Apakah perkhidmatan yang disediakan oleh Badan Penilaian Pematuhan (CAB)? | What services are provided by Conformity Assessment Bodies (CABs)?

CAB menawarkan pelbagai perkhidmatan kepada pengilang peranti perubatan, wakil yang sah, pengimport, dan pengedar, termasuk: (1) Semakan Fail Teknikal: Menyemak dokumentasi teknikal yang dihantar oleh pengilang dan/atau wakil yang sah untuk menunjukkan pematuhan kepada keperluan peraturan. (2) Audit Sistem Kualiti: Mengaudit kemudahan pembuatan dan/atau pertubuhan untuk menilai pematuhan kepada piawaian sistem pengurusan kualiti. Ujian dan Analisis: Melakukan ujian untuk menilai keselamatan, prestasi, dan kebolehpercayaan peranti perubatan. (3) Pensijilan: Mengeluarkan sijil yang menunjukkan bahawa peranti perubatan mematuhi piawaian dan peraturan yang berkaitan. (4) Penilaian: Melakukan penilaian terhadap kemudahan pembuatan dan/atau pertubuhan melalui lawatan pemantauan untuk memastikan pematuhan berterusan.

 

CABs offer a range of services to medical device manufacturers, authorized representatives, importers, and distributors, including: (1) Technical File Review: Reviewing technical documentation submitted by manufacturers and/or authorized representative to demonstrate conformity with regulatory requirements. (2) Quality System Audits: Auditing manufacturing and/or establishment facilities to assess compliance with quality management system standards. Testing and Analysis: Performing tests to evaluate the safety, performance, and reliability of medical devices. (3) Certification: Issuing certificates indicating that a medical device conforms to the relevant standards and regulations. (4) Assessments: Conducting assessments of manufacturing and/or establishment facilities through surveillance visits to ensure ongoing compliance.