORKING - Malaysia, Philippines, Thailand & Vietnam

ASEAN: This month's ASIAN MEDTECH ASSOCIATION's REGULATORY networking discussions cover the current progress of the Thai medical device...

72 views0 comments

ARQon

May 23, 20182 min read

Asia, Africa & Middle East - May 2018

Australia: Changes to the therapeutic goods advertising framework Australia: Guidance on updating an existing Class 1–3 in-house IVD...

74 views0 comments

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...

664 views0 comments

ARQon

Feb 2, 20182 min read

Asia, Africa & Middle East - February 2018

Australia: ‘Therapeutic Goods (Manufacturing Principles) Determination 2018’ Australia: Implementation of new Uniform Recall Procedure...

55 views0 comments

ARQon

Jan 1, 20181 min read

Asia, Africa & Middle East - December 2017

Australia: Articles that alter the pH of body fluids are not medical devices Australia: Up-classification of surgical mesh and provision...

462 views0 comments

ARQon

Dec 29, 20171 min read

Vietnam Decree extended until 31 December 2018

DMEC had a meeting with Vietnam MOH where the 1 year extension of new decree implementation has been approved. The medical device in the...

36 views0 comments

ARQon

Aug 24, 20172 min read

Asia, Africa & Middle East - May 2017

Australia: Therapeutic Goods Amendment (2016 Measures No 1) Bill 2016 Australia: Consultation held on future regulation of low risk...

91 views0 comments

ARQon

Jul 11, 20171 min read

Vietnam On Track Launching New System, Plus Updates From Bangladesh, Hong Kong

Executive Summary: All eyes are on Vietnam, which is on the threshold of a new regulatory system for medical devices. But the smaller...

44 views0 comments

Vietnam Decree, Malaysia Labels and More

ARQon

Oct 17, 20161 min read

Vietnam Decree, Malaysia Labels and More

Vietnam's Decree on Management of Medical Devices (No. 36/2016/ND-CP) is coming soon - probably sooner than expected for the unprepared....

241 views0 comments

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