Food Regulatory Authority of Malaysia

The Food Safety and Quality Division (FSQD) under the Ministry of Health Malaysia is responsible for the planning, supervision and enforcement of food safety, hygiene and quality in accordance with relevant legislative provisions.

Official Website of the Regulatory Division: http://fsq.moh.gov.my

Applicable Regulations

• Food Act 1983
• Food Regulations 1985

Food Risk Classification

Malaysia implements a risk-based food classification system. Documentation requirements and customs inspection protocols differ in accordance with each product’s assigned risk tier.

Prerequisites for Market Access

• Letter of Authorization
• Complete importer particulars and full product information
• Full ingredient list together with official food-drug classification outcome and compliant product labels
• Official label review or consultation document
• Supporting certificates for any quality claims stated on labels (e.g., GMP, HACCP)
• Additional supporting materials subject to regulatory review as required

Accepted Filing Languages

English or Bahasa Malaysia. Translations in other languages must be officially certified or authenticated.

Required Documentation for Filing

1.Enterprise Qualification DocumentsBusiness registration certificate and SSM (Suruhanjaya Syarikat Malaysia) Memorandum and Articles of Association. For importers, supporting documents of business premises such as tenancy agreements or local authority premises licences are mandatory.2.Letter of AuthorizationAuthorization document issued by the manufacturer to the local importer.3.Product Technical DossiersFull ingredient list with INS numbers specified for all food additives, complete product specification sheet and manufacturing process flow chart.4.Label and Packaging MaterialsClear draft artwork of pre-packaged food labels fully complying with Malaysian labelling laws. Labels must be presented in English or Bahasa Malaysia; certified translations are required for any other languages used.5.Test and Certification DocumentsOfficial health certificate or Certificate of Free Sale issued by the country of origin, full product test reports, and quality system certifications including GMP, HACCP and MeSTI as applicable.

Filing Procedures, Review Timeline and Administrative Fees

Standard Filing WorkflowStep 1: Official product risk classification 

Step 2: Regulatory label review 

Step 3: Customs import clearance formalities

2.Supplementary Notes

Two rounds of supplementary revision are allowed for food label submissions. Applications will require resubmission if labels still fail compliance assessment after two revisions.All other import formalities shall follow the prevailing customs regulatory requirements of Malaysia.