BADAN PENILAIAN PEMATUHAN (CAB) | CONFORMITY ASSESSMENT BODY (CAB)

Apakah itu Badan Penilaian Pematuhan (CAB) di bawah Akta Peranti Perubatan Malaysia 2012 (Akta 737) dan Peraturan-Peraturan Peranti Perubatan 2012? | What is a Conformity Assessment Body (CAB) under the Malaysia Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012?
Apakah tugas utama Badan Penilaian Pematuhan (CAB)? | What are the main tasks of a Conformity Assessment Body (CAB)?
Apakah perkhidmatan yang disediakan oleh Badan Penilaian Pematuhan (CAB)? | What services are provided by Conformity Assessment Bodies (CABs)?
Bagaimanakah Badan Penilaian Pematuhan (CAB) didaftarkan di Malaysia? | How are Conformity Assessment Bodies (CABs) registered in Malaysia?
Adakah Badan Penilaian Pematuhan (CAB) satu-satunya entiti yang bertanggungjawab untuk penilaian dan pensijilan peranti perubatan? | Are Conformity Assessment Bodies (CABs) the only entities responsible for assessment and certification of medical devices?
Bagaimanakah pengilang peranti perubatan, wakil yang sah, pengimport, atau pengedar memilih Badan Penilaian Pematuhan (CAB) yang sesuai? | How can a medical device manufacturer, authorized representative, importer, or distributor choose a suitable Conformity Assessment Body (CAB)?
Bolehkah Badan Penilaian Pematuhan (CAB) beroperasi di peringkat antarabangsa? | Can Conformity Assessment Bodies (CABs) operate internationally?
Berapa kerap pengilang peranti perubatan, wakil yang sah, pengimport, dan pengedar perlu berurusan dengan Badan Penilaian Pematuhan (CAB)? | How often are medical device manufacturers, authorized representatives, importers, and distributor required to engage with Conformity Assessment Bodies (CABs)?
Apakah peranan yang dimainkan oleh Badan Penilaian Pematuhan (CAB) dalam pengawasan pasca-pemasaran? | What role do Conformity Assessment Bodies (CABs) play in post-market surveillance?
Bagaimanakah Akta Peranti Perubatan Malaysia 2012 (Akta 737) memastikan kecekapan Badan Penilaian Pematuhan (CAB)? | How does the Malaysia Medical Device Act 2012 (Act 737) ensure the competence of Conformity Assessment Bodies (CABs)?
Apakah jenis-jenis Badan Penilaian Pematuhan (CAB) yang berdaftar di bawah Akta 737? | What are the different types of Conformity Assessment Bodies (CABs) registered under the Act 737?
Bagaimanakah saya boleh mengesahkan sama ada sebuah Badan Penilaian Pematuhan (CAB) adalah sah dan berdaftar oleh MDA? | How can I verify if a Conformity Assessment Body (CAB) is legitimate and registered by MDA?
Bolehkah pengilang, wakil yang sah, pengimport, atau pengedar memilih mana-mana Badan Penilaian Pematuhan (CAB) untuk penilaian peranti perubatan mereka, atau adakah terdapat sekatan? | Can a manufacturer, authorized representative, importer, or distributor choose any Conformity Assessment Body (CAB) for their medical device assessment, or are there limitations?
Bolehkah Badan Penilaian Pematuhan (CAB) mengenakan yuran untuk perkhidmatan mereka? | Can a Conformity Assessment Body (CAB) charge fees for their services?
Bolehkah Badan Penilaian Pematuhan (CAB) memansuhkan Sijil Penilaian Pematuhan? | Can a Conformity Assessment Body (CAB) revoke a Conformity Assessment Certificate?
Adakah Badan Penilaian Pematuhan (CAB) perlu memelihara sebarang akreditasi khusus? | Are Conformity Assessment Bodies (CABs) required to maintain any specific accreditations?
Bolehkah pengilang peranti perubatan, wakil yang sah, pengimport, atau pengedar menukar Badan Penilaian Pematuhan (CAB) semasa proses pensijilan? | Can a medical device manufacturer, authorized representative, importer, or distributor switch Conformity Assessment Bodies (CABs) during the certification process?
Adakah terdapat garis panduan khusus untuk maklumat yang patut dimasukkan dalam Sijil Penilaian Pematuhan? | Are there specific guidelines for the information that should be included in a Conformity Assessment Certificate?
Bolehkah Badan Penilaian Pematuhan (CAB) memberikan bantuan kepada pengilang, wakil yang sah, pengimport, atau pengedar dalam menyediakan dokumentasi mereka? | Can Conformity Assessment Bodies (CABs) provide assistance to manufacturers, authorized representatives, importers, or distributors in preparing their documentation?
Berapa kerap Badan Penilaian Pematuhan (CAB) diperiksa atau dikaji semula untuk pematuhan mereka sendiri? | How frequently are Conformity Assessment Bodies (CABs) inspected or reviewed for their own compliance?
Adakah terdapat kelayakan atau keperluan khusus untuk individu yang bekerja di dalam Badan Penilaian Pematuhan (CAB)? | Are there specific qualifications or requirements for individuals working within Conformity Assessment Bodies (CABs)?
Bolehkah pengilang, wakil yang sah, pengimport, atau pengedar mencabar keputusan yang dibuat oleh Badan Penilaian Pematuhan (CAB) mengenai pematuhan peranti mereka? | Can a manufacturer, authorized representative, importer, or distributor challenge a decision made by a Conformity Assessment Body (CAB) regarding their device's conformity?
Adakah Badan Penilaian Pematuhan (CAB) bertanggungjawab untuk menilai data klinikal berkaitan dengan peranti perubatan? | Are Conformity Assessment Bodies (CABs) responsible for evaluating clinical data related to medical devices?
Bagaimanakah Akta Peranti Perubatan 2012 (Akta 737) menangani konflik kepentingan di dalam Badan Penilaian Pematuhan (CAB)? | How does the Medical Device Act 2012 (Act 737) address conflicts of interest within Conformity Assessment Bodies (CABs)?
Bolehkah Badan Penilaian Pematuhan (CAB) menyediakan perkhidmatan perundingan kepada pengilang, wakil yang sah, pengimport, atau pengedar untuk membantu mereka memenuhi keperluan peraturan? | Can Conformity Assessment Bodies (CABs) provide consulting services to manufacturers, authorized representatives, importers, or distributors to help them meet regulatory requirements?
Bagaimanakah Badan Penilaian Pematuhan (CAB) menyelaraskan diri dengan peraturan dan piawaian yang berkembang? | How do Conformity Assessment Bodies (CABs) stay updated with evolving regulations and standards?
Apakah yang berlaku jika Badan Penilaian Pematuhan (CAB) gagal memenuhi kewajipannya atau melanggar peraturan? | What happens if a Conformity Assessment Body (CAB) fails to meet its obligations or violates regulations?
Bolehkah Badan Penilaian Pematuhan (CAB) beroperasi sebagai entiti yang bebas, atau perlu berkait rapat dengan organisasi yang lebih besar? | Can a Conformity Assessment Body (CAB) operate as an independent entity, or does it need to be affiliated with a larger organization?
Bagaimanakah pengilang, wakil yang sah, pengimport, dan pengedar boleh menangani isu-isu jika mereka tidak berpuas hati dengan perkhidmatan yang disediakan oleh Badan Penilaian Pematuhan (CAB)? | How can manufacturers, authorized representatives, importers, and distributors address issues if they are dissatisfied with the services provided by a Conformity Assessment Body (CAB)?
Bolehkah Badan Penilaian Pematuhan (CAB) menyediakan perkhidmatan penilaian segera untuk peranti perubatan dalam keadaan yang memerlukan segera? | Can Conformity Assessment Bodies (CABs) provide expedited assessment services for medical devices in urgent situations?
Bolehkah Badan Penilaian Pematuhan (CAB) melakukan penilaian jarak jauh, terutamanya dalam kes-kes di mana lawatan ke tapak menjadi sukar? | Can Conformity Assessment Bodies (CABs) conduct remote assessments, especially in cases where on-site visits are challenging?
Adakah terdapat keperluan khusus untuk melaporkan kejadian atau insiden yang berkaitan dengan peranti perubatan kepada Badan Penilaian Pematuhan (CAB)? | Are there specific requirements for reporting adverse events or incidents related to medical devices to Conformity Assessment Bodies (CABs)?
Bolehkah Badan Penilaian Pematuhan (CAB) memberikan bantuan kepada pengilang, wakil yang sah, pengimport, atau pengedar dalam persediaan untuk keperluan peraturan yang dikenakan oleh MDA? | Can a Conformity Assessment Body (CAB) provide assistance to manufacturers, authorized representatives, importers, or distributors in preparing for regulatory requirements imposed by MDA?
Bolehkah pengilang, wakil yang sah, pengimport, atau pengedar meminta penilaian semula oleh CAB yang berbeza jika mereka tidak bersetuju dengan hasil penilaian asal? | Can a manufacturer, authorized representative, importer, or distributor request a re-assessment by a different Conformity Assessment Body (CAB) if they disagree with the results of the initial assessment?
Adakah terdapat sebarang had bagi kawasan geografi di mana Badan Penilaian Pematuhan (CAB) boleh beroperasi? | Are there any limitations on the geographic areas where Conformity Assessment Bodies (CABs) can operate?
Bolehkah Badan Penilaian Pematuhan (CAB) juga terlibat dalam pensijilan kakitangan untuk tugas berkaitan peranti perubatan? | Can a Conformity Assessment Body (CAB) also be involved in the certification of personnel for medical device-related tasks?
Bagaimanakah Badan Penilaian Pematuhan (CAB) boleh memastikan kerahsiaan maklumat sensitif yang dikongsi semasa penilaian? | How can Conformity Assessment Bodies (CABs) ensure the confidentiality of sensitive information shared during assessments?
Bolehkah Badan Penilaian Pematuhan (CAB) menawarkan garis masa penilaian dipercepatkan dengan bayaran tambahan? | Can a Conformity Assessment Body (CAB) offer expedited assessment timelines for an additional fee?
Adakah terdapat keperluan untuk Badan Penilaian Pematuhan (CAB) menyimpan rekod aktiviti penilaian mereka? | Are there requirements for Conformity Assessment Bodies (CABs) to maintain records of their assessment activities?
Bagaimana Badan Penilaian Pematuhan (CAB) menangani kes di mana reka bentuk atau kegunaan yang dimaksudkan untuk peranti perubatan berubah selepas pensijilan awal? | How do Conformity Assessment Bodies (CABs) handle cases where a medical device's design or intended use changes after initial certification?
Bolehkah Badan Penilaian Pematuhan (CAB) memberi panduan tentang keperluan pelabelan dan pembungkusan untuk peranti perubatan? | Can Conformity Assessment Bodies (CABs) provide guidance on labeling and packaging requirements for medical devices?
Bagaimanakah Badan Penilaian Pematuhan (CAB) mengesahkan ketulenan dan ketepatan dokumentasi teknikal yang dikemukakan oleh pengeluar? | How do Conformity Assessment Bodies (CABs) verify the authenticity and accuracy of technical documentation submitted by manufacturers?
Adakah Badan Penilaian Pematuhan (CAB) terlibat dalam penilaian perisian atau aplikasi kesihatan digital yang disepadukan ke dalam peranti perubatan? | Are Conformity Assessment Bodies (CABs) involved in the evaluation of software or digital health applications integrated into medical devices?
Bolehkah Badan Penilaian Pematuhan (CAB) memberikan penilaian awal kepada pengilang, wakil yang diberi kuasa, pengimport, atau pengedar sebelum pensijilan formal? | Can Conformity Assessment Bodies (CABs) provide manufacturers, authorized representatives, importers, or distributors with a preliminary assessment of their medical device before formal certification?
Adakah terdapat peruntukan untuk membuat rayuan terhadap keputusan yang dibuat oleh Badan Penilaian Pematuhan (CAB)? | Are there provisions for appealing the decisions made by Conformity Assessment Bodies (CABs)?
Bolehkah Badan Penilaian Pematuhan (CAB) menawarkan latihan kepada pengilang, wakil yang diberi kuasa, pengimport, atau pengedar mengenai keperluan-keperluan undang-undang dan prosedur penilaian? | Can a Conformity Assessment Body (CAB) offer training to manufacturers, authorized representatives, importers, or distributors on regulatory requirements and assessment procedures?
Bagaimanakah Badan Penilaian Pematuhan (CAB) menangani situasi di mana peranti perubatan dihasilkan oleh pihak ketiga (OEM atau pengilang kontrak) bagi pihak pengilang? | How do Conformity Assessment Bodies (CABs) address situations where a medical device is manufactured by a third party (OEM or contract manufacturer) on behalf of the manufacturer?
Bolehkah Badan Penilaian Pematuhan (CAB) bekerjasama dengan CAB antarabangsa lain untuk penilaian yang merentasi sempadan? | Can a Conformity Assessment Body (CAB) collaborate with other international CABs for assessments that cross borders?
Bagaimanakah Badan Penilaian Pematuhan (CAB) dipantau untuk prestasi dan pematuhan berterusan mereka? | How are Conformity Assessment Bodies (CABs) monitored for their ongoing performance and compliance?
Bolehkah Badan Penilaian Pematuhan (CAB) menyediakan pengilang dengan senarai keperluan sebelum memulakan proses penilaian? | Can Conformity Assessment Bodies (CABs) provide manufacturers with a list of requirements before beginning the assessment process?