REGULATORY NEWS & UPDATES

The ARQon Gazette News

      Global Regulatory & Quality Bulletin 
The ARQon Gazette is a compilation of latest updates in the medical device and drug industry. These updates might have an impact to manufacturers and other industry participants.
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December 4, 2019

  • Australia: Proposed changes to the Essential Principles for safety and performance

  • Australia: Proposed changes to the requirements for systems and procedure packs

  • Australia: Feedback sought on the regulation of certain self-testing IVDs in Australia

  • ...

August 29, 2019

CDRRHR shared the following statistics:

Manufacturers/Repacker: 74

Trader: 51

Distributors – Wholesalers, Importers, Exporters: 2,470

(Note: 95% of medical devices are imported)

The regulatory information updates, including:

The instrument to implement the AMDD is the Admini...

March 28, 2019

The Association of Southeast Asian Nations (ASEAN) have published the following two documents under the section of Harmonisation of Standards & Technical Requirements by ASEAN Medical Device Committee (AMDC):​

December 14, 2018

The AO 2018-002 provides guidelines governing the issuance of an authorization for a medical device based on the ASEAN Harmonized Technical Requirements, based on the Common Submission Dossier Template (CSDT). Medical devices will be classified into four categories - C...

December 11, 2018

The AMDTC is working on the following two key work items:

  • Classification of products as Medical Device or Non-Medical Device in the different ASEAN Member States (AMS);

  • Risk classification of identified medical devices with a view to align among the AMS.

The...

August 30, 2018

Philippines: On 6 June 2018, the Philippines FDA released Memorandum No. 2018-011, revealing the regulation criteria of the three consumer products. FDA has mentioned that, unless with sufficient data, consumer products without health and therapeutic capabilities will ...

August 30, 2018

ASEAN: The Meeting was attended by delegates from Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, Viet Nam and representatives from the ASEAN Secretariat. The Representatives from ASEAN Pharmaceutical Industry Club...

August 30, 2018

ASEAN: This month's ASIAN MEDTECH ASSOCIATION's REGULATORY networking discussions cover the current progress of the Thai medical device regulation, which must be in place before the national elections; Vietnam's efforts to introduce practical, workable device regulatio...

August 30, 2018

Singapore

The Health Sciences Authority (HSA) regulates health products to ensure that they meet the required standards of quality, safety and efficacy.  There are fees in place to help cover the cost of registration, licensing, notification and permit issuance for ther...

April 11, 2018

Questions for ASEAN 

General

  1. Can we have the slides from the regulators update?

  2. What changes can to AMDD can be expected with EU MDR and EU IVD update and when?

  3. What are the change notification procedures for the different countries (particularly for Vietna...

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