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Forms, procedures, policies and fees for medical device certification. Every document opens the current revision on maltaca.com.
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- Medical devices · 10
- PDFFR.MED.165List of Standard Fees According to Regulation (EU) 2017/745Medical devices
- ZIPFormsApplication FormsMedical devices
- DOCXFR.MED.90(EU) 2017/745 Regulation Product Conformity Assessment AgreementMedical devices
- PDFFR.MED.63Medical Devices General TermsMedical devices
- PDFPR.MED.26Medical Devices Certificate and CE Mark Usage ProcedureMedical devices
- DOCXFR.MED.51Change Notification FormMedical devices
- DOCXFR.MED.206Structured Dialogue Application Form and Meeting MinutesMedical devices
- DOCXFR.MED.164List of SubcontractorsMedical devices
- PDFFR.MED.176List of Subsidiaries and Branch OfficesMedical devices
- PDFGuidelineAssessment Guideline for MDRMedical devices
- General · 5
- PDFPR.04Assessment of Complaints and Appeals ProcedureGeneral
- DOCXFR.02Feedback Form: Complaint, Appeal, Suggestion, Information RequestGeneral
- PDFFR.10Confidentiality and Impartiality CommitmentGeneral
- PDFFR.34External Head of Audit Team, Site Auditor, Product Reviewer and Clinical Specialist Service AgreementGeneral
- PDFFR.44Committee Members Confidentiality and Impartiality AgreementGeneral
- Policies · 7
- PDFFR.250MCA Ethics CodePolicies
- PDFFR.251Malta Conformity Assessment PoliciesPolicies
- PDFFR.252Confidentiality and Impartiality Commitment of Malta Conformity Assessment Ltd.Policies
- PDFFR.306Declaration of Interest: General ManagerPolicies
- PDFFR.306Declaration of Interest: Deputy General ManagerPolicies
- PDFFR.306Declaration of Interest: Medical Devices Department ManagerPolicies
- PDFFR.306Declaration of Interest: Quality Manager / Quality Management RepresentativePolicies