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Class B — Full Registration

Overview​

Class B devices require a full registration application with a technical dossier and conformity assessment evidence. MDA performs a technical review before issuing the DRN. Target processing time is 90 working days.

Dossier Structure​

Section 1 — Administrative Information​

DocumentNotes
Application formCompleted via MyMDA
Establishment licenceCurrent valid licence
GMDN codeGlobal Medical Device Nomenclature code
Intended purposeDetailed statement of intended use
Device nomenclatureProprietary name and generic name
LAR agreementIf foreign manufacturer
Foreign registration evidenceCE, TGA, FDA, HSA, etc. (if available)

Section 2 — Device Description​

  • Physical description of device including dimensions, materials, components
  • List of variants and configurations covered by the application
  • Accessories included
  • Photographs or technical drawings

Section 3 — Classification​

  • Statement of device class (Class B)
  • Applicable classification rule(s) with justification
  • Explanation if any borderline was considered

Section 4 — Labelling​

  • Proposed device label (all language versions)
  • Instructions for Use (IFU) in English; Bahasa Malaysia version if supplied to general public
  • Compliance with Malaysian labelling requirements (see Labelling Requirements)

Section 5 — Conformity Assessment Evidence​

  • Current ISO 13485 certificate issued by a MDA-recognised certification body
  • Declaration of Conformity to Essential Principles

Section 6 — Technical Documentation Summary​

  • Risk management summary (ISO 14971)
  • Biocompatibility summary (ISO 10993 where applicable)
  • Electrical safety summary (IEC 60601 series if active device)
  • Software lifecycle summary (IEC 62304 if software component)
  • Sterility/sterilisation validation summary (if sterile device)
  • Clinical evaluation summary (literature review or equivalent)
  • Performance testing summary (applicable standards)

Section 7 — Post-Market Information​

  • PMS plan summary
  • Any post-market data (if device is already marketed elsewhere)

Submission and Review Process​

  1. Submit complete dossier via MyMDA
  2. MDA performs administrative acceptance check (~10 working days)
  3. Technical review commences
  4. MDA may issue a Deficiency Letter (DL) requesting clarification or additional data
  5. Applicant responds within stipulated timeframe
  6. MDA completes review and issues DRN or rejection notice

Tips for Class B Applications​

  • Foreign registrations help — include CE certificate, TGA registration, or other approvals as supporting evidence; MDA may place weight on recognised regulator approvals
  • Translate summaries — if source documents are not in English, provide certified translations
  • Ensure ISO 13485 scope matches — the certification scope must cover the device being registered