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Evaluation Routes

Overview​

The evaluation route determines how HSA reviews a Class B, C, or D registration application — how much documentation is required, how long the review takes, and what fees apply. There are four routes:

RouteConditionsAvailable for
FullNo prior approval from any overseas reference agencyClass B, C, D
AbridgedApproval from ≥1 overseas reference agencyClass B, C, D
Expedited — ECR≥1 reference agency approval + ≥3 years safe marketing, or ≥2 approvalsClass C only
Expedited — EDR≥2 reference agency approvals + no prior rejection/withdrawalClass D only
Immediate — IBRSpecific conditions (see below)Class B only; also SaMD Class B & C

Full evaluation​

The Full evaluation route applies where the device has no prior approval from any of HSA's recognised overseas reference agencies.

HSA conducts a complete independent evaluation of all technical content, including clinical evidence, design and manufacturing documentation, and risk management. Full evaluation has the longest turnaround time and highest documentation requirements of all routes.

The Priority Review Scheme is available for Full evaluation route submissions — it provides a faster TAT for devices that address unmet clinical needs or provide significant health benefits. See Priority Review Scheme.

Abridged evaluation​

The Abridged evaluation route applies where the device has approval from at least one of HSA's five recognised overseas reference agencies:

  1. Australia Therapeutic Goods Administration (TGA) — Device Registration Licence
  2. European Union Notified Bodies (EU NB) — EC certificates under MDD, MDR, IVDD, or IVDR (specific certificate types required — see table below)
  3. Health Canada (HC) — Device Licence
  4. Japan Ministry of Health, Labour and Welfare (MHLW) — Ninsho (certification) or Shonin (approval)
  5. US Food and Drug Administration (FDA) — 510(k) clearance, De Novo, or PMA

Under abridged evaluation, HSA gives significant weight to the reference agency's assessment but still conducts its own review. Documentation requirements are reduced compared to Full evaluation.

Important caveat: Class I (or Class I/II exempt) approvals from reference agencies do not qualify a device for abridged or expedited routes. The overseas approval must correspond to a Class B, C, or D device in Singapore.

EU NB certificate types recognised by HSA​

For Class B abridged route (Class IIa equivalent):

  • MDD Annex II section 3 or Annex V
  • MDR Annex IX Chapter I and III, or Annex XI Part A
  • IVDD Annex IV or V with VII (List B and self-testing)
  • IVDR Annex IX Chapter I and III

For Class C and D abridged route (Class IIb/III equivalent):

  • MDD Annex II section 3 or III with V (Class IIb), or Annex II sections 3 and 4 (Class III)
  • MDR Annex IX (with technical documentation assessment for implantables), or Annex X with XI Part A
  • Directive 90/385/EEC Annex II sections 3 and 4 (Active Implantable Devices)
  • IVDD Annex IV including sections 4 and 6 (List A)
  • IVDR Annex IX with technical documentation (Class D IVD), or Annex X with XI (Class C IVD)

Expedited routes​

Expedited Class C Registration (ECR)​

The ECR route provides a faster evaluation path for Class C devices. There are two ECR conditions:

ECR-1:

  • Approval from ≥1 overseas reference agency; and
  • Marketed for ≥3 years in that jurisdiction; and
  • No known safety issues globally; and
  • No prior rejection or withdrawal by HSA or any reference agency.

ECR-2:

  • Approval from ≥2 overseas reference agencies; and
  • No prior rejection or withdrawal by HSA or any reference agency.

ECR exclusions — the following Class C devices cannot use ECR and must use Full or Abridged:

  • Hip, knee, and shoulder joint replacement non-bioactive implants

Expedited Class D Registration (EDR)​

The EDR route applies for Class D devices where:

  • Approval from ≥2 overseas reference agencies; and
  • No prior rejection or withdrawal by HSA or any reference agency.

EDR exclusions — the following Class D devices cannot use EDR:

  • Active implantable devices (pacemakers, neurostimulators)
  • Implantable devices contacting the central circulatory system or CNS
  • Hip, knee, and shoulder joint replacements (bioactive implants)
  • Devices with a registrable drug in a secondary role
  • IVD assays for HIV testing and blood/tissue donor compatibility testing

Immediate routes​

Immediate Class B Registration (IBR)​

IBR is the fastest route available. Two conditions:

IBR Condition 1:

  • Approval from ≥1 overseas reference agency; and
  • Marketed for ≥3 years in that jurisdiction; and
  • No known safety issues globally; and
  • No prior rejection or withdrawal by HSA or any reference agency.

IBR Condition 2:

  • Approval from ≥2 overseas reference agencies; and
  • No known safety issues globally; and
  • No prior rejection or withdrawal by HSA or any reference agency.

Immediate route for standalone SaMD​

There is a dedicated immediate route for standalone medical mobile applications (Class B and Class C), requiring:

  • Approval from ≥1 overseas reference agency; and
  • No known safety issues globally; and
  • No prior rejection or withdrawal by HSA or any reference agency.

Checking your route​

HSA provides an interactive tool to check registration and licensing requirements based on device class, overseas approvals, and marketing history:

hsa.gov.sg/medical-devices/registration/requirements

Official sources​