PENAMBAHBAIKAN SURAT PEKELILING PIHAK BERKUASA PERANTI PERUBATAN BIL 2/2014 (SEMAKAN 5): PENILAIAN PEMATUHAN BAGI PERANTI PERUBATAN YANG TELAH DILULUSKAN PIHAK BERKUASA NEGARA LAIN YANG DIIKTIRAF
MDA ingin memaklumkan bahawa Surat Pekeliling PBPP Bil 2/2014 telah ditambahbaik berkuatkuasa 25 April 2022. Penambahbaikan versi Semakan 5 pada Appendix 1 surat pekeliling adalah merujuk kepada perkara berikut:
1. Table 1: Recognised foreign regulatory authorities and notified bodies:
Re-addition of EC Certification (CE Marking) against EU MDD, EU IVDD and EU AIMDD, as below:
For general medical device:
- Annex II Section 3 or Annex V of MDD (for Class IIA)
- Annex II Section 3 or Annex III coupled with Annex V of MDD (for Class IIB)
- Annex II Section 3 and 4 of MDD (for Class III)
- Annex II Section 3 and 4 of AIMDD (for active implantable medical device)
For IVD medical device:
- Annex IV (Including Section 4 and 6) of IVDD (for List A IVD)
- Annex IV (excluding Section 4 and 6) or Annex V coupled with Annex VII of IVDD (for List B and self-testing IVD)
- Annex III, EC declaration of conformity (Section 1 to 5 of Annex III). Applicable for only Class B IVD medical device in accordance with Medical Device Regulation 2012;
2. Annex A: Conformity Assessment Report Template:
Improvement on Common Submission Dossier Template (CSDT) elaboration under 3) Conformity Assessment of Technical Documentation.
Surat pekeliling boleh dimuat turun dari laman sesawang MDA, dan menerusi pautan berikut KLIK DISINI.
Ketua Eksekutif
Pihak Berkuasa Peranti Perubatan
25 April 2022
