Electronic

Main information

  • Trade name:
  • Electronic insulin pen
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Electronic insulin pen
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217351
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217351

Digital Medics Pty Ltd - Electronic insulin pen

ARTG entry for

Medical Device Included Class IIb

Sponsor

Digital Medics Pty Ltd

Postal Address

Suite 70 377 Kent Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

15/11/2013

Product category

Medical Device Class IIb

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Diamesco Co Ltd

Migun Techno World II 305 533-1

Yongsan-dong

Yuseong-gu, Daejeon, 305-500

Korea - Republic of

Products

1. Electronic insulin pen

Product Type

Single Device Product

Effective date

15/11/2013

GMDN

45819 Electronic insulin pen

Intended purpose

A portable, hand-held, battery-powered device, typically in the form of a large pen, designed to be used by

a diabetic patient to subcutaneously inject a dose of insulin through a replaceable needle. A replaceable

cartridge filled with insulin is inserted into the device and typically a dial on the device is operated for

dosing; only the cartridge is discarded when the insulin is exhausted. In addition, the device is capable of

electronic memory functions such as the recording and display of the date, time, and amount of previous

doses. This is a reusable device

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 02:34:38 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

11-9-2018

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On September 19, 2018, the FDA will host the third of a three-part eSubmitter webinar series. This session will provide a platform to answer any remaining questions participants may have after attending or viewing the first two webinars on the use of CVM’s electronic submission tool, eSubmitter.

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Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

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Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

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Maquet Datascope Corp. is recalling the IABP due to a design issue that allows fluid (such as saline) to seep into the device. The fluid can cause corrosion of internal components such as the electronic circuit boards, and lead to device malfunction (e.g., sudden stops) which can cause a delay or interruption in therapy. Device failure may result in immediate and serious adverse health consequences, including death.

FDA - U.S. Food and Drug Administration

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Regulatory Submissions in Electronic Format for Biologic Products

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3-5-2018

CVM eSubmitter Webinar 1 Agenda

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FDA - U.S. Food and Drug Administration

1-3-2018

All marketing authorisation letters are now sent electronically to Danish companies

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Danish Medicines Agency

20-9-2017

Decisions on marketing authorisations will be sent electronically to Danish recipients from October 2017

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Danish Medicines Agency

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Danish Medicines Agency

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Guide to individual case safety reporting

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FDA - U.S. Food and Drug Administration

15-8-2018

Electronic Instructions for Use - eIFU

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Therapeutic Goods Administration - Australia

22-7-2018

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FDA - U.S. Food and Drug Administration

26-6-2018

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Therapeutic Goods Administration - Australia

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Electronic submissions

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13-6-2018

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