Annex 8 Table 1: the arrangement of the product (Medical Device) registration application file:

Transcription

1 Annex 8 Table 1: the arrangement of the product (Medical Device) registration application file: Attachment Required Documents Application Form A The application to place a medical device on the U A E market must be made by the device manufacturer or its authorized representative in country of origin, signed and stamped by the company Regulatory Approval B C 1.Free Sale certificate or certificates, documentation and letters of regulatory approval (attested and authenticated by UAE Embassy) and C E certification/ clearance to manufacture, sell, import and export the medical device from competent authority in Export country 2.All relevant documents, summary data and objective evidence which have been used to obtain approval or clearance, if available; Note: All certificates, documentation and letters of regulatory approval/clearance to manufacture, sell, import and export the medical device to UAE Post-market requirement / vigilance system and risk assessment) Provide evidence of established procedures and systems for Distribution Records, Complaint Handling, Adverse Incident Reporting and Recall Status of device distribution D list of countries where it is marketed, details of the regulatory status (e.g. marketing approval, product recall, product ban, etc.) obtained in each country, a summary of the mandatory reported problems with the device since the introduction of the device in the market. Device Information E 1. Intended Use 2. Indications 3. Instructions of Use 4. Contraindications 5. Warnings 6. Precautions 7. Potential Adverse Events 8. Device Labeling 9. Alternative Therapy 10. Device labeling which include physicians manual, pack labeling and promotional material

2 11. A general description of the device and detailed description of the device attributes; Labeling F Three copies (artwork) of the each product Packaging, labeling and promotional material Labeling and Packaging must have: - the product name, name and address of the company printed in English and/or Arabic, - manufacturing date and/or expiration date. - For single use medical devices must be labeled on outer pack label with SINGLE USE. Declaration of Conformity / Evidence of Conformity to Essential principles **G H 1. Manufacturer s declaration that the medical device complies with the quality, safety and effectiveness requirements. Any certification to demonstrate this compliance should also be submitted, together with any summary technical files containing objective evidence on the safety and effectiveness of the medical device; 2. Any declaration of product conformity to appropriate product certification. For example, CE mark; Copies of certification and document certifying conformity to appropriate quality systems in production and design.(e.g. EC Design Examination Certificate) 3. Fill the Checklist appended as Annex 7 Safety and effectiveness data H.1: Safety and Effectiveness Data H.2: Risk Assessment H.3: Pre-clinical and clinical studies H.4: Biocompatibility

3 H.5 special requirements For Devices Containing Biological Material H.6: Literature studies I J Manufacturing Process Special requirements for Medical Devices manufactured from or incorporating viable or non-viable animal tissue or their derivative(s)./ If devices contain biological materials, copies of documented validated manufacturing processes and certification of appropriate veterinary controls and surveillance adapted to the intended use of the materials; Table 2: the required attachment per Device Class: Class I/ General IVD A Class I / General IVD (class A) (Sterile and/or with Measuring Function) Class II/ Class B IVD Class III/ class C IVD/ Self-testing IVD Class IV/ Class D IVD A A A A A B B B B B Not Applicable Not Applicable C C C Not Applicable Not Applicable D D D E 1 E 1 E 1-8 E 1-11 E 1-11 F F F F F G G Self Declaration F. Self Declaration G. All certificates and documents certifying conformity to the aspects of manufacture relating to sterility and metrology G G G

4 Not Applicable Not Applicable Not Applicable H H Not Applicable Not Applicable Not Applicable I I

5 CLASS ANNEX (according to EU Directive) TYPE of Certificate Declaration of Conformity by Manufacturer per Product Family Notified Body Product Production Notes Class I Annex VII NA NA NA NA Fullfillment of Essential Requirements can be demonstrated by a Full Quality System Class IIa Annex II Full Quality Assurance system without Part 4 NA or Annex IV EC verification (according to Annex VII) or Annex V Production Quality Assurance (according to Annex VII) NA Class IIb or Annex VI Product Quality Assurance (according to Annex VII) NA Full Quality Assurance system Annex II without Part 4 NA or Annex III Type Examination NA NA + Annex IV + EC Verification or Annex III Type Examination NA NA + Production Quality + Annex V Assurance NA or Annex III Type Examination NA NA + Annex VI + Product Quality Assurance NA Class III Annex II Full Quality Assurance system NA Examination of the design of and Annex II part 4 mandatory the product with NB certificate NA NA or Annex III Type Examination NA NA + Annex IV + EC Verification or Annex III Type Examination NA NA + Annex V + Production Quality Assurance NA