Apakah tugas utama Badan Penilaian Pematuhan (CAB)? | What are the main tasks of a Conformity Assessment Body (CAB)?

CAB memainkan peranan kritikal dalam rangka kerja peraturan untuk peranti perubatan. Tugas utama mereka termasuk:

(1) Penilaian Pematuhan: CAB menilai dokumentasi teknikal, reka bentuk, proses pembuatan, dan ciri-ciri prestasi peranti perubatan untuk memastikan pematuhan dengan piawaian dan peraturan yang berkaitan.

(2) Audit dan Penilaian: CAB boleh menjalankan audit dan penilaian terhadap pengilang peranti perubatan, wakil yang sah, pengimport, dan pengedar untuk mengesahkan bahawa mereka mematuhi sistem pengurusan kualiti (ISO 13485 dan Amalan Pengedaran Baik Peranti Perubatan, GDPMD) berdasarkan keperluan peraturan tertentu.

(3) Ujian dan Penilaian: CAB boleh melakukan ujian dan analisis terhadap peranti perubatan untuk menilai keselamatan, prestasi, dan keberkesanannya.

(4) Pensijilan dan Pengeluaran Sijil Penilaian Pematuhan: Berdasarkan penilaian yang berjaya, CAB mengeluarkan Sijil Penilaian Pematuhan yang menunjukkan bahawa peranti perubatan memenuhi piawaian dan peraturan yang diperlukan.

CABs play a critical role in the regulatory framework for medical devices. Their main tasks include:

(1) Conformity Assessment: CABs evaluate the technical documentation, design, manufacturing processes, and performance characteristics of medical devices to ensure compliance with the relevant standards and regulations.

(2) Audits and Assessments: CABs may conduct audits and assessments of medical device manufacturers, authorized representatives, importers, and distributors to verify that they adhere to quality management systems (ISO 13485 and Good Distribution Practice of Medical Devices, GDPMD) based on specific regulatory requirements.

(3) Testing and Evaluation: CABs may perform testing and analysis of medical devices to assess their safety, performance, and effectiveness.

(4) Certification and Issuance of Conformity Assessment Certificates: Based on successful assessment, CABs issue Conformity Assessment Certificates, indicating that a medical device meets the required standards and regulations.