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ARQon
Dec 30, 20242 min read
Indonesia: Dried Blood Spot (DBS) Products Now Classified as Medical Devices (w.e.f. 9 December 2024)
Recently, the Ministry of Health of Indonesia announced that Kertas Saring, also known as Dried Blood Spot (DBS) , will be recognized as...
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ARQon
Dec 23, 20242 min read
Indonesia: Online Certification and Medical Device Licensing Systems to Close Temporarily
The Ministry of Health of Indonesia has temporarily closed the Medical Device Licensing and Online Certification Systems for scheduled...
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ARQon
Nov 12, 20241 min read
Indonesia: New Requirements for Medical Device Distributors Licensing Compliance (w.e.f 1 January 2025)
The Ministry of Health of Indonesia has introduced new guidelines for medical device distributors to enhance regulatory compliance,...
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ARQon
Sep 23, 20241 min read
Indonesia: Mandatory GDP Certification for Medical Devices in the e-Katalog (w.e.f 1 January 2025)
The Ministry of Health of the Republic of Indonesia released a circular no. HK.02.02/E/1753/2024 to address the implementation of the...
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ARQon
May 29, 20241 min read
Indonesia: Implementation of GDPMD Certification (CDAKB) as Marketing Authorization Requirement
The Indonesia Ministry of Health published an announcement on 11 May 2024, under Announcement No: FR.03.01/E/884/2024 about the...
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ARQon
Dec 24, 20192 min read
Indonesia: Update on ANTRIAN Consultation Guidelines, Product Change Criteria and Fee
MOH Indonesia published the Guideline for Consultation with MOH Directorate Medical device and House-hold product on 24 December 2019,...
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ARQon
Dec 4, 20192 min read
Asia, Africa & Middle East - Nov/Dec 2019
Australia: Proposed changes to the Essential Principles for safety and performance Australia: Proposed changes to the requirements for...
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ARQon
Aug 28, 20191 min read
Indonesia: Medical Devices Economy & Regulatory Update
Indonesia Encourages Investment Economic growth shows an increasing trend, and this includes the Pharma and Medical Device Industry New...
143 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...
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ARQon
May 30, 20193 min read
Halal Registration in Indonesia for Medical Devices, Drugs, Cosmetic, Food
PP JPH has been signed by the President on 29 April 2019 and promulgated on 3 May 2019. However, the PP copy has not yet been published,...
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ARQon
Mar 29, 20191 min read
Indonesia MOH Go Digital to help Industry with Online Medical Device Classification / HS code, Digit
Online Medical Device Classification Guideline MOH Indonesia provides online classification guideline to help applicant to define the...
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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...
299 views0 comments
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
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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