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, 2019
- 2 min
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, 2019
- 2 min
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, 2019
- 1 min
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...
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ARQon
- Jun 28, 2019
- 1 min
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, 2019
- 3 min
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, 2019
- 1 min
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, 2019
- 1 min
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
- Dec 14, 2018
- 1 min
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, 2018
- 1 min
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, 2018
- 1 min
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, 2018
- 7 min
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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