Manufacture of medical diagnostic preparation
This activity involves the production of medical diagnostic preparations used for identifying diseases or conditions in patients. It includes the manufacture of various diagnostic tests, such as pregnancy tests, that are utilized in medical settings to aid in diagnosis.
Manufacturing companies with shareholders' funds >= RM2.5M OR >= 75 full-time paid employees require a Manufacturing Licence from MIDA. 100% foreign equity is permitted.
- Foreign equity
- 100%
- Capital floor
- RM 2.5M
- Key licences
- 3
- Setup timeline
- 8–12 wk
Foreign ownership rules
Foreign ownership rules
- Manufacturing Licence (ICA 1975)open-with-licenseMIDA
Manufacturing companies with shareholders' funds >= RM2.5M OR >= 75 full-time paid employees require a Manufacturing Licence from MIDA. 100% foreign equity is permitted.
Paid-up min: RM2,500,000Source
Sourced from MIDA sector booklets and respective regulators. Verify the latest rules with the regulator before investment decisions.
Licences & permits
Licences & permits
- Import of Test Kit Containing Dangerous Drugs or Psychotropic Substances AuthorizationIssued by Ministry of Health · Poison Regulations (Psychotropic Substances) 1989; Dangerous Drugs Act 1952Auto-mapped via semantic similarity (0.43)Fee: RM 100 processing + RM 0 annualValidity: 1 year or until December 31 of the current year
- Manufacturing Licence (MIDA, ICA 1975)Issued by Malaysian Investment Development Authority (MIDA) · Industrial Co-ordination Act 1975Required if shareholders' funds >= RM2.5M OR >= 75 full-time employees
Common requirements for most Malaysian businesses6
- Sales & Service Tax (SST) RegistrationIssued by Royal Malaysian Customs Department (RMCD)
- Signboard / Advertisement Licence (PBT)Issued by Local Authority (PBT)
- Bomba Fire Safety Certificate (Sijil Perakuan Bomba)Issued by Fire and Rescue Department of Malaysia (Bomba)
- EPF / SOCSO / EIS Employer RegistrationIssued by KWSP (EPF), PERKESO (SOCSO), EIS
- Local Authority Business LicenceIssued by Local Authority (PBT)
- LHDN Employer Tax (E) RegistrationIssued by Inland Revenue Board of Malaysia (LHDN/HASiL)
Have Emerhub file every licence above for you
We'll prepare the forms, liaise with each agency and track approvals — bundled with Sdn Bhd setup. Agency fees are paid to the issuing authority; our service fee is quoted separately.
Get a quoteSource: MalaysiaBiz / BLESS licence catalog.
Activity details
pregnancy test
SST & Withholding Tax
Risk Level
Capital Allowance: Eligible for Heavy Machinery rate (20% Initial Allowance / 20% Annual Allowance).
Government Grants
Eligible for SME Corp manufacturing grants and industry development programmes.
e-Invoicing (MyInvois)
MSIC code 21005 is required when issuing e-invoices via LHDN MyInvois. Use this code in the Classification field of your e-invoice.