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Malaysia medical device government fees

Row-level verified

MDA current fee schedule, reviewed for 2026, in MYR.

22 fee lines100% exact amountscurrency MYRFX rates 2026-11-09reviewed 2026-08-25
Fee lineOfficial amountUSD equivalentFrequencyProvenance
Registration application fee - Class AMYR 500$123Per applicationVerified
Registration application fee - Class BMYR 250$61.59Per applicationVerified
Registration application fee - Class CMYR 500$123Per applicationVerified
Registration application fee - Class DMYR 750$185Per applicationVerified
Registration fee (on registration) - Class AMYR 750$185Per registration, 5-year validityVerified
Registration fee - Class BMYR 1,000$246Per registration, 5-year validityVerified
Registration fee - Class CMYR 2,000$493Per registration, 5-year validityVerified
Registration fee - Class DMYR 3,000$739Per registration, 5-year validityVerified
Registration fee - device incorporating a medicinal productMYR 5,000$1,232Per registration, 5-year validityVerified
Establishment-licence application fee (per role: manufacturer, AR, distributor, importer)MYR 250$61.59Per roleVerified
Establishment licence - manufacturerMYR 4,000$986Per licenceVerified
Establishment licence - authorised representativeMYR 4,000$986Per licenceVerified
Establishment licence - distributorMYR 2,000$493Per licenceVerified
Establishment licence - importerMYR 2,000$493Per licenceVerified
Establishment-licence renewal application feeMYR 200$49.28Per roleVerified
Establishment-licence renewal - manufacturer or authorised representativeMYR 2,000$493Per renewalVerified
Establishment-licence renewal - distributor or importerMYR 1,000$246Per renewalVerified
Conformity-assessment-body registration applicationMYR 1,500$370Per applicationVerified
Conformity-assessment-body registrationMYR 8,000$1,971Per registrationVerified
Export permitMYR 100$24.64Per permitVerified
AppealMYR 250$61.59Per appealVerified
Advertising-approval processing fee
Medical Device (Advertising) Regulations 2019 reg. 2(3)(b).
MYR 1,000$246Per advertisementVerified
Government fees only β€” service and testing costs are separate
  • Fees follow the Medical Device Regulations 2012 Fifth Schedule as amended by P.U.(A) 330/2025 from 1 January 2026: Class A application rose from RM100 to RM500 and a Class A registration fee of RM750 was introduced.
  • Application and registration fees are cumulative per device; establishment licences are billed per role.
  • Conformity-assessment-body charges are separate commercial fees.
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Exact amounts verified against the MDA fee schedule Β· full review 2026-08-25 Β· row IDs are stable β€” cite as government-fees:malaysia:application-fee-class-a