Services Provided
System Account Registration
- FOSIM System Account Registration
Product Registration
- Providing Food Product Registration
Complete Guide to Malaysia FOSIM (Food Safety Information System) Registration
Prepackaged Foods/Processed Foods/Imported Food Essential for Market Access in Malaysia
1. Understanding FOSIM Registration
FOSIM (Food Safety Information System Malaysia) is the Food Safety Information System of Malaysia, under the Malaysia Food and Drug Authority (MDA), and it is the market access system for food products in MalaysiaMandatory registration systemAll pre-packaged foods and processed foods sold or imported in Malaysia must complete FOSIM registration. Unregistered products are prohibited from customs clearance and shelf sales. Registration information is synchronized in real-time with the Malaysian customs and supermarket supervision systems, serving as the core access credential for foods entering the Malaysian market.
1.1 Which products require FOSIM registration?
| Category | Specific product |
|---|---|
| Prepackaged food | Snacks, seasonings, canned food, convenience food, baked goods, dairy products |
| Processed food | Frozen prepared foods, cooked meats, pickled foods, dehydrated foods, puffed foods |
| Beverages | Bottled water, fruit juice, tea beverages, carbonated drinks, functional drinks (non-alcoholic) |
| Special dietary food | Infant formula foods, meal replacement foods, sports nutrition foods, elderly dietary foods |
| Imported food | All foods imported from abroad for sale in Malaysia (including bulk foods that are repackaged after import) |
- Fresh unprocessed agricultural products (such as fresh fruits and vegetables, raw meat) only need to complete FOSIM filing and do not require formal registration
- Food intended only for export transit (not entering the Malaysian domestic market) can apply for registration exemption (requires customs certification)
1.2 FOSIM Registration Types
| Registration Type | Applicable Products/Scenarios | Validity period |
|---|---|---|
| Product Registration | Prepackaged food, processed food, beverages (core registration types) | 3 years (renewal required 3 months in advance) |
| Importer Registration | All Malaysian local importers of imported food | 2 years (annual information update) |
| Manufacturer Registration | Malaysian Local Food Manufacturers / Overseas Food Manufacturers (Exporting to Malaysia) | 3 years (GMP review required for renewal) |
| Temporary Registration | For food displayed at exhibitions, trial sales, short-term promotions (not for long-term sales) | 6 months (non-renewable) |
| Notification | Fresh agricultural products, bulk foods (non-prepackaged) | Permanently valid (annual verification required) |
II. Registration Process & Core Required Documents
Document Preparation and Pre-assessment
Preparation StageConfirm product classification (prepackaged/processed/special dietary), organize food safety documents and ingredient lists, complete qualification verification of Malaysian local importer/agent (FOSIM registration requires a local entity).
FOSIM System Account Activation
3-5 working daysMalaysian local registration entity (importer/manufacturer) applies to MDA for a FOSIM system account, submits company qualification documents to complete account verification and activation.
Online Submission of Registration Documents
5-10 working daysUpload product documents, safety reports, label samples, etc., through the official FOSIM system, and pay registration fees (charged by product category).
Document Review and Supplementation
15-30 working daysThe MDA review team checks the completeness and food safety of documents. If additional documents are needed, a supplementation notice will be issued (up to 2 chances for supplementation).
Approval of Registration and Issuance of Registration Number
5-7 working daysAfter approval, the FOSIM system generates a unique registration number, and product information is entered into the Malaysian Food Safety Database, allowing official customs clearance and sales.
Core Required Documents for Registration
Applicant Information
- SSM Registration Certificate (Business License) of Malaysian local importer/manufacturer
- Tax Registration Certificate (LHDN) and Food Business License
- Power of Attorney (POA, notarized for overseas companies)
- Company Compliance Declaration (no food safety violations)
Basic Product Information
- Full Ingredient List of the Product (Malay, English, in descending order of content)
- Product Specifications, Packaging Design Drafts, Label Samples (including Malay)
- Product Manual (Malay, English, without exaggerated claims)
- Product Manufacturing Process Flowchart (including key control points)
Food Safety Information
- Manufacturer's GMP/HACCP Certification (MDA Recognized)
- Product Microbiological Test Report (Total Colony Count, Pathogenic Bacteria)
- Heavy Metal/Additive Test Report (Compliant with Malaysian Food Standards)
- Shelf Life Stability Test Report (at least 12 months)
Special Product Registration Materials (classified by product category)
Pre-packaged Food Registration Materials
- Allergen Labeling Description (e.g., nuts, dairy, gluten, etc.)
- Food Additive Compliance Certification (Compliant with Malaysian Food Act 1983)
- Nutrition Facts Label (Malay, English, indicating energy/protein, etc.)
- Packaging Material Safety Test Report (Food Contact Compliance)
- Batch Release Inspection Report (within the past 6 months)
- Non-irradiation/Non-GMO Statement (if applicable)
- Raw Material Traceability Certificate (key ingredients such as meat/dairy)
Frozen Food Registration Materials
- Cold Chain Transportation Verification Report (temperature control 0-4℃)
- Post-thaw Microbiological Stability Test Report
- Frozen Processing Verification Report (No quality deterioration)
- Packaging Low Temperature Resistance Test Report
- Halal Slaughter Certificate for Meat Products (if applicable)
- Declaration of No Refreezing After Thawing
- Storage Condition Compliance Certificate (Local Malaysian Cold Storage)
Special Dietary Food Registration Materials
- Formulation Nutrient Ratio Verification Report (Compliant with Malaysian Dietary Standards)
- Clinical Nutrition Assessment Report (Mandatory for Infant/Elderly Foods)
- Proof of no banned additives (such as hormones, stimulants)
- Production Environment Cleanliness Test Report (Class 100000)
- Malay nutrition claims (no exaggerated medical efficacy)
- Special raw material compliance certificates (such as organic certification)
- Adverse reaction monitoring program (infant food)
3. FOSIM registration tag requirements
General requirements
- It must be annotatedMalay EnglishBilingual, Malay font size ≥ 12 and no smaller than English
- Clearly display the FOSIM registration number (format: FOSIM/XXX/YYYY/ZZZZ)
- Indicate the manufacturer/importer's name, address, and local Malaysian contact information
- Production date, expiration date (DD/MM/YYYY), batch number, and storage conditions
- Complete Nutrition Facts (core indicators such as energy, protein, fat)
Special restrictions
- Ordinary foods: Medical claims such as "health care" or "treatment" are prohibited; only nutritional benefits may be labeled
- Special diets: Must indicate "special dietary foods" and suitable groups (e.g., "for infants and young children").
- Imported food: Must affix a Malay traceability label indicating the country of origin and importer information
- Allergens: Must be prominently marked (e.g., "contains nuts" or "may contain gluten"), font ≥ size 10
Format and violation explanations
-
Format standardized
The FOSIM registration number must be printed prominently on the front of the packaging (not foldable/obstructed), and the label must be waterproof and wear-resistant; The nutrition facts table must use the MDA-specified format; Imported foods must be marked with "Imported by: [Importer Name]" and the corresponding Malay translation
-
Violation penalties
Missing or incorrect labels: maximum fine of 300,000 ringgit (about 470,000 RMB), forced removal and recall of products; Misuse of FOSIM registration number: up to 2 years imprisonment and permanent listing on MDA blacklist; Unregistered sales of food: confiscation of all inventory, fines three times the value of goods, and subsequent food imports prohibited
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