Class B — Low-Medium Risk
Definition and Scope
Class B devices present a low to medium risk and require a full registration dossier with conformity assessment evidence. They are typically invasive short-term devices or non-invasive devices that interact with the body in more significant ways than Class A.
Classification Criteria
A device is typically Class B when it:
- Is invasive through body orifices or through the skin surface for short-term use
- Is intended for channelling or storing blood, body fluids, or tissue
- Is a non-active implantable device for short-term use (< 30 days)
- Supplies energy to the body but is not life-sustaining
- Measures physiological parameters where errors may cause harm
Class B Examples
| Product | Notes |
|---|---|
| Hypodermic needles and syringes | Invasive, short-term |
| Urinary catheters | Invasive through orifice |
| Wound drainage systems | Contact with body fluids |
| Blood pressure monitors (non-invasive) | Measures physiological parameters |
| Oxygen masks | Short-term orifice invasive |
| Surgical gloves (sterile) | Sterile, invasive-adjacent use |
| Dental fillings and temporary implants | Short-term implantable |
| Glucose meters | In vitro diagnostic, Class B IVD |
| Hearing aids | Partially invasive, energy-supplying |
| Ophthalmic viscosurgical devices | Short-term invasive |
Registration: Full Dossier
Class B devices require a full registration application via MyMDA with the following core components:
Administrative Section
- Application form
- Establishment licence details
- Device nomenclature and GMDN code
- Intended purpose statement
Technical Section
- Device description and specifications
- Classification justification
- List of applicable standards
- Risk management summary (ISO 14971)
- Biocompatibility summary (ISO 10993 where applicable)
- Electrical safety summary (IEC 60601 series where applicable)
- Software documentation (if applicable)
- Sterility and sterilisation validation (if applicable)
Conformity Assessment Evidence
- ISO 13485 QMS certificate from a recognised certification body
- Declaration of Conformity to Essential Principles
Labelling Section
- Proposed label and Instructions for Use (IFU)
Processing Timeline
Target: 90 working days from acceptance of complete application.
Deficiency Letters
If MDA raises queries (Deficiency Letter), the clock pauses. Respond within 30–60 days to avoid rejection.