1. INTRODUCTION
1. INTRODUCTION R2 ►
1.1. Purpose
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
1.2. Background Under the Health Products Act 2007 (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 MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 6 of 30 and GN-12-2 guidance documents when preparing their medical device product registration submissions. ◄
1.3. Scope
1.3. Scope R3 ► This document is applicable to all device products that fall within the definition of a medical device found in the First Schedule of the Act. ◄
1.4. Definition
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 GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 7 of 30 MEDICAL DEVICE: means a medical device as described in the First Schedule of the Act. 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. ◄ MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 8 of 30
2. GENERAL PRINCIPLES OF GROUPING
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. MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 9 of 30 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. ◄ MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 10 of 30
3. GROUPING CATEGORIES
3. GROUPING CATEGORIES
3.1. FAMILY
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. MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 11 of 30 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 Implantable Devices MR conditional and Non- MR Conditional 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 MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 12 of 30 Specific products Permissible variants R2 ► Dermal fillers Same composition but different concentrations/densities R2 ► Diagnostic Radiographic systems (i) Number of slices (ii) Digital vs Analog (iii) Biplane and Single Plane (iv) Flat Panel vs Cassette (v) PET ring size Electrophysiological Catheter (i) Electrode spacing (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/ Dental Implants (i) Cemented or non-cemented fixation (ii) Collar R2 ► Intra-ocular Lens (i) Monofocal or Multifocal (ii) Multi-piece or Single-piece (iii) Aspheric or Spheric R2 ► Implantable Pulse Generators Number of Chambers (Cardio) 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 products With or without plasticisers (e.g. DEHP) MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 13 of 30 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 (endotracheal tube, tracheostomy tube) With or without cuff R2 ►Wound Dressings Different formats (e.g. solution, creams, gels loaded onto pads, etc) R2 ► X-ray detector Scintillator material MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 14 of 30 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) MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 15 of 30 Decision Flowchart for Grouping of Medical Devices as a FAMILY Yes No No From same product owner? Same risk classification? Common design and manufacturing process? Variations within permissible variants? Yes Yes Yes Yes No No No Can be submitted as one FAMILY application. (members of the FAMILY will be listed separately based on their proprietary names) Common intended purpose? Cannot be submitted as a FAMILY. MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 16 of 30 R2 ► When medical devices satisfy the FAMILY conditions to be grouped as one product registration submission, but have different device proprietary 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. MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 17 of 30 • 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. ◄ • 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. MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 18 of 30
3.2. SYSTEM
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. ◄ MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 19 of 30 Decision Flowchart for Grouping of Medical Devices as a SYSTEM Compatible when used as a SYSTEM? Sold under a single SYSTEM name? Can be submitted as one SYSTEM application Cannot be submitted as a SYSTEM No No No No Yes Yes Yes Yes Yes No Intended to be used in combination to achieve a common intended purpose? Labelling for constituent components is intended for use as a SYSTEM? From same product owner? MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 20 of 30 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. MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 21 of 30 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. ◄ FAMILY: HSA Zen Orthopaedic System 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. SYSTEM: HSA Zen Orthopaedic System 1: -Plates -Rods -Screws -Instruments SYSTEM: HSA Zen Orthopaedic System 2: -Plates -Rods -Screws -Instruments SYSTEM: HSA Zen Orthopaedic System 3: -Plates -Rods -Screws -Instruments MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 22 of 30
3.3. IVD TEST KIT
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. MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 23 of 30 Decision Flowchart for Grouping of Medical Devices as an IVD TEST KIT From same product owner? Can be submitted as one IVD TEST KIT application Cannot be submitted as an IVD TEST KIT application. No No No No No Yes Yes Yes Yes Yes Reagents and articles compatible as an IVD TEST KIT (exclude instruments)? Labelling for reagents and articles stating intended for use with the IVD TEST KIT? Intended to be used in combination to complete a specific intended purpose? Sold under a single IVD TEST KIT name? MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 24 of 30 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. R3 ► -- ◄ MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 25 of 30
3.4. GROUP
3.4. 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. MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 26 of 30 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. MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 27 of 30 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. MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 28 of 30 Decision Flowchart for Grouping of Medical Devices as a GROUP Collection of two or more medical devices? Can be submitted as one GROUP application Cannot be submitted as a GROUP application No No Yes Yes Yes Yes No Single proprietary GROUP name? Common GROUP intended purpose? Labelled & supplied in a single packaged unit by the product owner? MEDICAL DEVICE GUIDANCE June 2026 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 29 of 30
3.5. SINGLE
3.5. 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, 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. ◄ Contact Information: Medical Devices Cluster Health Products Regulation Group Health Sciences Authority 11 Biopolis Way, #11-03 Helios Singapore 138667 www.hsa.gov.sg