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.


Audit Unit

COMPLIANCE AUDIT

Background

Compliance Audit Branch was established in 2012 and placed under the Policy, Code and Standards Division, Medical Device Authority (MDA). There are 3 officers placed under this branch to carry out the compliance audit on the establishment and the Conformity Assessment Body (CAB).

Functions and objectives

The function and objective of the compliance audit branch is to ensure that the establishment and CAB continuously comply with the regulatory and any other requirements set by the MDA. Types of audits conducted as per below;

Types of Audit:

  1. Audit on CAB
  2. Registration Audit – Audit conducted on the Conformity Assessment Body (CAB) for the purpose of registration with the Medical Device Authority (MDA)
  3. Surveillance Audit – Audit conducted for the purpose of monitoring the registered CAB
  4. Witness / Observe Audit – Audit conducted on auditors of registered CAB
  5. Audit / Inspection on Establishment
  6. Surveillance Inspection - Inspection conducted for the purpose of monitoring the establishment licensed by MDA. The audit covers the scope of ISO 13485 for the manufacturer, and the scope of the Good Distribution Practice of Medical Device (GDPMD) for the audit on the authorized representative (AR), distributors and importers.

Terjemahan kandungan di atas

AUDIT PEMATUHAN

Latar Belakang

Cawangan audit pematuhan telah ditubuhkan pada tahun 2012 dan diletakkan di bawah Bahagian Dasar, Kod dan Standard, Pihak Berkuasa Peranti Perubatan (PBPP). Terdapat 3 orang pegawai ditugaskan di bawah cawangan ini bagi menjalankan kerja-kerja audit pematuhan ke atas establismen dan Badan Penilaian Pematuhan (CAB).

Fungsi dan objektif

Fungsi dan objektif cawangan audit pematuhan adalah bagi memastikan establismen dan CAB sentiasa mematuhi keperluan regulatori dan apa-apa keperluan yang telah ditetapkan oleh PBPP. Berikut merupakan jenis audit yang dijalankan.

Jenis Audit yang dijalankan:

  1. Audit ke atas CAB:
  2. Audit Pendaftaran – Audit yang dijalankan ke atas CAB bagi tujuan pendaftaran dengan PBPP.
  3. Audit Survelan – Audit yang dijalankan bagi tujuan pemantauan ke atas CAB yang berdaftar dengan PBPP

                  iii. Witness/Observe Audit – Audit Penyaksian ke atas auditor dari CAB yang berdaftar

  1. Audit ke atas establishmen
  2. Audit Survelan – Audit yang dijalankan bagi tujuan pemantauan terhadap establismen yang berlesen dengan PBPP. Audit ini merangkumi skop ISO 13485 bagi audit / pemeriksaan ke atas pengeluar, dan skop Good Distribution Practice of Medical Device (GDPMD) bagi audit / pemeriksaan ke atas wakil diberi kuasa (AR), pengedar dan pengimport.

 


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.




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