November 2017

MEDICAL DEVICE GUIDANCE

GN-12-1: Guidance on Grouping of Medical Devices

for Product Registration
– General Grouping Criteria

Revision 2.1
MEDICAL DEVICE GUIDANCE NOVEMBER 2017

CONTENTS
PREFACE ........................................................................................................... 3
1. INTRODUCTION .......................................................................................... 5
1.1. Purpose ..................................................................................................... 5
1.2. Background................................................................................................ 5
1.3. Scope ........................................................................................................ 6
1.4. Definition.................................................................................................... 6
2. GENERAL PRINCIPLES OF GROUPING .................................................. 8
3. GROUPING CATEGORIES ....................................................................... 10
3.1. FAMILY.................................................................................................... 10
Decision Flowchart for Grouping of Medical Devices as a FAMILY ........ 15
3.2. SYSTEM .................................................................................................. 18
Decision Flowchart for Grouping of Medical Devices as a SYSTEM ...... 19
3.3. IVD TEST KIT .......................................................................................... 22
Decision Flowchart for Grouping of Medical Devices as an IVD TEST KIT
................................................................................................................... 23
3.4. IVD CLUSTER ......................................................................................... 25
Decision Flowchart for Grouping of Medical Devices as an IVD CLUSTER
................................................................................................................... 36
3.5. GROUP ................................................................................................... 39
Decision Flowchart for Grouping of Medical Devices as a GROUP ........ 42
3.6. SINGLE ................................................................................................... 43

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PREFACE

R1.1 ►This document is intended to provide general guidance. Although we

have tried to ensure that the information contained here is accurate, we do not,
however, warrant its accuracy or completeness. The Health Sciences Authority
(HSA) accepts no liability for any errors or omissions in this document, or for
any action/decision taken or not taken as a result of using this document. The
information contained in this document should not be a substitute for
professional advice from your own professional and healthcare advisors. ◄

R2 ►Update Process for this Guidance Document

This version of GN-12 guidance document applies to all medical device
registration applications submitted to HSA. The grouping criteria described in
the GN-12-1 and GN-12-2 shall be strictly adhered to in submitting your medical
devices for registration.

Any requests to reconsider or review these existing grouping criteria shall be

submitted via email to [email protected] with subject header “Request
for review of GN-12 grouping criteria”. The email should include detailed
information regarding:
(i) Device type and description
(ii) Existing grouping options and their limitations (if any)
(iii) Proposed grouping criteria and the rationale
(iv) Technical/scientific information to support the above proposal

Such requests received will be reviewed by HSA periodically and if deemed

acceptable, the GN-12-1 and GN-12-2 guidance documents will be updated.
Updating of the documents will only be done bi-annually (once in 6 months)
depending on the number of requests received in the period. Any new or revised
grouping criteria shall be implemented only after these have been published
online as revised versions of the GN-12-1 and GN-12-2 guidance documents.
◄

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MEDICAL DEVICE GUIDANCE NOVEMBER 2017

REVISION HISTORY

Guidance Version (Publish Date) Revision

GN-12: Revision 1 (January 2011) R1
R1.1 ►GN-12: Revision 1.1 (May 2014) R1.1
R2 ► GN-12-1: Revision 2 (21 June 2016) R2
R2.1 ►GN-12-1: Revision 2.1 (01 November 2017) R2.1

*Where applicable, changes and updates made in each document revision are
annotated with or within the arrow symbol “►”. Deletions may not be shown

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MEDICAL DEVICE GUIDANCE NOVEMBER 2017

1. INTRODUCTION

R2 ►
1.1. Purpose

This document is meant to provide general guidance in determining whether

certain medical devices can be included together and submitted in one product
registration application. Grouping of medical devices for product registration
facilitates the inclusion of multiple devices in one application.

1.2. Background

Under the Health Products Act (Act), all medical devices to be supplied locally
are required to be registered with HSA prior to supply unless an exception from
the registration requirement has been provided for in the regulations.

Medical devices range from simple medical devices (e.g. syringe) to highly
complex medical devices (e.g. implantable pacemakers) including devices that
comprise of myriad components (e.g. patient monitoring systems). These
various components or modules can be sold individually, in different
combinations as required by the end user, as a convenient all-in-one kit, or as
an individually customised pack. Individual medical devices are also typically
available in various configurations including length, diameter, etc. There are
also certain device specific attributes, such as those specific to in vitro
diagnostic devices and hearing aids, which should be considered when
categorising devices for the purpose of grouping.

To better cater for the diverse categories of medical devices, grouping criteria
that applies generally to medical devices and also device specific grouping
categories have been developed and are presented in this GN-12-1 and the
GN-12-2 guidance documents, respectively. Applicants should determine and
perform the grouping of medical devices to be registered based on GN-12-1
and GN-12-2 guidance documents when preparing their medical device product
registration submissions. ◄

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1.3. Scope

This document applies to all medical devices.

1.4. Definition

Definitions, which are not set out in the Act and Health Products (Medical
Devices) Regulations (Regulations), are intended as guidance in this
document. These definitions are not taken verbatim from the above legislation
and should not be used in any legal context. These definitions are meant to
provide guidance in layman terms.

R2 ►
ACCESSORY: for the purposes of this guidance document, means an article
that is intended specifically by its product owner to be used together with a
particular medical device to enable or assist that device to be used in
accordance with its intended purpose. An accessory is typically intended to be
used for one or more of the purposes as described in the definition of medical
device and therefore should be considered a medical device. COMPONENT

PROPRIETARY NAME: for the purposes of this guidance document, a unique

name given by the product owner to identify a medical device as a whole
product, also known as the trade name or brand name.

INTENDED PURPOSE/INTENDED USE (as set out in the Regulations): in

relation to a medical device or its process or service, means the objective
intended use or purpose, as reflected in the specifications, instructions and
information provided by the product owner of the medical device. ◄

MEDICAL DEVICE: means a medical device as described in the First Schedule

of the Act.

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R2 ►
PRODUCT OWNER (as set out in the Regulations): in relation to a health
product, means a person who —
(a) supplies the health product under his own name, or under any trade mark,
design, trade name or other name or mark owned or controlled by him; and
(b) is responsible for designing, manufacturing, assembling, processing,
labelling, packaging, refurbishing or modifying the health product, or for
assigning to it a purpose, whether those tasks are performed by him or on his
behalf. ◄

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2. GENERAL PRINCIPLES OF GROUPING

R2 ►
Medical devices that can be grouped into one of the grouping categories
specified in this GN-12-1 and also in GN-12-2 guidance documents can be
submitted in one product registration application.

Grouping of medical devices is for the purpose of product registration

submission. The listing of registered medical devices on the Singapore Medical
Device Register (SMDR) upon approval may differ from the initial submitted
grouping. For example, medical devices with different proprietary names or
brand names may be submitted in one product registration application if they
meet any of the grouping categories defined in this GN-12-1 or the GN-12-2
guidance documents. However, the devices with different proprietary names or
brand names will be listed separately under different device listings on the
SMDR.

The product owner of a medical device may incorporate as part of their device,
medical devices and/or accessories from other manufacturers or product
owners or intend such devices to be used together to achieve a common
intended purpose. By such design and/or intended purpose, the product owner
of the medical device also assumes the responsibility for such use of the other
devices and accessories.

Existing regulatory requirements apply to all medical devices to be registered,

regardless of the manner in which they are grouped for product registration
submission. Information on all medical devices within a grouping must be
submitted as part of the dossier/application for registration, such as
authorisation from all medical device product owners for registration and data
to substantiate the performance of these devices.

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MEDICAL DEVICE GUIDANCE NOVEMBER 2017

Once the medical device(s) is deemed registrable, the final appropriate device
listing information on the SMDR shall be determined by HSA. For example,
where submissions with device groupings which allow for
instruments/accessories from different product owners, such as IVD analysers,
only the product owner of the primary device will be listed on the SMDR,
although the documentation relating to other product owners are required to be
submitted as part of the registration submission. Only registered medical
devices listed on the SMDR shall be supplied on the market.

The Registrant shall undertake the following post-market duties and obligations
for all medical devices and accessories they have registered on the SMDR
either individually or as part of grouped registrations:
 comply with the conditions applicable to the registered medical device and
conditions imposed on the Registrant;
 submit applications to the Authority for changes made to the registered
medical device;
 maintain records of supply;
 maintain records of complaints;
 report defects and adverse effects to the Authority; and
 notify the Authority concerning field safety corrective action (FSCA),
including recall. ◄

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MEDICAL DEVICE GUIDANCE NOVEMBER 2017

3. GROUPING CATEGORIES

3.1. FAMILY

A medical device FAMILY is a collection of medical devices and each medical

device FAMILY member:
 is from the same product owner;
 is of the same risk classification;
 has a common intended purpose;
 has R2 ► a common ◄ design and manufacturing process; and
 has variations that are within the scope of the permissible variants.

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LIST OF PERMISSIBLE VARIANTS IN A FAMILY

The list of permissible variants is a closed list.

Specific products Permissible variants

R2 ► Abutments Retention (e.g. cement or screw)

R2 ► Active
MR conditional and Non- MR Conditional
Implantable Devices

Antibiotic test (IVD) Concentration

R2 ► Biopsy Forceps Formable or Non-formable

R2 ► Blood Bags (i) Anticoagulants with same composition but

different concentrations
(ii) Additives (different composition and
concentrations)

R2 ► Catheter (i) Number of lumens in catheter

(ii) Material of catheter: PVC (polyvinylchloride),
PU (polyurethane), nylon and silicone
(iii) Curvature
(iv) Coating material for lubrication

Condoms (i) Texture

(ii) Flavour

R2 ► Contact lens (i) Diopter,

(ii) UV protection
(iii) Tinting
(iv) Colour
(v) Wearing schedule (i.e. daily wear, extended
wear)
(vi) Replacement schedule (i.e. daily, weekly,
monthly)

R2 ► Defibrillators Automatic or semi-automatic

Dental brackets Material of bracket

Dental handpieces (i) Rotational speed

(ii) Material of handpiece

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Specific products Permissible variants

R2 ► Dermal fillers Same composition but different

concentrations/densities

R2 ► Diagnostic (i) Number of slices

Radiographic systems (ii) Digital vs Analog
(iii) Biplane and Single Plane
(iv) Flat Panel vs Cassette
(v) PET ring size

Electrophysiological (i) Electrode spacing

Catheter (ii) Number of electrodes

R2 ► Gloves Powdered or powder-free

R2 ► Gamma Camera Number of detectors

R2 ► Guide wire With or without inert coating material

R2 ► Orthopaedic/ (i) Cemented or non-cemented fixation

Dental Implants (ii) Collar

R2 ► Intra-ocular Lens (i) Monofocal or Multifocal

(ii) Multi-piece or Single-piece
(iii) Aspheric or Spheric

R2 ► Implantable
Number of Chambers (Cardio)
Pulse Generators

IV Cannula (i) Presence of injection port

(ii) Presence of safety wing

IVD rapid tests Different assembly format: cassette, midstream,

strip

IVD urinalysis strips Different combination of testing configurations

R2 ► Polymer
With or without plasticisers (e.g. DEHP)
products

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Specific products Permissible variants

R2 ► Stent (i) Delivery system, that is over-the-wire or

through the scope
(ii) Flaps, Flares or sleeves

R2 ► Suture (i) Number of strands

(ii) Pledgets
(iii) Loops
(iv) Dyes

Suture passer Design of jaw, handle or needle

R2 ► Tracheal Tube With or without cuff

(endotracheal tube,
tracheostomy tube)

R2 ►Wound Dressings Different formats (e.g. solution, creams, gels loaded

onto pads, etc)

R2 ► X-ray detector Scintillator material

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Other permissible variants in general

R2 ► Coating material for lubrication only

Colour

Diameter, Length, Width, Gauge

R2 ► Concentration with same indication and mechanism (same

composition different amount of constituent)

Dimensional design differences due to paediatric versus adult use (The

differences due to the different patient population are permissible, e.g.
volume and length)

Flexibility

Holding force

Isotope activity level

Memory storage

R2 ► Method of Sterilisation (to achieve same sterility outcome)

Printing capability

Radiopacity

Shape, Size, Volume

Viscosity (The change in viscosity is solely due to changes in the

concentration of constituent material)

Type of device mounting (e.g. ceiling mount, wall mount or standing)

R2 ► Sterility status (sterile vs non-sterile)

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Decision Flowchart for Grouping of Medical Devices as a FAMILY

From same No
product owner?

Yes

Same risk No
classification?

Yes

No
Common intended
purpose?

Yes

Common No
design and
manufacturing
process?

Yes

No Cannot be
Variations submitted as a
within permissible FAMILY.
variants?

Yes

Can be submitted as one

FAMILY application.
(members of the FAMILY will
be listed separately based on
their proprietary names)

R2 ► When medical devices satisfy the FAMILY conditions to be grouped as

one product registration submission, but have different device proprietary

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names or brand names, the device models will be listed separately on the
SMDR based on their proprietary names upon approval of the application.

Addition of New Models to a FAMILY Listing on the SMDR

The addition of new medical devices to an SMDR device listing through a
CHANGE NOTIFICATION is only permissible if the new medical devices being
added carry the same device proprietary name or brand name as the SMDR-
listed medical devices. Although, the new medical devices may satisfy the
criteria to be grouped as a FAMILY with the registered medical devices, a new
product registration application has to be submitted for the registration of these
new medical devices that have different proprietary names from those
registered on the SMDR. Kindly refer to GN-21 Guidance on Change
Notification for Registered Medical Devices for more information. ◄

Examples:
R2 ►
 Condoms that differ in colour, size and texture but are manufactured from
the same material, using common manufacturing process and share a
common intended purpose can be grouped as a FAMILY.
 IV administrative sets that differ in features such as safety wings and
length of tubing, but are manufactured from the same material, common
manufacturing process and share a common intended purpose can be
grouped as a FAMILY.
 Steerable guidewires that are available in various lengths and possess
various tip shapes and tip flexibilities can be grouped as a FAMILY if their
variations fall within the scope of permissible variants.
 Cardiac catheters that are available in a different number of lumens,
lengths and diameters can be grouped as a FAMILY.
 Contact lenses with additional features of UV protection can be grouped
as a FAMILY, as this feature does not affect the basic design and
manufacturing of the lens. ◄

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 Contact lenses are available as toric lens or spherical lens. These products
have different intended purposes and performances. They are designed and
manufactured differently. Due to these differences, they shall not be
considered as members of a FAMILY.

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3.2. SYSTEM

R2 ► A medical device SYSTEM comprises of a number of medical devices

and/or accessories that are:
 from the same product owner;
 intended to be used in combination to achieve a common intended purpose;
 compatible when used as a SYSTEM; and
 sold under a single SYSTEM name or the labelling, IFU, brochures or
catalogues for each constituent component indicates that the constituent
component is intended to be used together or for use with the SYSTEM.

Devices registered as part of a SYSTEM shall only be supplied specifically for

use with that SYSTEM. Any device that is meant for supply for use with multiple
SYSTEMs should be registered together with each of these other SYSTEMs.
Alternatively, if these devices are compatible for use with one or multiple
SYSTEMs from different product owners, they can be registered separately. ◄

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Decision Flowchart for Grouping of Medical Devices as a SYSTEM

From same No
product owner?

Yes

Intended
to be used in No
combination to achieve
a common intended
purpose?

Yes

Compatible No Cannot be submitted

when used as as a SYSTEM
a SYSTEM?

No
Yes

Labelling for
Sold under a No
constituent components is
single
intended for use as a
SYSTEM
SYSTEM?
name?

Yes
Yes

Can be submitted as
one SYSTEM
application

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R2 ► A product owner of a medical device SYSTEM may incorporate medical

devices and/or accessories from other product owners (or manufacturers) as
part of their SYSTEM to achieve the intended purpose of the device. These
medical devices and/or accessories should be grouped together as a SYSTEM,
and information on all these devices and accessories, such as authorisation
from their product owners for registration with the SYSTEM, evidence on use
and compatibility with the SYSTEM shall be submitted.

Example:
A patient monitoring SYSTEM from product owner A is intended to be used
specifically with vital signs sensors and probes from product owner B. These
accessories are used in combination to achieve a common intended purpose in
accordance with product owner A’s specifications, and can be grouped
together with the patient monitoring SYSTEM in one application for registration.
◄

In addition, if multiple SYSTEMs fulfil the following conditions to be grouped as

a FAMILY, they may be grouped as a FAMILY (of SYSTEMs):
 the SYSTEMs are from the same product owner;
 the SYSTEMs are of the same risk classification;
 the SYSTEMs have a common intended purpose;
 the SYSTEMs have R2 ► a common ◄design and manufacturing process;
and
 key constituent components of the SYSTEMs have variations that are within
the scope of the permissible variants.

Individual SYSTEM names may contain additional descriptive phrases.

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FAMILY: HSA Zen Orthopaedic System

SYSTEM: SYSTEM: SYSTEM:

HSA Zen HSA Zen HSA Zen
Orthopaedic Orthopaedic Orthopaedic
System 1: System 2: System 3:
- Plates - Plates - Plates
- Rods - Rods - Rods
- Screws - Screws - Screws
- Instruments - Instruments - Instruments

NOTE The key constituent-components, i.e. implantable rods, plates and screws, across
the SYSTEMs are within the permissible variants. For example, differences in lengths of
the implantable screws are deemed permissible variants.

Figure 1 Example on Grouping of SYSTEMS as a FAMILY.

Examples:
 R2 ► A hip replacement SYSTEM comprising of femoral and acetabular
components can be grouped as a SYSTEM. The components must be used
in combination to achieve a common intended purpose of total hip
replacement. The size of the components may vary.
 An electrosurgical unit and its accessories that consist of forceps,
electrodes, electrode holders, leads, plug adaptor, when used together for
a common intended purpose, can be grouped as a SYSTEM.
 A catheter placement set/kit comprising of scalpels, syringes, needles,
surgical gloves, gauze, drapes and flushing solution that is validated for
compatibility and assembled by a single product owner under a single
SYSTEM name for use in combination during a surgical catheter placement
procedure can be grouped as a SYSTEM.
 Automated blood pressure monitors with optional features such as
memory storage and print capability for various models can be considered
as part of a FAMILY of SYSTEMS. ◄

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3.3. IVD TEST KIT

An IVD TEST KIT is an in vitro diagnostic (IVD) device that consists of reagents
or articles that are:
 from the same product owner;
 intended to be used in combination to complete a specific intended purpose;
 sold under a single TEST KIT name or the labeling, instructions for use
(IFU), brochures or catalogues for each reagents or article states that the
component is intended for use with the IVD TEST KIT; and
 compatible when used as a TEST KIT.

An IVD TEST KIT does not include the instruments, such as analysers, needed
to perform the test.

An IVD Medical Device SYSTEM may typically consist of TEST KITs and
instruments (e.g. an analyser designed to be used with that TEST KIT).
R2.1 ► An IVD TEST KIT and its accompanying IVD analyser can be listed
together as an IVD SYSTEM or the IVD analyser can be listed separately from
the IVD TEST KIT(s) as a SPLIT listing. Kindly refer to GN-34 Guidance
Document for IVD Analysers for further information on the listing of IVD
analysers that are supplied as part of an IVD SYSTEM. ◄

Example:
 A glucose monitoring SYSTEM comprising of a glucose meter, test strips,
control solutions and linearity solutions can be grouped as a SYSTEM.

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Decision Flowchart for Grouping of Medical Devices as an IVD TEST KIT

From same No
product owner?

Yes

No
Intended to be used in
combination to complete
a specific intended
purpose?

Yes

Reagents and No Cannot be

articles compatible as an submitted as
IVD TEST KIT (exclude an IVD TEST
instruments)? KIT application.

No
Yes

No Labelling
Sold under a single for reagents and articles
IVD TEST KIT stating intended for use with
name? the IVD TEST KIT?

Yes
Yes

Can be submitted as
one IVD TEST KIT
application

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Individual reagents or articles can be supplied separately as replacement items

for the kit. If the reagents or articles in a TEST KIT are supplied for use in more
than one TEST KIT, such reagents or articles shall be included in the product
registration application of each of the other TEST KITS.

R2 ► Reagents or articles from another product owner may be grouped with

the IVD TEST KIT if the applicant furnishes all information on these reagents or
articles required for registration, such as authorisation from the other product
owners for registration and data to substantiate the performance of these
reagents when used in the test kit. ◄

Example:
 A Human Immunodeficiency Virus (HIV) Enzyme Linked
ImmunoSorbent Assay (ELISA) TEST KIT may contain controls,
calibrators and washing buffers. All the reagents and articles are used
together to detect HIV and therefore can be grouped as a TEST KIT. These
reagents and articles can be supplied separately as replacement items for
that particular TEST KIT.

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3.4. IVD CLUSTER

An IVD CLUSTER comprises of a number of in vitro diagnostic reagents or

articles that are:
 from the same product owner;
 R2 ► is of the same risk classification (either Class A only or Class B only);
◄
 of a common test methodology as listed below; and
 of the same IVD CLUSTER category as listed below.

The IVD CLUSTER may include analysers that are designed for use with the
reagents in the IVD CLUSTER.

R2 ► The listing of the IVD test kits, reagents and their accessories on the
SMDR upon approval may differ from the initial grouping. Individual (SINGLE)
reagents or articles, test kits, FAMILY of reagents or articles within an IVD
CLUSTER shall be listed separately on the SMDR. The different device
proprietary names or brand names, and common intended purpose of the
products and analytes would be key considerations for the separate listings.

R2.1 ► Where IVD CLUSTERS also include the compatible IVD analyser(s),
an IVD TEST KIT and its accompanying IVD analyser can be listed together as
an IVD SYSTEM or the IVD analyser can be listed separately from the IVD
TEST KIT(s) as a SPLIT listing. Kindly refer to GN-34 Guidance Document for
IVD Analysers for further information on listing options of IVD analysers. ◄

The IVD CLUSTER grouping is only to be used for product registration and
would not be applicable as a grouping criterion for the addition of models
through a Change Notification. Kindly refer to GN-21 Guidance on Change
Notification for Registered Medical Devices for more information. ◄

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LIST OF IVD CLUSTER CATEGORIES

This list of IVD CLUSTER categories is only applicable to R2 ► Class A only
or Class B only IVD devices. ◄ It should be clearly stated in the label or IFU
of each reagent or article that it is intended for use, whether alone or in
combination, for the same category:

S/N Methodology CLUSTER Category Examples of Analytes

(closed list) (non-exhaustive list)

1 Clinical Chemistry Enzymes (i) Acid Phosphatase

(ii) Alpha-Amylase
(iii) Creatine Kinase
(iv) Gamma-Glutamyl Transferase
(v) Lactate Dehydrogenase
(vi) Lipase

2 Substrates (i) Albumin

(ii) Bilirubin
(iii) Urea/Blood Urea Nitrogen
(iv) Cholesterol
(v) Creatinine
(vi) Glucose

3 Electrolytes (i) Ammonia

Reagents
(ii) Bicarbonate
(iii) Calcium
(iv) Chloride
(v) Magnesium
(vi) Phosphate Inorganic/Phosphorus

4 Electrolyte (i) Ammonia Electrodes

Electrodes
(ii) Carbon Dioxide (Bicarbonate)
Electrodes
(iii) Calcium Electrodes
(iv) Chloride Electrodes
(v) Magnesium Electrodes
(vi) Potassium Electrodes

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S/N Methodology CLUSTER Category Examples of Analytes

(closed list) (non-exhaustive list)

5 Substrate (i) Creatinine Electrodes

Electrodes/
(ii) Glucose Electrodes
Biosensors
(iii) Glycated Hemoglobin Electrodes
(iv) Lactate Electrodes
(v) Urea Electrodes
(vi) Bilirubin Electrodes

6 Immunochemistry Immunoglobulins (i) Immunoglobulin A

(without IgE).
(ii) Immunoglobulin D
(iii) Immunoglobulin G
(iv) Immunoglobulin M
R2 ►
(v) Immunofixation kits

7 Complement (i) Complement Component C1q

Components
(ii) Complement Component C1
inactivator
(iii) Complement Component C3/C3c
(iv) Complement Component for Bb
(v) Complement Component C4
(vi) Complement Component C5a

8 Transport Proteins (i) Albumin

(ii) Ceruloplasmin
(iii) Haptoglobin
(iv) Hemopixin
(v) Lactoferrin
(vi) Pre-albumin/Transthyretin

9 Lipoproteins (i) Apolipoprotein A I

(ii) Apolipoprotein A II
(iii) Apolipoprotein B
(iv) Apolipoprotein E Sub-typing
(v) Lipoprotein (a)

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S/N Methodology CLUSTER Category Examples of Analytes

(closed list) (non-exhaustive list)

10 Other Specific (i) a1-Acid Glycoprotein

Proteins
(ii) a1-Antitrypsin
(iii) R2► a1-Microglobulin
(iv) Fibronectin
(v) Immuno Reactive Trypsin

11 Allergy (i) Immunoglobulin E – Total

(ii) Immunoglobulin E – Screen
(iii) Immunoglobulin E – Specific,
monotest/monoresult
(iv) R2► Allergen specific IgA
(v) R2► Allergen specific IgG

12 Cancer markers R2 ►
(i) GI-marker CA242
(ii) p53
R2 ►

13 Thyroid Function (i) Free Triiodothyronine

Markers
(ii) Free Thyroxine
(iii) Thyroid Stimulating Hormone
(iv) T – Uptake
(v) Thyroglobulin
(vi) Neonatal Thyroxine

14 Fertility/Pregnancy (i) Androstenedione

Hormones/ Proteins
(ii) Estradiol
(iii) Prolactin
R2 ►
(iv) Human Placental Lactogen
(v) Estriol

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S/N Methodology CLUSTER Category Examples of Analytes

(closed list) (non-exhaustive list)

15 Diabetes Assays (i) C-Peptide

(Hormones)
(ii) Glucagon
(iii) Insulin
(iv) Glycosylated/Glycated
Haemoglobin
(v) Islet Cell Ab
(vi) Proinsulin

16 Renal Metabolism (i) Aldosterone

Assays
(ii) Angiotensin I / II
(iii) Angiotensin Converting Enzyme
(iv) Cortisol
(v) Renine

17 Bone and Mineral (i) Bone Alkaline Phosphatase

Metabolism Assays
(ii) Calcitonin
(iii) Cross-linked C-Telopeptides
(iv) Cross-linkded N-Telopeptides
(v) Cyclic Adenosin Monophosphate
(vi) Hydroxyproline

18 Endocrine Hormones (i) Adrenocorticotropic Hormone

and Peptides
(ii) Human Growth Hormone
(iii) Insulin-like Growth Factor I
(iv) Insulin-like Growth Factor
Binding Protein 1
(v) Vasointestinal Peptide
(vi) Vasopressin

19 Neuroendocrine (i) Bombesin

Function Assays
(ii) 17-Hydroxy-Ketosterone
(iii) β-Endorphin
(iv) Neurotensin
(v) Somatostatin
(vi) Substance P

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S/N Methodology CLUSTER Category Examples of Analytes

(closed list) (non-exhaustive list)

20 Other Individual and (i) Gastrin

Specified Hormones
(ii) Gonadotropin-Releasing
Hormone
(iii) R2► Melatonin
(iv) Pepsinogen
(v) Adrenalin
(vi) Dopamine

21 Anaemia (i) Erythropoietin

(ii) Ferritin
(iii) Folate
(iv) Iron
(v) Iron Binding Capacity
(vi) Soluble Transferrin Receptor

22 Vitamins (i) Vitamin B1

(ii) Vitamin B2
(iii) Vitamin B6
(iv) Vitamin B12
(v) Vitamin D (Cholecalciferol)
(vi) Intrinsic Factor (Blocking
Antibody)

23 R2► Drug R2 ►
Monitoring
(i) Caffeine
(ii) R2► Benzodiazepines
(iii) R2► Penicillins
(iv) R2► Tetracyclines

R2 ► R2 ►

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MEDICAL DEVICE GUIDANCE NOVEMBER 2017

S/N Methodology CLUSTER Category Examples of Analytes

(closed list) (non-exhaustive list)

24 Toxicology (i) Amphetamines

(ii) Cocaine
R2 ►
(iii) R2► Morphine
(iv) Phencyclidine
(v) Acetaminophen
(vi) Catecholamines
(vii) Ethanol
(viii) Salicylate

25 Auto-immune (i) Anti-nuclear antibodies (ANAs)

Diseases
(ii) Anti-topoisomerase
(iii) Organ-specific autoantibodies
(iv) Circulating Immuno-complex
(v) TSH Receptor antibodies
(vi) Anti-Cardiolipin antibodies

26 Rheumatoid- (i) Anti-Streptococcal Hyaluronidase

Inflammatory
(ii) Anti-Streptokinase
Diseases Markers
(iii) Anti-Streptolysin O
(iv) C-Reactive Protein
(v) Anti-Staphylolysin
(vi) Anti-Streptococcal Screening

27 Liver Function (i) MEGX

(ii) Carbohydrate Deficient
Transferrin

28 Cardiac Markers R2 ►
(i) Homocysteine
(ii) R2► ST2
(iii) R2► Galectin-3
(iv) R2► Myeloperoxidase (MPO)

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S/N Methodology CLUSTER Category Examples of Analytes

(closed list) (non-exhaustive list)

29 Bacterial Infection - (i) Bacillus subtilis

Immunology
R2 ►
(ii) R2► Pseudomonas Aeruginosa
(iii) R2► Helicobacter Pylori
(iv) R2► Lactobacillus casei

30 Viral Infection - (i) R2► Norovirus

Immunology
(ii) R2► Rotavirus
(iii) R2► Hantavirus

31 Parasitic Infection - R2 ►
Immunology
(i) Leishmania

32 Fungal Infection - (i) Candida albicans

Immunology
(ii) Aspergillus

33 Haematology/ Hemoglobin Testing (i) Hemoglobin determinations

Histology/ (Total Hb)
Cytology
(ii) Fractional oxyhemoglobin
(FO2Hb)
(Blood tests for (iii) Fractional carboxyhemoglobin
transfusions (FCOHb)
excluded)
(iv) Fractional methemoglobin
(FMetHb)
(v) Fractional deoxyhemoglobin
(FHHb)

34 General Coagulation (i) Prothrombin Time

Tests
(ii) Thrombin Time
(iii) Activated Clotting Time
(iv) Activated Partial Thromboplastin
Time

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S/N Methodology CLUSTER Category Examples of Analytes

(closed list) (non-exhaustive list)

35 Haemostasis R2 ►
(Coagulation)
(i) Fibrinogen
(ii) Protein C and Protein S reagents
(iii) C1-inhibitors
R2 ►
(iv) Alpha-Antiplasmin
(v) Fibrin
(vi) Factor XIII
(vii) Platelet Factor 4
(viii) Plasminogen

36 Other Hematology (i) Complete Blood count

Tests
(ii) Hematocrit
(iii) Erythrocyte Sedimentation rate

37 Cytokines (i) Interferons

(Lymphokines)/
(ii) Soluble Antigens/Receptors
Immunomodulators
(iii) Tumor Necrosis Factors
R2 ►
(iv) Colony Stimulating Factors
(v) Tumor Necrosis Factors
Receptors
R2 ►

38 Histology/ Cytology (i) Cytochemical Staining

Reagents
(ii) Embedding, Fixing, Mounting
media
(iii) Stain solutions
(iv) Immunohistology kits

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S/N Methodology CLUSTER Category Examples of Analytes

(closed list) (non-exhaustive list)

39 Microbiology - Culture Media (i) Dehydrated culture media (DCM)

culture
(ii) Additives for DCM
(iii) Prepared Media (Tubes, bottles,
Plates)
(iv) Cells, Media, Serum for Viral
culture

40 Susceptibility Testing (i) Erythromycin susceptibility test

for Staphylococcus aureus
Testing for the
susceptibility of the (ii) Tobramycin susceptibility test for
bacteria to certain Pseudomonas aeruginosa
antibiotics.
(iii) Fungal susceptibility testing

41 Biochemical culture (i) Gram Negative Manual ID

Identification (ID)
(ii) Gram Positive Manual ID
(iii) Other ID Kits Manual -
Anaerobes, Fastidious
R2 ►

42 Immunological (i) Streptococci Grouping Slide tests

culture Identification
(ID) (ii) Serotyping (R2 ► Shigella
etc.)

43 Nucleic Acid (NA) R2 ►

based culture
identification (ID) (i) Streptococci
(ii) Shigella

44 Serological (i) For Parasitology and Mycology

identification (ID) (Fungi and Yeast)

R2 ► R2 ►

45 Bacterial Infections R2 ►
(Detection by NA (i) Streptococci
Reagents)
(ii) Shigella

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MEDICAL DEVICE GUIDANCE NOVEMBER 2017

S/N Methodology CLUSTER Category Examples of Analytes

(closed list) (non-exhaustive list)

Viral Infections
46 R2 ►
(Detection by NA
Reagents) (i) Para-influenza NA Reagents

47 Fungal Infections (i) Fungi NA Reagents

(ii) R2 ► Candida albicans
(iii) R2 ► Aspergillus

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MEDICAL DEVICE GUIDANCE NOVEMBER 2017

Decision Flowchart for Grouping of Medical Devices as an IVD CLUSTER

From same No
product owner?

Yes

Within the risk No

classification of
Class A or Class B?

Yes

Reagents or articles
No Cannot be
of common test
methodology and within submitted as an IVD
listed IVD CLUSTER CLUSTER
category? application

Yes

Can be submitted as
one IVD CLUSTER
application

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MEDICAL DEVICE GUIDANCE NOVEMBER 2017

Information on all reagents or articles within R2 ►an IVD CLUSTER must be

submitted as part of the product registration application. Devices and articles
that are listed as part of a CLUSTER can be supplied separately but solely for
the registered intended purpose. ◄

If a reagent or article is intended for multiple usage categories such that it can
be grouped in more than one IVD CLUSTER, the Registrant can choose to
group the reagent or article as part of any one of the IVD CLUSTERs it qualifies.
Information to support all the intended purposes of the reagent or article must
be submitted as part of the product registration application.

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MEDICAL DEVICE GUIDANCE NOVEMBER 2017

Example:
Product Owner is “HSA”
1 Class B IVD CLUSTER
Category
(e.g. Enzymes)

HSA ABC Test Kit HSA ABC Test Kit HSA ZEN Reagents HSA ZEN Reagents
for enzyme A for enzyme B for enzyme B for enzyme C

Figure 2 Example of a Class B IVD CLUSTER grouping with 4 IVD products within the
CLUSTER category - Enzymes

Based on the example, the 4 IVD products qualify to be submitted as one IVD
CLUSTER category (Enzymes) and would be listed as 4 SMDR listings:

1. HSA ABC Test Kit for enzyme A*

2. HSA ABC Test Kit for enzyme B**
3. HSA ZEN Reagent for enzyme B***
4. HSA ZEN Reagent for enzyme C****

* HSA ABC Test Kit for enzyme A is under one listing in which HSA is the product owner and ABC is the
proprietary name.
** HSA ABC Test Kit for enzyme B is under one listing in which HSA is the product owner and ABC is the
proprietary name.
*** HSA ZEN Reagent for enzyme B is under one listing in which HSA is the product owner and ZEN is
the proprietary name.
**** HSA ZEN Reagent for enzyme C is under one listing in which HSA is the product owner and ZEN is
the proprietary name.

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MEDICAL DEVICE GUIDANCE NOVEMBER 2017

3.5. GROUP

R2 ► A medical device GROUP is a collection of two or more medical devices,

that is labelled and supplied in a single packaged unit by a product owner.
The medical device GROUP comprises of the following:
 a single proprietary GROUP name;
 labelled and supplied in a single packaged unit by the product owner; and
 a common intended purpose.

For the purposes of grouping for product registration, the collection of medical
devices in a GROUP is the closed list of devices included in a product
registration submission. This closed list of medical devices in a GROUP (single
packaged unit) may differ in the number (quantity) and combination
(permutation within the closed list) of products that comprise the GROUP, while
maintaining the same proprietary GROUP name and the GROUP’s intended
purpose.

Typically, for a medical device GROUP, the product owner intends to supply a
collection of customised medical devices for a specific medical purpose within
a single packed unit, such as a convenience pack or tray, which is under a
single name.

A product owner of the GROUP who assembles a GROUP together also

assumes responsibility for the medical device GROUP and its intended
purpose. The product owner of a medical device GROUP may incorporate
medical devices obtained from other manufacturers/product owners as part of
their GROUP to achieve the common intended purpose. In manufacturing and
assembling this GROUP of medical devices, the evidence to substantiate the
safety, quality and efficacy of the collection of devices shall be provided in the
submission. Relevant information for submission may include sterility, shelf life,
evidence on use and compatibility as a GROUP, quality management systems,
etc. Labelling, particularly the instructions for use (IFU), where applicable, shall
clearly describe the common intended purpose of the GROUP.

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MEDICAL DEVICE GUIDANCE NOVEMBER 2017

Only medical devices within a GROUP that are eventually listed on the SMDR
shall be supplied on the market as a single packaged unit under the GROUP
name. The single packaged unit identifier would also be listed on the SMDR,
where the single packaged units bear unique/different product identifiers; these
shall be listed on the SMDR as well. Medical devices that are registered within
a GROUP must have a SINGLE medical device registration before they are
sold separately as individual medical devices for their specific individual
intended purpose or as replacements. ◄

If a medical device in a GROUP is supplied for use in another GROUP, such a

medical device shall be included in the registration application of that other
GROUP.

R2 ► When the GROUP is registered, the product owner is able to customise

for supply, in a single packaged unit, from the closed list of devices for particular
hospitals or physicians, while maintaining the same GROUP name and
intended purpose. Thus, when the medical device GROUP is registered, any
other single packaged unit combination (permutation of devices within the
closed list) of devices in that GROUP can be supplied on the market for the
registered intended purpose of the GROUP. ◄

The GROUP name indicated for the medical device must appear in the product
label affixed on the external package of the GROUP. R2 ► The content list of
devices within the single packaged unit for supply should also appear on the
external package of the GROUP or supplied with the GROUP. ◄ Individual
medical devices in the GROUP do not require to be labelled with that GROUP
name. Individual medical devices in the GROUP may contain additional
descriptive phrases.

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MEDICAL DEVICE GUIDANCE NOVEMBER 2017

Examples:
 A first aid kit consisting of medical devices such as bandages, gauzes,
drapes and thermometers, when assembled together as one package for a
common medical purpose by a product owner, can be grouped as a
GROUP.
 A product owner supplies dressing trays customised with different
quantity and type of gauze and sutures to different hospitals. R2 ► When
the closed list of medical devices in the GROUP are registered, the product
owner is able to customise the trays, from the list of devices, for other
hospitals, while maintaining the same GROUP name for the trays and the
registered intended purpose. The product label for the trays shall bear the
content list of devices within the package for supply. Some of the medical
devices in the GROUP may be individually packaged and labelled, while
others remain in bulk form and may not be labelled. The product owner shall
account for these during the assembling of the GROUP and ensure
compliance to existing regulatory requirements including traceability of
individual devices packaged into the trays and record keeping. ◄
 A promotional pack or convenience pack, without a GROUP name and
without a common medical intended purpose, consisting of different number
of medical devices, for example multi-purpose solution, saline solution, and
contact lens case, will NOT qualify as a GROUP registration. Individual
medical devices shall require registration as SINGLE medical devices.

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MEDICAL DEVICE GUIDANCE NOVEMBER 2017

Decision Flowchart for Grouping of Medical Devices as a GROUP

Collection of two
or more medical
devices?

Yes

No
Single proprietary
GROUP name?

Yes

Labelled &
No
supplied in a single
packaged unit by
the product owner?

Yes

No
Common GROUP Cannot be submitted
intended purpose? as a GROUP
application

Yes

Can be submitted as
one GROUP
application

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MEDICAL DEVICE GUIDANCE NOVEMBER 2017

3.6. SINGLE

R2 ► A SINGLE medical device is a medical device from a product owner

identified by a medical device proprietary name or brand name with a specific
intended purpose. Medical devices that cannot be assigned to a FAMILY,
SYSTEM, IVD TEST KIT, IVD CLUSTER, GROUP or any other device specific
grouping category defined in the GN-12-2 guidance document must be
registered individually.

A SINGLE medical device is sold as a distinct packaged entity and may also be
offered in a range of package sizes. ◄

Examples:
 Condoms that are sold in packages of 3, 12 and 144 can be grouped as a
SINGLE medical device when submitting for registration.
 R2 ► A company manufactures a standalone software program that can be
used with a number of CT scanners produced by other product owners. The
standalone software program itself is deemed a medical device, which can
be used on different scanners. The software can be grouped as a SINGLE
medical device. ◄

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Contact Information:

Medical Devices Branch

Pre-marketing Cluster
Health Products Regulation Group
Health Sciences Authority

11 Biopolis Way, #11-03 Helios

Singapore 138667
www.hsa.gov.sg
Email: [email protected]