PBT Factory License

This consists of a premise and signboard permit under a combined composite license from the Local Authority (PBT) where your manufacturing is located.

Specifics depend on the PBT, but general requirements include:

• suitable premises in an industrial / commercial zone
• signboard compliant with PBT signage guidelines
• letters of support from relevant technical agencies
• tenancy / S&P agreement for premises

For details, see our guide to opening a factory in Malaysia.

Customs LMW

Allows manufacturers to import, store, and use raw materials, components, and equipment for manufacturing without immediately paying customs duties.

Eligibility requirements:

• valid MIDA Manufacturing License
• export >80% of total value of finished goods over 12-months
• premises meet Customs security and layout requirements
• separate areas for manufacturing, raw materials, finished goods, and waste

For details, see our guide to LMW applications in Malaysia.

Agency Support Letter

Approvals by technical agencies confirming your manufacturing premises meets safety, environmental, or occupational health requirements.

The three most common agencies are:

• Fire and Rescue Department (BOMBA)
• Department of Environment (DOE)
• Department of Occupational Safety and Health (DOSH)

Exact agencies depend on your business, but they are a prerequisite for PBT composite licenses. For details, see our guide to BOMBA support letter applications.

MIDA Expat Visa

MIDA reviews visa applications for foreign investors and skilled professionals in Malaysia’s manufacturing sector, and based on role and purpose the three most common are:

• MIDA Investor Pass for foreign investors visiting Malaysia to oversee existing operations, negotiate planned investments, or explore investment opportunities
• MIDA Employment Pass (EP) for expatriates employed full-time by Malaysian manufacturers
• MIDA Professional Visit Pass (PVP) for expatriates providing short-term services or training in Malaysia on behalf of their foreign employer

Each route has different eligibility requirements and for details, see our guide to MIDA Investor or MIDA Employment Passes .

Halal OEM Certificate

Grants manufacturers Halal certification for their manufacturing services so they can produce products on behalf of another company.

General requirements:

• premises operational for at least three months
• valid PBT premise license
• premises only manufacture / handle Halal products
• written manufacturing agreement between the OEM and brand owner, and
• appropriate internal Halal management system based on operation size

Depending on the type of manufacturing, additional licenses may be needed, and for details, see our guide to Halal OEM manufacturing in Malaysia.

GMP Inspection Advisory

For products regulated by the National Pharmaceutical Regulatory Agency (NPRA), GMP compliance is required to ensure products are consistently manufactured to meet quality, safety, and efficacy requirements.

Manufacturers must pass an NPRA inspection covering:

• manufacturing and storage facilities
• quality control laboratories
• documentation and quality systems
• production processes, and
• overall compliance with GMP guidelines

For details, see NPRA’s official guidance on preparing for GMP inspections.

MOH MeSTI / HACC

For food manufacturers in Malaysia MeSTI and HACCP are two important food safety schemes enforced by the Ministry of Health (MOH).

General requirements include:

• valid food premises and business registrations
• food safety management procedures appropriate to the operation
• clean and suitable manufacturing premises
• proper hygiene, pest control, storage, and sanitation procedures
• trained food handlers and relevant personnel
• appropriate documentation and record-keeping, and
• ongoing monitoring and corrective actions to maintain food safety
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MeSTI is the more basic food safety assurance system for smaller food manufacturers, while HACCP is more comprehensive and designed for larger operations. For details, see the MOH MeSTI and HACCP guidelines.

Various ISOs

• ISO 9001 – Quality Management System (QMS)
• ISO 14001 – Environmental Management System (EMS)
• ISO 45001 – Occupational Health & Safety Management System (OH&S)
• ISO 37001 – Anti-Bribery Management System (ABMS)
• ISO 22000 – Food Safety Management System (FSMS)
• ISO 13485 – Medical Devices Quality Management System (MDQMS)
• ISO 27001 – Information Security Management System (ISMS)
• ISO 50001 – Energy Management System (EnMS)
• ISO 22301 – Business Continuity Management System (BCMS)
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