Common use of DESIGNATED CONFORMITY ASSESSMENT BODIES Clause in Contracts

DESIGNATED CONFORMITY ASSESSMENT BODIES. The conformity assessment bodies designated by New Zealand to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New Zealand’s legislative, regulatory and administrative requirements The designated conformity assessment bodies are: [Names and details to be inserted][Note: Further names and details to be added as required] The designated conformity assessment bodies are: [Names and details to be inserted] [Note: Further names and details to be added as required] SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by New Zealand For the conformity assessment bodies designated by the European Community Under the authority of the New Zealand Government:(a) For Certification Bodies: — The Joint Accreditation System of Australia and New Zealand (XXX-ANZ) (b) For Testing Laboratories and Inspection Bodies: — The Testing Laboratory Registration Council of New Zealand — Belgium Ministère de l’Economie Ministerie van Economie — Denmark Direktoratet for Arbejdstilsynet — Germany Bundesministerium für Arbeit und Sozialordnung — Greece Υnoυργsío Ανánuυ3ης Ministry of Development — Spain Ministerio de Industria y Energía — France Ministère de l’économie, des finances et de l’industrie Secrétariat d’Etat à l’industrie Direction de l’action régionale et de la petite et moyenne industrie Sous direction de la sécurité industrielle Ministère de l’économie, des finances et de l’industrie Secrétariat d’Etat à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Enterprise and Employment — Italy Ministero dell’Industria, del Commercio e dell’Artigianato — Luxembourg Ministère des transports — Netherlands Staat der Nederlanden — Austria Bundesministerium für Wirtschaftliche Angelegenheiten — Portugal Under the authority of the Government of Portugal: Instituto Português da Qualidade — Finland Kauppa- ja teollisuusministeriö/Handels- och industriministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — UK Department of Trade and Industry

DESIGNATED CONFORMITY ASSESSMENT BODIES. The conformity assessment bodies designated by New Zealand to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New Zealand’s legislative, regulatory and administrative requirements The designated conformity assessment bodies are: [Names Name and details to be inserted][Note: Further inserted][Further names and details to be added as required] The designated conformity assessment bodies are: [Names Name and details to be inserted] [Note: Further names and details to be added as required] SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies designated by New Zealand For the conformity assessment bodies designated by the European Community Under the authority of the New Zealand Government:(aGovernment: (a) For Certification Bodies: — The the Joint Accreditation System of Australia and New Zealand (XXX-ANZ) (b) For Testing Laboratories and Inspection Bodies: — The Testing Laboratory Registration Council of New Zealand — Belgium Ministère de l’Economie Ministerie van Economie — Denmark Direktoratet for Arbejdstilsynet — Germany Bundesministerium für Arbeit und Sozialordnung — Greece Υnoυργsío Ανánuυ3ης Ministry of Development — Spain Ministerio de Industria y Energía — France Ministère de l’économie, des finances et de l’industrie Secrétariat d’Etat à l’industrie Direction de l’action régionale l’emploi et de la petite et moyenne industrie Sous direction de la sécurité industrielle solidarité Direction des relations du travail Xxxxxx XX0 Ministère de l’économie, des finances et de l’industrie Secrétariat d’Etat à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Enterprise and Employment — Italy Ministero dell’Industria, del Commercio e dell’Artigianato — Luxembourg Ministère des transports — Netherlands Staat der Nederlanden For the conformity assessment bodies designated by New Zealand For the conformity assessment bodies designated by the European Community — Austria Bundesministerium für Wirtschaftliche wirtschaftliche Angelegenheiten — Portugal Under the authority of the Government of Portugal: Instituto Português da Qualidade — Finland Kauppa- Sosiaali- ja teollisuusministeriö/Handels- terveysministeriö/ Social- och industriministeriet hälsovårdsministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — UK Department of Trade and Industry

DESIGNATED CONFORMITY ASSESSMENT BODIES. The conformity assessment bodies designated by New Zealand to assess products against the European Community’s legislative, regulatory and administrative requirements The conformity assessment bodies designated by the European Community to assess products against New Zealand’s legislative, regulatory and administrative requirements The designated conformity assessment bodies are: [Names Name and details to be inserted][Note: Further names and details to be added as required] The designated conformity assessment bodies are: [Names Name and details to be inserted] [Note: Further names and details to be added as required] SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies Conformity Assessment Bodies designated by New Zealand For the conformity assessment bodies Conformity Assessment Bodies designated by the European Community Under the authority of the New Zealand Government:(a) For Certification Bodiescertification bodies: — The Joint Accreditation System of Australia and New Zealand (XXX-ANZ) ), and (b) For Testing Laboratories and Inspection Bodies: — The Testing Laboratory Registration Council of New Zealand Zealand. — Belgium Ministère de l’Economie des affaires economiques Ministerie van Economie Economische Zaken — Denmark Direktoratet for Arbejdstilsynet Boligministeriet — Germany Bundesministerium für Arbeit und Sozialordnung — Greece Υnoυργsío Ανánuυ3ης Ministry of Development — Spain Ministerio de Industria y Energía — France Ministère de l’économie, des finances et de l’industrie Secrétariat d’Etat à l’industrie Direction de l’action régionale et de la petite et moyenne industrie Sous direction de la sécurité industrielle Ministère de l’économie, des finances et de l’industrie Secrétariat d’Etat d’État à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Enterprise and Employment — Italy Ministero dell’Industria, del Commercio e dell’Artigianato — Luxembourg Ministère des transports — Netherlands Staat der Nederlanden — Austria Bundesministerium für Wirtschaftliche Angelegenheiten — Portugal Under the authority of the Government of Portugal: Instituto Português da Qualidade — Finland Kauppa- ja teollisuusministeriö/teollisuusministeriö/ Handels- och industriministeriet — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — UK Department of Trade and Industry

DESIGNATED CONFORMITY ASSESSMENT BODIES. The conformity assessment bodies Conformity Assessment Bodies designated by New Zealand Australia to assess products against the European Community’s legislative, legislative and regulatory and administrative requirements The conformity assessment bodies Conformity Assessment Bodies designated by the European Community to assess products against New ZealandAustralia’s legislative, legislative and regulatory and administrative requirements The designated conformity assessment bodies are: [Names Name and details to be inserted][Noteinserted] [Note : Further names and details to be added as required] The designated conformity assessment bodies are: [Names Name and details to be inserted] [NoteNote : Further names and details to be added as required] SECTION III THE : AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies Conformity Assessment Bodies designated by New Zealand Australia For the conformity assessment bodies Conformity Assessment Bodies designated by the European Community Under the authority of the New Zealand Government:(aGovernment of Australia: a) For Certification Bodies: — The • the Joint Accreditation System of Australia and New Zealand (XXX-XXX- ANZ) (b) For Testing Laboratories and Inspection Bodies: — The • the National Association of Testing Laboratory Registration Council of New Zealand — Authorities, Australia (NATA) · Belgium Ministère de l’Economie l'Emploi et du Travail Ministerie van Economie — Tewerkstelling en Arbeid • Denmark Direktoratet for Arbejdstilsynet — • Germany Bundesministerium für Arbeit und Sozialordnung — • Greece Υnoυργsío Ανánuυ3ης ⌫ÐŒA6Ufl€Œ §ESЧAŁ€6 Ministry of Development — • Spain Ministerio de Industria Industria, Comercio y Energía — Turismo • France Ministère du Travail et des Affaires Sociales et Ministère de l’économiel'Industrie, des finances et de l’industrie Secrétariat d’Etat à l’industrie Direction de l’action régionale et de la petite Poste et moyenne industrie Sous direction de la sécurité industrielle Ministère de l’économie, des finances et de l’industrie Secrétariat d’Etat à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Télécommunications • Ireland Department of Enterprise and Employment — • Italy Ministero dell’Industriadell' Industria, del Commercio e dell’Artigianato — dell' Artigianato • Luxembourg Ministère des transports — Transports • Netherlands Staat der Nederlanden — Ministerie van Sociale Zaken en Werksgelegenheid • Austria Bundesministerium für Wirtschaftliche wirtschaftliche Angelegenheiten — • Portugal Under the authority of the Government of Portugal: Instituto Português da Qualidade — • Finland Kauppa- ja teollisuusministeriö/Handels- och industriministeriet — Työministeriö • Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll controll (SWEDAC) — • UK Department of Trade and Industry

DESIGNATED CONFORMITY ASSESSMENT BODIES. The conformity assessment bodies Conformity Assessment Bodies designated by New Zealand to assess products product against the European Community’s 's legislative, regulatory and administrative requirements The conformity assessment bodies Conformity Assessment Bodies designated by the European Community to assess products product against New Zealand’s 's legislative, regulatory and administrative requirements The designated conformity assessment bodies Conformity Assessment Bodies are: [Names Name and details to be inserted][Note: inserted] [Further names and details to be added as required] The designated conformity assessment bodies Conformity Assessment Bodies are: [Names Name and details to be inserted] [Note: Further names and details to be added as required] SECTION III : THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies Conformity Assessment Bodies designated by New Zealand For the conformity assessment bodies Conformity Assessment Bodies designated by the European Community Commission Under the authority of the New Zealand Government:(aGovernment: a) For Certification Bodies: — The • the Joint Accreditation System of Australia and New Zealand (XXX-ANZ) (b) For Testing Laboratories and Inspection Bodies: — • The Testing Laboratory Registration Council of New Zealand — • Belgium Ministère de l’Economie l'Emploi et du Travail Ministerie van Economie — Tewerkstelling en Arbeid • Denmark Direktoratet for Arbejdstilsynet — • Germany Bundesministerium für Arbeit und Sozialordnung — • Greece Υnoυργsío Ανánuυ3ης ⌧⇨⇦⬁⇧🡬🡯🡨⇦ 🕚🡿⮊⇨⇳⬁Ł🡸 ⇩ Ministry of Development — • Spain Ministerio de Industria Industria, Comercio y Energía — Turismo • France Ministère du Travail et des Affaires Sociales et Ministère de l’économiel'Industrie, des finances et de l’industrie Secrétariat d’Etat à l’industrie Direction de l’action régionale et de la petite Poste et moyenne industrie Sous direction de la sécurité industrielle Ministère de l’économie, des finances et de l’industrie Secrétariat d’Etat à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Télécommunications • Ireland Department of Enterprise and Employment — • Italy Ministero dell’Industriadell' Industria, del Commercio e dell’Artigianato — dell' Artigianato • Luxembourg Ministère des transports — Transports • Netherlands Staat der Nederlanden — Ministerie van Volksgezondheid, Welzijn en Sport • Austria Bundesministerium für Wirtschaftliche wirtschaftliche Angelegenheiten — • Portugal Under the authority of the Government of Portugal: Instituto Português da Qualidade — • Finland Kauppa- ja teollisuusministeriö/Handels- och industriministeriet — Työministeriö • Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll controll (SWEDAC) — • UK Department of Trade and Industry

DESIGNATED CONFORMITY ASSESSMENT BODIES. The conformity assessment bodies Conformity Assessment Bodies designated by New Zealand Australia to assess products against the European Community’s legislative, legislative and regulatory and administrative requirements The conformity assessment bodies Conformity Assessment Bodies designated by the European Community to assess products against New ZealandAustralia’s legislative, legislative and regulatory and administrative requirements The designated conformity assessment bodies are: [Names Name and details to be inserted][Noteinserted] [Note : Further names and details to be added as required] The designated conformity assessment bodies are: [Names Name and details to be inserted] [NoteNote : Further names and details to be added as required] SECTION III THE : AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies Conformity Assessment Bodies designated by New Zealand Australia For the conformity assessment bodies Conformity Assessment Bodies designated by the European Community Under the authority of the New Zealand Government:(aGovernment of Australia: a) For Certification Bodies: — The • the Joint Accreditation System of Australia and New Zealand (XXX-XXX- ANZ) (b) For Testing Laboratories and Inspection Bodies: — The • the National Association of Testing Laboratory Registration Council of New Zealand — Authorities, Australia (NATA) · Belgium Ministère de l’Economie l'Emploi et du Travail Ministerie van Economie — Tewerkstelling en Arbeid • Denmark Direktoratet for Arbejdstilsynet — • Germany Bundesministerium für Arbeit und Sozialordnung — • Greece Υnoυργsío Ανánuυ3ης ⌧⇨⇦⬁⇧🡬🡯🡨⇦ 🕚🡿⮊⇨⇳⬁Ł🡸⇩ Ministry of Development — • Spain Ministerio de Industria Industria, Comercio y Energía — Turismo • France Ministère du Travail et des Affaires Sociales et Ministère de l’économiel'Industrie, des finances et de l’industrie Secrétariat d’Etat à l’industrie Direction de l’action régionale et de la petite Poste et moyenne industrie Sous direction de la sécurité industrielle Ministère de l’économie, des finances et de l’industrie Secrétariat d’Etat à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Télécommunications • Ireland Department of Enterprise and Employment — • Italy Ministero dell’Industriadell' Industria, del Commercio e dell’Artigianato — dell' Artigianato • Luxembourg Ministère des transports — Transports • Netherlands Staat der Nederlanden — Ministerie van Sociale Zaken en Werksgelegenheid • Austria Bundesministerium für Wirtschaftliche wirtschaftliche Angelegenheiten — • Portugal Under the authority of the Government of Portugal: Instituto Português da Qualidade — • Finland Kauppa- ja teollisuusministeriö/Handels- och industriministeriet — Työministeriö • Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll controll (SWEDAC) — • UK Department of Trade and Industry

DESIGNATED CONFORMITY ASSESSMENT BODIES. The conformity Conformity assessment bodies designated by New Zealand Australia to assess products against the European CommunityUnion’s legislative, regulatory and administrative requirements The conformity Conformity assessment bodies designated by the European Community Union to assess products against New ZealandAustralia’s legislative, regulatory regu­ latory and administrative requirements The lists of designated conformity assessment bodies are: [Names have been mutually established by the Parties and details to will be inserted][Note: Further names and details to be added as required] maintained by them. The lists of designated conformity assessment bodies are: [Names have been mutually established by the Parties and details to will be inserted] [Note: Further names and details to be added as required] maintained by them. SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II FOR THE PURPOSES OF THIS AGREEMENT For the conformity assessment bodies designated by New Zealand Australia For the conformity assessment bodies designated by the European Community Under the authority Member States of the New Zealand Government:(a) For Certification Bodies: European Union — The Joint Accreditation System Department of Australia Health and New Zealand (XXX-ANZ) (b) For Testing Laboratories and Inspection Bodies: — The Testing Laboratory Registration Council of New Zealand Ageing for the Therapeutic Goods Administration — Belgium Ministère de l’Economie la Santé publique, de l’Environnement et de l’Intégration sociale Ministerie van Economie Volksgezondheid, Leefmilieu en Sociale Integratie For the conformity assessment bodies designated by Australia For the conformity assessment bodies designated by the Member States of the European Union Agence Fédérale des Médicaments et des Produits de Santé – Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten — Bulgaria Държавна агенция за метрологичен и технически надзор — Czech Republic Úřad pro technickou normalizaci, metrologii a státní zkušebnictví — Denmark Direktoratet for Arbejdstilsynet Indenrigs- og Sundhedsministeriet Lægemiddelstyrelsen — Germany Bundesministerium ZLG — Zentralstelle der Länder für Arbeit Gesund­ heitsschutz bei Arzneimitteln und Sozialordnung Medizinpro­ dukten, Bonn ZLS — Zentralstelle der Länder für Sicherheit­ stechnik, München — Estonia Majandus- ja Kommunikatsiooniministeerium — Ireland Department of Health Irish Medicines Board — Greece Υnoυργsío Ανánuυ3ης Ministry of Development Υπουργείο Υγείας και Κοινωνικής Αλληλεγγύης Εθνικός Οργανισμός Φαρμάκων — Spain Ministerio xx Xxxxxxx, Política Social e Igualdad Agencia Española de Industria Medicamentos y Energía Productos Sanitarios — France Ministère de l’économie, la Santé Agence Française de Sécurité Sanitaire des finances et produits de l’industrie Secrétariat d’Etat à l’industrie Direction de l’action régionale et de la petite et moyenne industrie Sous direction de la sécurité industrielle Ministère de l’économie, des finances et de l’industrie Secrétariat d’Etat à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Enterprise and Employment Santé Agence Nationale du Médicament Vétérinaire — Italy Ministero dell’Industriadella Salute – Dipartimento dell’ Inno­ vazione – Direzione Generale Farmaci e Dispositivi Medici — Cyprus The Drugs Council, del Commercio e dell’Artigianato Pharmaceutical Services (Ministry of Health) Veterinary Services (Ministry of Agriculture) For the conformity assessment bodies designated by Australia For the conformity assessment bodies designated by the Member States of the European Union — Latvia Zāļu valsts aģentūra Veselības ministrija — Lithuania Lietuvos Respublikos sveikatos apsaugos ministerija — Luxembourg Ministère de la Santé Division de la Pharmacie et des transports Médicaments — Hungary Országos Gyógyszerészeti Intézet — Malta Direttorat tal-Affarijiet Regolatorji, Awtorità Maltija dwar l-iStandards — Netherlands Staat der Nederlanden Ministerie van Volksgezondheid, Welzijn en Sport Inspectie voor de Gezondheidszorg — Austria Bundesministerium für Wirtschaftliche Angelegenheiten Gesundheit Bundesamt für Sicherheit im Gesundheitswesen — Poland Ministerstwo Zdrowia Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych — Portugal Under INFARMED:I.P. (Autoridade Nacional do Medic­ amento e Produtos de Saúde, I.P.) — Romania Ministerul Sănătății – Departament Dispozitive Medicale — Slovenia Ministrstvo za zdravje Javna agencija Republike Slovenije za zdravila in medicinske pripomočke — Slovakia Úrad pre normalizáciu, metrológiu a skúšobníctvo Slovenskej republiky — Finland Sosiaali- ja terveysministeriö Sosiaali- ja terveysalan lupa- ja valvontavirasto (Xxx­ xxxx) For the authority conformity assessment bodies designated by Australia For the conformity assessment bodies designated by the Member States of the Government of Portugal: Instituto Português da Qualidade — Finland Kauppa- ja teollisuusministeriö/Handels- och industriministeriet European Union — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — UK United Kingdom Medicines and Healthcare products Regulatory Agency SECTION IV PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES Procedures to be followed by Australia in designating conformity assessment bodies to assess products against the European Union’s requirements Procedures to be followed by the European Union in designating conformity assessment bodies to assess products against Australia’s requirements The Therapeutic Goods Administration of the Department of Trade Health and IndustryAgeing will meet the requirements of the Directives listed in Section I, taking into account Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, as amended, insofar as it refers to the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, and be designated for specific categories or classes of devices and conformity assessment procedures. For products covered by Section V, designation will occur on the basis of a confidence- building programme as referred to in point 1.2 of Section V. (1) Conformity assessment bodies will meet the requirements mentioned in the Directives listed in Section I, taking into account Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, as amended, insofar as it refers to the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, and be designated for specific categories or classes of devices and conformity assessment procedures. For products covered by Section V, designation will occur on the basis of a confidence- building programme as referred to in point 1.2 of Section V. (2)

DESIGNATED CONFORMITY ASSESSMENT BODIES. The conformity assessment bodies Conformity Assessment Bodies designated by New Zealand to assess products product against the European Community’s 's legislative, regulatory and administrative requirements The conformity assessment bodies Conformity Assessment Bodies designated by the European Community to assess products product against New Zealand’s 's legislative, regulatory and administrative requirements The designated conformity assessment bodies Conformity Assessment Bodies are: [Names Name and details to be inserted][Note: Further names and details to be added as required] The designated conformity assessment bodies are: [Names and details to be inserted] [Note: Further names to be added as required] The designated Conformity Assessment Bodies are: [Name and details to be to be inserted] [Note: Further names to be added as required] SECTION III : THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II For the conformity assessment bodies Conformity Assessment Bodies designated by New Zealand For the conformity assessment bodies Conformity Assessment Bodies designated by the European Community Under the authority of the New Zealand Government:(aGovernment: (a) For Certification Bodies: — Bodies • The Joint Accreditation System of Australia and New Zealand (XXX-ANZ) (b) For Testing Laboratories and Inspection Bodies: — • The Testing Laboratory Registration Council of New Zealand — • Belgium Ministère de l’Economie des Affaires Economiques Ministerie van Economie — Economische Zaken • Denmark Direktoratet for Arbejdstilsynet — Bygge- og Boligstyrelsen • Germany Bundesministerium für Arbeit und Sozialordnung — • Greece Υnoυργsío Ανánuυ3ης ⌧⇨⇦⬁⇧🡬🡯🡨⇦ 🕚🡿⮊⇨⇳⬁Ł🡸 ⇩ Ministry of Development — • Spain Ministerio de Industria y Energía — Energia • France Ministère de l’économiel'Industrie, des finances et de l’industrie Secrétariat d’Etat à l’industrie Direction de l’action régionale et de la petite Poste et moyenne industrie Sous direction de la sécurité industrielle Ministère de l’économie, des finances et de l’industrie Secrétariat d’Etat à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Télécommunications • Ireland Department of Enterprise and Employment — • Italy Ministero dell’Industriadell' Industria, del Commercio e dell’Artigianato — dell' Artigianato • Luxembourg Ministère des transports — Transports • Netherlands Staat der Nederlanden — Ministerie van Volksgezondheid, Welzijn en Sport • Austria Bundesministerium für Wirtschaftliche wirtschaftliche Angelegenheiten — • Portugal Under the authority of the Government of Portugal: Instituto Português da Qualidade — • Finland Kauppa- ja teollisuusministeriö/Handels- och industriministeriet — teollisuusministeriö • Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll controll (SWEDAC) — • UK Department of Trade and Industry

DESIGNATED CONFORMITY ASSESSMENT BODIES. The conformity Conformity assessment bodies designated by New Zealand australia to assess products against the European CommunityUnion’s legislative, regulatory and administrative requirements The conformity Conformity assessment bodies designated by the European Community Union to assess products against New Zealandaustralia’s legislative, regulatory regu­ latory and administrative requirements The lists of designated conformity assessment bodies are: [Names have been mutually established by the Parties and details to will be inserted][Note: Further names and details to be added as required] maintained by them. The lists of designated conformity assessment bodies are: [Names have been mutually established by the Parties and details to will be inserted] [Note: Further names and details to be added as required] maintained by them. SECTION III THE AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION II FOR THE PURPOSES OF THIS AGREEMENT For the conformity assessment bodies designated by New Zealand australia For the conformity assessment bodies designated by the European Community Under the authority Member States of the New Zealand Government:(a) For Certification Bodies: European Union — The Joint Accreditation System Department of Australia Health and New Zealand (XXX-ANZ) (b) For Testing Laboratories and Inspection Bodies: — The Testing Laboratory Registration Council of New Zealand ageing for the Therapeutic Goods administration — Belgium Ministère de l’Economie la Santé publique, de l’Environnement et de l’Intégration sociale Ministerie van Economie Volksgezondheid, Leefmilieu en Sociale Integratie For the conformity assessment bodies designated by australia For the conformity assessment bodies designated by the Member States of the European Union agence Fédérale des Médicaments et des Produits de Santé – Federaal agentschap voor Geneesmiddelen en Gezondheidsproducten — Bulgaria Държавна агенция за метрологичен и технически надзор — Czech Republic Úřad pro technickou normalizaci, metrologii a státní zkušebnictví — Denmark Direktoratet for Arbejdstilsynet Indenrigs- og Sundhedsministeriet Lægemiddelstyrelsen — Germany Bundesministerium ZLG — Zentralstelle der Länder für Arbeit Gesund­ heitsschutz bei arzneimitteln und Sozialordnung Medizinpro­ dukten, Bonn ZLS — Zentralstelle der Länder für Sicherheit­ stechnik, München — Estonia Majandus- ja Kommunikatsiooniministeerium — Ireland Department of Health Irish Medicines Board — Greece Υnoυργsío Ανánuυ3ης Ministry of Development Υπουργείο Υγείας και Κοινωνικής Αλληλεγγύης Εθνικός Οργανισμός Φαρμάκων — Spain Ministerio xx Xxxxxxx, Política Social e Igualdad agencia Española de Industria Medicamentos y Energía Productos Sanitarios — France Ministère de l’économie, la Santé agence Française de Sécurité Sanitaire des finances et produits de l’industrie Secrétariat d’Etat à l’industrie Direction de l’action régionale et de la petite et moyenne industrie Sous direction de la sécurité industrielle Ministère de l’économie, des finances et de l’industrie Secrétariat d’Etat à l’industrie Direction générale des stratégies industrielles Sous direction de la qualité et de la normalisation — Ireland Department of Enterprise and Employment Santé agence Nationale du Médicament Vétérinaire — Italy Ministero dell’Industriadella Salute – Dipartimento dell’ Inno­ vazione – Direzione Generale Farmaci e Dispositivi Medici — Cyprus The Drugs Council, del Commercio e dell’Artigianato Pharmaceutical Services (Ministry of Health) Veterinary Services (Ministry of agriculture) For the conformity assessment bodies designated by australia For the conformity assessment bodies designated by the Member States of the European Union — Latvia Zāļu valsts aģentūra Veselības ministrija — Lithuania Lietuvos Respublikos sveikatos apsaugos ministerija — Luxembourg Ministère de la Santé Division de la Pharmacie et des transports Médicaments — Hungary Országos Gyógyszerészeti Intézet — Malta Direttorat tal-affarijiet Regolatorji, awtorità Maltija dwar l-iStandards — Netherlands Staat der Nederlanden Ministerie van Volksgezondheid, Welzijn en Sport Inspectie voor de Gezondheidszorg — Austria Bundesministerium für Wirtschaftliche Angelegenheiten Gesundheit Bundesamt für Sicherheit im Gesundheitswesen — Poland Ministerstwo Zdrowia Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych — Portugal Under INFaRMED:I.P. (autoridade Nacional do Medic­ amento e Produtos de Saúde, I.P.) — Romania Ministerul Sănătății – Departament Dispozitive Medicale — Slovenia Ministrstvo za zdravje Javna agencija Republike Slovenije za zdravila in medicinske pripomočke — Slovakia Úrad pre normalizáciu, metrológiu a skúšobníctvo Slovenskej republiky — Finland Sosiaali- ja terveysministeriö Sosiaali- ja terveysalan lupa- ja valvontavirasto (Xxx­ xxxx) For the authority conformity assessment bodies designated by australia For the conformity assessment bodies designated by the Member States of the Government of Portugal: Instituto Português da Qualidade — Finland Kauppa- ja teollisuusministeriö/Handels- och industriministeriet European Union — Sweden Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDACSWEDaC) — UK United Kingdom Medicines and Healthcare products Regulatory agency SECTION IV PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES Procedures to be followed by australia in designating conformity assessment bodies to assess products against the European Union’s requirements Procedures to be followed by the European Union in designating conformity assessment bodies to assess products against australia’s requirements The Therapeutic Goods administration of the Conformity assessment bodies will meet the Department of Trade Health and Industryageing will meet the requirements mentioned in the Directives listed in requirements of the Directives listed in Section I, taking Section I, taking into account Decision No 768/2008/EC into account Decision No 768/2008/EC of the European of the European Parliament and of the Council of 9 July Parliament and of the Council of 9 July 2008 on a 2008 on a common framework for the marketing of common framework for the marketing of products, as products, as amended, insofar as it refers to the modules amended, insofar as it refers to the modules for the for the various phases of the conformity assessment various phases of the conformity assessment procedures procedures and the rules for the affixing and use of and the rules for the affixing and use of the CE the CE conformity marking, and be designated for conformity marking, and be designated for specific specific categories or classes of devices and conformity categories or classes of devices and conformity assessment procedures. For products covered by Section assessment procedures. For products covered by Section V, designation will occur on the basis of a confidence- V, designation will occur on the basis of a confidence- building programme as referred to in point 1.2 of building programme as referred to in point 1.2 of Section V. (1) Section V. (2) (1) Presumption of competence is following successful completion of confidence-building for Section V devices.