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MDA · Act 737 ss.10–14 · MDA/GD/0068 · Circular 2/2025

Conformity Assessment Bodies (CABs) in Malaysia.

Every Class B, C and D device passes through a CAB before MDA will register it. Which route the CAB takes, full assessment or verification of a foreign approval, decides most of your cost and timeline. Here is how CABs fit into MDA registration, and who is on MDA’s register today.

HSA verification route
01 MDA Registration02 GDPMD + Licensing03 ISO 13485 QMS04 MDSAP05 CE / FDA Export
The law

What a CAB is and does.

  • Act 737 section 7: MDA registers a device only after conformity assessment by a CAB. Class A is exempt (Exemption Order 2024, paragraph 5).
  • Sections 10–14: only a CAB registered with MDA may carry out conformity assessment. It must be independent of the device, the establishment and related companies, keep information confidential, and its person in charge must be a Malaysian citizen. MDA can audit, suspend or cancel it.
  • Medical Device Regulations 2012: the procedure is in the Third Schedule and CAB requirements in the Fourth Schedule. A CAB is registered for 3 years.

What the CAB assesses

Under the Third Schedule, conformity assessment covers four elements:

  1. The manufacturer’s quality management system.
  2. The post-market surveillance system.
  3. Technical documentation, summarised in the CSDT format.
  4. The Declaration of Conformity.

For Class B the CAB may review and audit on site; for Classes C and D it must, and it also reviews the technical documentation summary.

Full conformity assessment vs verification

VerificationFull conformity assessment
WhenAt least one recognised foreign approval, same design and intended purpose, no global safety issues in the last year, never rejected or withdrawnNo recognised approval, or the foreign approval was cancelled
CAB effortAbout 4 hours of review per device application; about 1.5 months overallFull review of QMS, PMS, CSDT and DoC
GuidanceMDA/GD/0068 (CAB), MDA/GD/0070 (applicant), 2nd editions 2025MDA/GD/0031
Certificate5 years; recertification at re-registrationIssued by the CAB

Recognised regulators for verification

Under Circular 2/2025 (effective 30 September 2025) and MDA/GD/0068 Appendix 1:

  • EU notified bodies (MDD, MDR, IVDD, IVDR)
  • US FDA (510(k) or PMA)
  • Health Canada (device licence)
  • Australia TGA (ARTG entry)
  • Japan MHLW (Shonin, or Ninsho from a registered certification body)
  • UK MHRA (UKCA, CE or UKNI)
  • Singapore HSA (SMDR listing), added 2025
  • Thai FDA, added 2025

Emergency and special-access approvals (FDA EUA or HDE, Health Canada SAP, TGA SAS, HSA special access) do not count. Details of the Singapore route: HSA verification route.

MDA’s registered CABs

MDA’s list, revised 24 September 2026, has 25 CABs, all registered for verification:

TÜV SÜDSGSSIRIM QAS InternationalBSI Services MalaysiaDQS
TÜV RheinlandTÜV NORDCare Certification InternationalCI International CertificationKGS
DNV GL InternationalGenuine DiamondASIMediviceKiwa International
AQC Technical AssessorsNIOSH CertificationPlatinum Shauffmantz VeritasLeaderIntertek Certification International
StraitAmdextPrecision Management CertificationARG InternationalIntercontinental

CABs do leave the register. Medcert Malaysia stopped operating in August 2025 and its registration was not renewed after 20 November 2025; its certificates stay recognised until they expire. Check MDA’s list before choosing a CAB, and again before re-registration.

CAB fees

CAB fees are commercial; MDA sets no schedule for what a CAB charges. Our all-in registration fees include the CAB fee and MDA’s fees: RM6,800 (Class B), RM9,800 (Class C) and RM12,000 (Class D) per device. Full breakdown: registration cost.

Jawapan ringkas · Bahasa Malaysia

Apakah Badan Penilaian Pematuhan (CAB) dalam pendaftaran MDA?

CAB ialah badan yang berdaftar dengan MDA di bawah seksyen 10–12 Akta 737 untuk menilai pematuhan peranti perubatan Kelas B, C dan D sebelum pendaftaran. Peranti Kelas A dikecualikan (Perintah Pengecualian 2024). Senarai MDA (24 September 2026) mengandungi 25 CAB. Laluan verifikasi digunakan jika peranti telah diluluskan oleh pengawal selia yang diiktiraf, termasuk HSA Singapura dan FDA Thailand. WhatsApp 010-206 2070.

FAQ

Frequently asked questions

What is a Conformity Assessment Body (CAB)?
A body registered with MDA under sections 10–12 of the Medical Device Act 2012 (Act 737) to assess whether a medical device conforms to the essential principles of safety and performance. MDA registers a Class B, C or D device only after it has been through conformity assessment by a CAB (section 7). A CAB must be independent of the device and the establishment, and its person in charge must be a Malaysian citizen.
How many CABs are registered with MDA?
Twenty-five, on MDA’s list revised 24 September 2026, including TÜV SÜD, SGS, SIRIM QAS International, BSI Services Malaysia, TÜV Rheinland, TÜV NORD, DNV and Intertek. Each CAB is registered for 3 years (regulation 9(3)). MDA publishes the list on its Conformity Assessment Body page; check it before you sign, because CABs do leave the register.
Does a Class A device need a CAB?
No. Paragraph 5 of the Medical Device (Exemption) Order 2024 (P.U. (A) 78) exempts Class A devices from conformity assessment by a CAB. Class A applications go straight to MDA through MeDC@St.
What is the difference between full conformity assessment and verification?
Verification applies when the device already has at least one approval from a recognised regulator, the same design and intended purpose, no global safety issues in the past year and no rejection or withdrawal anywhere; the CAB verifies that approval instead of assessing from scratch. Full conformity assessment applies when there is no recognised approval. MDA/GD/0068 (2nd Edition, September 2025) sets the conditions.
Which foreign approvals qualify for the verification route?
Approvals from EU notified bodies (MDD/MDR/IVDD/IVDR), Japan (MHLW Shonin or Ninsho), Australia’s TGA (ARTG), Health Canada (licence), US FDA (510(k) or PMA), UK MHRA, Singapore HSA (SMDR listing) and Thai FDA. HSA and Thai FDA were added under Circular 2/2025, effective 30 September 2025. Emergency and special-access approvals such as FDA EUA or HDE do not qualify.
How much does a CAB charge?
CAB fees are commercial; no MDA schedule sets what a CAB charges an applicant. The only CAB fees in law are those a CAB pays MDA to be registered. Our all-in registration fees include the CAB fee: RM6,800 (Class B), RM9,800 (Class C) and RM12,000 (Class D) per device.
How long is a CAB certificate valid?
A CAB certificate of conformity on the verification route is valid 5 years, matching the 5-year device registration. At re-registration the CAB performs a recertification assessment, which needs a valid registration certificate. If the foreign approval relied on is cancelled, a full assessment is required.

Not sure which CAB route applies?

Send us the device’s foreign approvals and class. We will confirm whether verification applies, choose the CAB and include its fee in one all-in price.

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