Certificate Number
AU Q00154

Conformity Assessment Certificate
Production Quality Assurance Procedures
Schedule 3, Part 4 of the Therapeutic Goods (Medical Devices) Regulations 2002

Issued toManufacturer Name:
Manufacturer Address:

The Pipette Company Pty Ltd

Unit 13/ 22 Ware Street
THEBARTON SA 5031
Australia

For the Manufacture and Final inspection of the device categories listed on page 2 of this certificate.
This is to certify that the quality management system described below complies with the relevant
provisions of Schedule 3, Part 4 of the Therapeutic Goods (Medical Devices) Regulations 2002.
Certification is based on an assessment of the Production Quality Management System for theproduction and final inspection to ensure that each medical device to which the system is applied
conforms to the type described in the scope of the respective Type Examination certificate (Schedule3, Part 2) or is in accordance with the technical documentation prepared by the manufacturer under
Schedule 3, clause 6.4.
This certificate has effect at all times from the commencement date, until the end of the period
specified in the certificate (expiry date), or unless it has been suspended or revoked.
Commencement Date:

Certificate Expiry Date:25 May 201825 May 2023

This certificate is issued under Section 41EE of the Therapeutic Goods Act 1989 by:
Jie ZhouSigned electronicallyDelegate of the Secretary
Medical Devices Branch
Therapeutic Goods Administration
PO Box 100, Woden ACT 2606 Australia

TGA Conformity Assessment Certificate

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Certificate Number
AU Q00154

Scope of Certificate
Manufacturer Facilities
Name and Address

Scope

1

The Pipette Company

Labeling, Distribution, Warehousing

2

The Pipette Company
Unit 13, 22 Ware Street
Thebarton SA 5031
Australia

Production, Packaging, Labeling, Quality
control, Distribution, Warehousing, Releasefor supply

Unit 15, 22 Ware Street
Thebarton SA 5031
Australia

Manufacture and Final Inspection of Device Categories
Description
1

Limitations (if applicable)

Micropipettes Supplied sterile

Critical Suppliers
1

Name and Address

Scope

Steritech Pty Ltd
160 South Gippsland Highway
Dandenong VIC 3175
Australia

Gamma sterilisationTGA Conformity Assessment Certificate

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Certificate Number
AU Q00154

Certificate History
Version Details
1.1
2.1
2.2
3.1

Issue Date

File Reference

28 May 20082007/010391

Update the scope of manufacturer facilities

25 August 2017

E17-23827

Recertification

25 May 2018

E18-209790Initial certification

Recertification & reformatting of certificate
Addition of new temporary storage facility

Update the certificate version numbers - internalmodification.

Certificate Location (Manufacturer Root File Number):

TGA Conformity Assessment Certificate

27 May 20132013/003046

2010/010764

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Certificate Number
AU Q00154

Conditions
The following conditions apply automatically under Section 41EJ of the Therapeutic Goods Act 1989:

Entry and inspection powers(1) A conformity assessment certificate is subject to the conditions that the manufacturer in respect ofwhom the certificate is issued will:(a) allow an authorised person:(i) to enter, at any reasonable time, premises (including premises outside Australia) at which theperson or any other person deals with medical devices of a kind covered by the certificate;and(ii) while on those premises, to inspect those premises and medical devices of any kind on thosepremises and to examine, take measurements of, conduct tests on, require tests to beconducted on or take samples of medical devices of any kind on those premises or any thing
on those premises that relates to medical devices of any kind; and(iii) while on those premises, to make any still or moving image or any recording of thosepremises or any thing on those premises; and(b) if requested to do so by an authorised person:(i) produce to the person such documents relating to devices of a kind covered by the certificate,or to the manufacturer’s quality management system, as the person requires; and(ii) allow the person to copy the documents.

Review(2) A conformity assessment certificate is subject to the condition that the manufacturer in respect ofwhom the certificate is issued will cooperate in any review by the Secretary of the certificate todetermine whether the conformity assessment procedures relating to the following matters have been
applied to the kinds of medical devices covered by the certificate:(a) the application of quality management systems for the manufacture of medical devices;(b) the certification of compliance with the essential principles;(c) any other requirement of the conformity assessment procedures specified in the regulations madefor the purposes of subsection 41EC(2).
Notification of substantial changes(3) A conformity assessment certificate is subject to the condition that the person in respect of whom thecertificate is issued will notify the Secretary, in writing, of any plan for substantial changes to:(a) quality management systems; or(b) the product range covered by those systems; or(c) the product design of kinds of medical devices;in respect of which the certificate is issued.

Fees(4) A conformity assessment certificate is subject to the condition that the applicant for the certificate will
pay a fee, prescribed in the regulations, for a review under subsection (2), when the fee becomes dueand payable.
(5) The regulations may prescribe different levels of fees for different kinds of manufacturers and medicaldevices.
Conditions in regulations(5A) A conformity assessment certificate is subject to any conditions prescribed by the regulations for thepurposes of this subsection.
Conditions do not limit other conditions(6) A condition imposed under this section is in addition to any conditions imposed under this Division.

TGA Conformity Assessment Certificate

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