Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018
Part 4Class III medical devices
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Column 3Conformity assessment document relating to manufacturer’s quality management system
Column 4Conformity assessment document relating to product assessment
1
Therapeutic Goods Administration
a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 1 of Schedule 3 to the Regulations (full quality assurance procedures), excluding clause 1.6 of that Part
a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in clause 1.6 of Part 1 of Schedule 3 to the Regulations (examination of design)
2
Therapeutic Goods Administration
a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations:for a medical device that the manufacturer intends to be supplied in a sterile state:Part 4 (production quality assurance procedures);for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:Part 3 (verification procedures); orPart 4 (production quality assurance procedures)
a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 2 of Schedule 3 to the Regulations (type examination procedures)
3
a notified body within the meaning of Council Directive 93/42/EEC
a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Annex
an EC design-examination certificate issued under section 4 of Annex II of Council Directive 93/42/EEC
4
a notified body within the meaning of Council Directive 93/42/EEC
for a medical device that the manufacturer intends to be supplied in a sterile state:a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC; ora production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC
an EC type-examination certificate issued under Annex III of Council Directive 93/42/EEC
5
a notified body within the meaning of Council Directive 90/385/EEC
a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC
an EC design examination certificate issued under section 4 of Annex 2 of Council Directive 90/385/EEC
6
a notified body within the meaning of Council Directive 90/385/EEC
for a medical device that the manufacturer intends to be supplied in a sterile state:an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC;for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:an EC verification certificate issued under Annex 4 of Council Directive 90/385/EEC; oran assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC
an EC type-examination certificate issued under Annex 3 of Council Directive 90/385/EEC
7
a notified body within the meaning of the EU medical devices regulation
an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation
an EU technical documentation assessment certificate issued under Chapter II of Annex IX of the EU medical devices regulation
8
a notified body within the meaning of the EU medical devices regulation
(a) for a medical device that the manufacturer intends to be supplied in a sterile state:(i) a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation;(b) for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:(i) a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation; or(ii) an EU product verification certificate issued under Part B of Annex XI of the EU medical devices regulation
an EU type-examination certificate issued under Annex X of the EU medical devices regulation
9
Japan’s Ministryof Health, Labour and Welfare orthe Japanese Pharmaceuticalsand Medical Devices Agency
either of the following:a MDSAP certificate; ora quality management system certificate for the purposes of the Japanese PMD Act
a pre-market approval issued under the Japanese PMD Act
10
Health Canada
a MDSAP certificate
a Class IV medical device licence issued under the Canadian medical devices regulations
11
United StatesFood and Drug Administration
a MDSAP certificate
one of the following:(a) a determination of substantial equivalence made with respect to a notification submitted under section 510(k) of the US FDC Act;(b) an order approving an application for premarket approval under section 515 of the US FDC Act
12
United StatesFood and Drug Administration
an order approving an application for premarket approval under section 515 of the US FDC Act
13
Health Sciences Authority of Singapore
an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class D medical device
14
a UK approved body
a full quality assurance system certificate or other document issued under Annex II in applied Directive 93/42, excluding section 4 of that Annex
a design examination certificate issued under section 4 of Annex II in applied Directive 93/42
15
a UK approved body
(a) for a medical device that the manufacturer intends to be supplied in a sterile state—a production quality assurance certificate or other document issued under Annex V in applied Directive 93/42;(b) for a medical device that the manufacturer intends to be supplied in a non-sterile state—either of the following:(i) a verification certificate of conformity issued under Annex IV in applied Directive 93/42;(ii) a production quality assurance certificate or other document issued under Annex V in applied Directive 93/42
a type‑examination certificate issued under Annex III in applied Directive 93/42
16
a UK approved body
a complete quality assurance system certificate or other document issued under section 3 of Annex 2 in applied Directive 90/385
a design examination certificate issued under section 4 of Annex 2 in applied Directive 90/385
17
a UK approved body
for a medical device that the manufacturer intends to be supplied in a sterile state—an assurance of production quality certificate or other document issued under Annex 5 in applied Directive 90/385;(b) for a medical device that the manufacturer intends to be supplied in a non-sterile state—either of the following:(i) a verification certificate of conformity issued under Annex 4 in applied Directive 90/385;(ii) an assurance of production quality certificate or other document issued under Annex 5 in applied Directive 90/385
a type‑examination certificate issued under Annex 3 in applied Directive 90/385
Schedule 2—IVD medical devices
Note: See section 6.
Part Part 4 - Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018 - Class III medical devices | Zoe