ON-SITE AUDIT FOR HALAL

Khairunnisa binti Che OmarAssistant Director

Halal Management Division

FOR HALAL MEDICAL DeVICE

PROSES PENSIJILAN

Penerimaan borang

Semakan dokumen

Pengeluaran surat caj

Terima bayaran

Pemeriksaan Premis/AuditPemeriksaan Premis/Audit

Laporan Pemeriksaan

Jawatankuasa Panel Halal

Pengeluaran Sijil Halal

Pemantauan dan Penguatkuasaan

WHAT IS HALAL?Halal refers to things or actions permitted

by the Shariah law or fatwa.

raw material

WHY HALAL MEDICAL DEVICE?

Demand

From the industry

From importing country

Value

Value added element; Halal as symbol of quality &

lifestyle choice

confidence

Aid in increasing confidence to Muslim/Non Muslim

Customers

Greater market share, no Greater market share, no loss of non Muslim market

Who can apply?

MANUFACTURER/ PRODUCER

BRAND OWNER / OEM

REPACKER

Syarikat hendaklah berdaftar dengan Suruhanjaya Syarikat Malaysia;

PBTMempunyai lesen operasi yang masih sah

daripada Pihak Berkuasa Tempatan;

SYARATSYARATSYARATSYARAT----SYARAT PEMOHONSYARAT PEMOHONSYARAT PEMOHONSYARAT PEMOHON

ROC

DEDICATED HALALPengeluar/pengilang/syarikat hendaklah

mengeluar produk halal sahaja;Memohon untuk semua produk yang

dihasilkan

Mempunyai sekurang-kurangnya 2 orang pekerja Islam warganegara Malaysia;

MUSLIM WORKERS

Fully operated

Beroperasi sepenuhnya sebelum membuat permohonan.

GHP

Mengamalkan kod etika pekerja dan amalan kesihatan yang baik ( GHP )

SYARATSYARATSYARATSYARAT----SYARAT PEMOHONSYARAT PEMOHONSYARAT PEMOHONSYARAT PEMOHON

Penyediaan, pengendalian, pemprosesan, pembungkusan, peralatan, pengangkutan atau pemindahan

GMP

Alat penyembahan agama tidak dibenarkan di dalam premis/kawasan pemprosesan

ELEMeNT OF WORSHIP

Perlu membangunkan Halal Assurance System (HAS) / Internal HalalControl System (IHCS)

MHMS

pengangkutan atau pemindahanhendaklah bersih dan halal ataumengamalkan amalan pengilangan yang baik (GMP)

Establishment

REGISTERED PRODUCTS

Medical Device shall have a valid registration certificate or a letter

of exemption from registration requirements from MDA

MEDICAL DEVICE SCHEME Meet the criteria

There is a doubt as source of ingredients/ raw materials :

possible from halal or non halal (Animal/Alcohol)

Directly contact with human Example; surgical mesh and

bone graftEstablishment licence

Produce in the premise that have valid establishment license from

MDA

bone graft

Products that have been/ still certified halal under

Pharmaceutical or Consumer Good Scheme as follow:

a. Bone graftb. Dental Flossc. Dialysis Solutiond. Eye Lubricante. Hemodialysis Solutionf. Humidifier

g. Surgical Meshh.Suturei.Water Injectionj.Wound wash

Subject to the approval of competent authority

Meet other regulation

Meet the requirements of MS 2636, Medical Device Act 2012 (737 Act),

Medical Device Regulations 2012 and other regulations enforce by competent

authority

implantssolution grafting

skin graft, vascular graft, coronary stent heart valve, stent, cochlear implant, IOL.mouth wash, urethral lubricant, personal

Type of products that eligible to halal certified

prosthetic leg, prosthetic knees, prosthetic limb, prosthetic heart valve,

prosthetic ankle joint.

prosthetic

skin graft, vascular graft, coronary stent graft.

heart valve, stent, cochlear implant, IOL.mouth wash, urethral lubricant, personallubricant, disinfecting solution, contact lenssolution, wound irrigation solution, eye solution,saline solution, balance salt solution.

NOT ELIGIBLE

Non halalproducts

Produce & distribute halal-

non halal products

Similar branding halal-non halal

products

Relabeled products

R&D productsNegative impact

on religion & social

NoNoNoNo RequirementsRequirementsRequirementsRequirements NewNewNewNew RenewalRenewalRenewalRenewal Add Add Add Add ProductProductProductProduct

1. Salinan sijil pendaftaran syarikat √

2. Salinan lesen PBT √

3. Salinan penyata kewangan √ √

4. Salinan IC & surat perlantikan pekerja muslim w/negara (tetap)

√ √

—SUPPORTING DOCUMENTS

5. Salinan surat kelulusan MDA √ √ √

6. Permit import dari JPH (jika berkenaan) √

7. Salinan SH ramuan/produk spec. √ √ √

8. Carta alir proses √ √ √

9. Peta lokasi kilang √ √ √

10. Contoh pelabelan √

PERMOHONAN DITOLAK

� Di luar skop pensijilan� Borang permohonan online tidak lengkap� Pengilang bukan pemegang sijil halal� Dokumen sokongan tidak lengkap atau

lambat dihantar� Atas permintaan pemohon.

Application fee

PERMOHONAN PERMOHONAN PERMOHONAN PERMOHONAN KATEGORIKATEGORIKATEGORIKATEGORI FI (RM) FI (RM) FI (RM) FI (RM) TAHUNTAHUNTAHUNTAHUN

PRODUK DAN PERKHIDMATAN PRODUK DAN PERKHIDMATAN PRODUK DAN PERKHIDMATAN PRODUK DAN PERKHIDMATAN INDUSTRIINDUSTRIINDUSTRIINDUSTRI CIRICIRICIRICIRI----CIRICIRICIRICIRI

Mikro Nilai Perolehan tahunan kurang dari RM300,000.00

100

jupiter

Jupiter is the largest planet in our Solar System

Saturn is composed of hydrogen and helium2,500,000

Medical Device

dari RM300,000.00

Kecil Nilai Perolehan tahunan dari RM300,000.00 hingga kurang dari RM14,999,999.99 Juta

400

Sederhana Nilai Perolehan tahunan dari RM15 Juta hingga RM50 Juta

700

Besar Nilai Perolehan tahunan melebihi RM50 Juta

1000

AUDITING PROCEDURE

Site visit (Consist of adequacy & on-site audit)

Response the audit plan

Submit audit plan by email

Follow up audit

Response the NCR report

Issue an audit report

Performed by:

Minimum 2 auditor

refference

The guidelines to be followed in

obtaining Malaysia Halal

Certification.

Comprising application

process, inspection,

monitoring and

enforcement.

SCOPE CERTIFICATION FEEAUDITING

PROCEDURE

DEFINITION

CERTIFICATION

SCHEME

CONDITION FOR

CERTIFICATION

GENERAL

REQUIREMENT

SPECIFIC

REQUIREMENT

APPLICATION

PROCEDURE

MONITORING &

ENFORCEMENT

HALAL

CERTIFICATE &

LOGO

RESPONSIBILITIES

OF CERTIFICATE

HOLDER

CERTIFICATION

PANEL

OTHER REFERENCESOTHER REFERENCESOTHER REFERENCESOTHER REFERENCES

MS 2636MS 2636MS 2636MS 2636

MHMSMHMSMHMSMHMS

LAW & REGSLAW & REGSLAW & REGSLAW & REGSLAW & REGSLAW & REGSLAW & REGSLAW & REGS

FATWAFATWAFATWAFATWA

CIRCULARCIRCULARCIRCULARCIRCULAR

16

Scope of audit

Documentation/ Halal Management System

Raw material & processing aid

Equipment Packaging & labelling StorageDocumentation/

Company profile

Halal Management System

Raw material & processing aid

Equipment Packaging & labelling Storage

Processing Transportation Workers Sanitation system/ cleanliness

Waste disposal management

Premise compound

CRITICAL INGREDIENTS

Plant

• Additive?

• Processing aid?

Chemical

• Organic?

• Processing aid?

Human

• Forbidden!

Microb

• Source of media

• GMO?

• Processing aid?

Animal

• Species of animal

• Slaughter?

• Additive?

• Processing aid?

Recognised cbCountries: 46CBs: 84

Malaysian halal management systemMHMS

SISTEM PENGURUSAN HALAL MALAYSIA

@ MALAYSIA HALAL MANAGEMENT SYSTEM (MHMS)

SISTEM KAWALAN HALAL DALAMAN (IHCS) SISTEM JAMINAN HALAL (HAS)

INDUSTRI KECIL DAN MIKRO INDUSTRI BESAR DAN SEDERHANA

1. Polisi Halal2. Kawalan Bahan Mentah3. Kebolehkesanan

1. Polisi Halal2. Jawatankuasa Halal Dalaman & Eksekutif Halal3. Kawalan Risiko Halal4. Kawalan Bahan Mentah5. Audit Halal Dalaman6. Latihan7. Kebolehkesanan8. Semakan HAS9. Analisis Makmal10. Sertu

Malaysia halal certificate

Register the products with MDA

STAGE 1

Submit your application & documentations

STAGE 3

Understand all the Requirements and be prepared.

STAGE 2

Submit your application & documentations

MS 2636: 2019

Ref/Ruj:1 005-01/2013

Make payment

STAGE 5

Ready with presentation and documetations:• Rekod kawalan makhluk perosak•Rekod maklumat pekerja•Rekod pengeluaran produk•Rekod pembelian/invois

STAGE 6

THANKSDoes anyone have any questions?

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