Policy, Code & Standard Division

FUNCTIONS OF POLICY, CODE AND STANDARD DIVISION

- Develop, plan, coordinate and implement;-

i - policy development and legal documents such as rules and regulations relating to the control of medical devices under the Medical Devices Act 2012 (Act 737),

ii - the development of guidance documents, codes and standards relating to the control of medical devices under the Medical Device Act 2012 (Act 737) and its rules in more detail,

iii - development of GLP recognized laboratory

- Develop, plan, coordinate and implement activities pertaining to multilateral cooperation and relationship between agencies within and outside the country,

- Develop, plan, coordinate and implement activities pertaining to industrial assistance

- Develop, plan, coordinate and implement compliance monitoring activities against legal requirements under Act 737 through audits and inspection.

The Policy, Code & Standard Division is divided into 2 branches:

i- Policy & Industrial Assistance Branch consisting of 3 units namely International Policy & International Unit, Code & Standard Development Unit and Industrial Assistance Unit,

ii- Compliance Audit Branch conducting CAB audit activities, product and premise quality management and regulatory audit.


Compliance Branch

COMPLIANCE BRANCH

Background

The Compliance Branch formerly known as the Audit Branch was established in 2012.  It is operated under the Policy, Code and Standards Division, Medical Device Authority (MDA).

Functions

To ensure that the establishment and Conformity Assessment Body (CAB) continuously comply with the Act 737, Medical Device Regulation, condition of license / registration and other directives set by the MDA through the inspections

Types of inspections conducted as per below;

Inspection on CAB:

  1. Pre-registration Inspection – Conducted on a company who wish to register as a CAB in Malaysia to ensure they are comply to Act 737 and Fourth Schedule of MDR 2012 prior to registration
  2. Surveillance Inspection – Conducted on registered CAB from time to time to ensure CAB continuously complies to condition of registration, CAB’s QMS is implemented according to Malaysia Regulatory Requirements and information submitted in the online system (MeDC@St) is up to date
  3. Witness / Observe Inspection – Conducted on auditors of registered CAB from time to time to verify the CAB’s ability to assign auditors based on registered scope / code, adequacy  of the auditor’s auditing practices against Malaysia Regulatory Requirements and auditor ability to generate reliable audit reports.

Inspection on Establishment

  1. Surveillance Inspection – Conducted from time to time on licensed establishment (manufacturer / authorised representative/ importer / distributor) to ensure the establishment complies to conditions of license, QMS is established and implemented according to Malaysia Regulatory Requirements and information submitted in online system (MeDC@St) is up to date

Terjemahan kandungan di atas

PEMANTAUAN PEMATUHAN

Latar Belakang

Cawangan Pematuhan yang dahulunya dikenali sebagai Cawangan Audit telah ditubuhkan pada tahun 2012.  Ia dikendalikan dibawah Bahagian Dasar, Kod dan Standard, Pihak Berkuasa Peranti Perubatan (PBPP)

Fungsi

Memastikan Establismen dan Badan Penilaian Pematuhan (CAB) mematuhi keperluan Akta 737, peraturan peralatan perubatan, syarat lesen/pendaftaran dan arahan lain yang ditetapkan oleh MDA secara berterusan melalui pemeriksaan

Jenis pemeriksaan yang dijalankan seperti di bawah;

Pemeriksaan ke atas CAB

  1. Pemeriksaan Pra-Pendaftaran – dijalankan ke atas syarikat yang ingin mendaftar sebagai CAB di Malaysia bagi memastikan mereka mematuhi Akta 737 dan jadual keempat MDR 2012 sebelum pendaftaran
  2. Pemeriksaan Surveilan – Dijalankan di atas CAB berdaftar dari semasa ke semasa bagi memastikan CAB mematuhi syarat pendaftaran, sistem pengurusan kualiti yang dilaksanakan mengikut keperluan regulatori Malaysia secara berterusan.  Selain itu, maklumat yang dikemukakan dalam sistem dalam talian (MeDC@St) betul dan dikemaskini
  3. Pemeriksaan Penyaksian – Dijalankan ke atas Juruaudit CAB berdaftar dari semasa ke semasa untuk mengesahkan keupayaan CAB untuk menugaskan Juruaudit berdasarkan skop/kod yang berdaftar, kompetensi Juruaudit terhadap keperluan regulatori Malaysia dan keupayaan juruaudit untuk mengeluarkan laporan audit yang konsisten dan boleh dipercayai

Pemeriksaan ke atas Establismen

  1. Pemeriksaan Surveilan– dijalankan dari semasa ke semasa ke atas establismen berlesen (pengilang/wakil diberi kuasa/pengimport/pengedar) untuk memastikan establismen mematuhi syarat-syarat lesen, sistem pengurusan kualiti telah diwujudkan dan dilaksanakan mengikut keperluan regulatori dan maklumat yang dikemukakan dalam sistem atas talian (MeDC@St) adalah betul dan dikemaskini

Industrial Support

The carried out activities are;

Certificate of free sales (CFS) and Manufacturing certificate

To provides a service to medical devices industries with handles application of Certificate of Free Sale (CFS) and Manufacturing Certificate (MC). This certification is intended to help medical device industries engaged in the exportation.

Involvement with the ministry/department/others agency

Participated in a series of discussions with the relevant agencies to discuss new matters and resolve issues related to medical devices in Malaysia.




Print