Case Studies

Dried Blood Spot Collection Kit

device classification

Class IIa

GMDN Term

GMDN 38092 - Capillary blood collection set, home-use

Objective

Use the existing device/s conformity assessment to gain Australian Market Entry as a System or Procedure Pack (SoPP).

Outcomes

The team at AMDS reviewed the information at hand and produced a list of appropriate conformity assessment pathways (in hand with the manufacturer) for each of the devices within the procedure pack. Evidence for each device was maintained and submitted to the TGA along with product packaging information. Following resolution of a non-mandatory application audit, the ARTG certificate was granted.

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Jaw physiology evaluation system

device classification

Class I

GMDN Term

GMDN 475225 Jaw physiology evaluation system - Medical device accessory designed to record mandibular kinematics.

Objective

Transfer of sponsorship from an existing sponsor to Australian Medical Device Sponsors.

Outcomes

Australian Medical Device Sponsors arranged the transfer documentation and correspondence with the existing sponsor in order to transition the device under our name. The transfer paperwork was submitted to the TGA for review and approval. Australian Medical Device Sponsors created and submitted manufactures evidence to support the ARTG entry. The evidence was accepted by the TGA within 3 days of submission. A new ARTG certificate were issued to the manufacturer within 30 days.

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Jaw physiology evaluation system

device classification

Class IIa

GMDN Term

GMDN 47556 - Jaw physiology evaluation system. A software medical device intended to record and analyze mandibular kinematic to help diagnosis, characterization and therapeutic planning of occlusion patterns

Objective

Tranfer of sponsorhip from an existing sponsor to Australian Medical Device Sponsors.

Outcomes

Australian Medical Device Sponsors arranged the transfer documentation and correspondence with the existing sponsor in order to transition the device under our name. The transfer paperwork was submitted to the TGA for review and approval. Australian Medical Device Sponsors created and submitted manufactures evidence to support the ARTG entry. The evidence was accepted by the TGA within 3 days of submission. A new ARTG certificate were issued to the manufacturer within 30 days.

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