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Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018
Division 2Class I medical devices that are intended to be supplied in a sterile state or have a measuring function
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Division 2—Class I medical devices that are intended to be supplied in a sterile state or have a measuring function
| Column 1Item | Column 2Regulatory authority | 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 one of the following Parts of Schedule 3 to the Regulations:(a) for a medical device that the manufacturer intends to be supplied in a sterile state (whether or not it has a measuring function):(i) Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; or(ii) Part 4 (production quality assurance procedures);(b) for a medical device that has a measuring function (and that the manufacturer intends to be supplied in a non-sterile state):(i) Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part;(ii) Part 3 (verification procedures);(iii) Part 4 (production quality assurance procedures); or(iv) Part 5 (product quality assurance procedures) | |
| 2 | a notified body within the meaning of Council Directive 93/42/EEC | (a) for a medical device that the manufacturer intends to be supplied in a sterile state (whether or not it has a measuring function), either of the following:(i) a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part; or(ii) a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC;(b) for a medical device that has a measuring function (and that the manufacturer intends to be supplied in a non-sterile state), one of the following:(i) a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part;(ii) an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC;(iii) a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; or(iv) a product quality assurance certificate or other document issued under Annex VI of Council Directive 93/42/EEC | |
| 3 | a notified body within the meaning of Council Directive 90/385/EEC | (a) for a medical device that the manufacturer intends to be supplied in a sterile state (whether or not it has a measuring function), either of the following:(i) a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC; or(ii) an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC;(b) for a medical device that has a measuring function (and that the manufacturer intends to be supplied in a non-sterile state), one of the following:(i) a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC;(ii) an EC verification certificate issued under Annex 4 of Council Directive 90/385/EEC; or(iii) an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC |