Device definition & scope by country

Since Law 21/2020, specified products without an intended medical purpose are regulated as devices, including products introduced into the body to modify anatomy (except tattoo/piercing products), subcutaneous dermal/mucosal filling substances, liposuction/lipolysis/lipoplasty devices, intense electromagnetic radiation skin devices (laser, IPL for skin renewal, tattoo or hair removal) and transcranial brain stimulation devices.

'Medical device' (pajisje mjekësore) is any instrument, apparatus, material or other item, used alone or in combination, whose intended action on/in the human body is achieved with the aid of pharmacological, immunological or metabolic means, intended for diagnosis, prevention, monitoring, treatment or alleviation of disease or injury, investigation, replacement or modification of anatomy or a physiological process, or control of conception. Accessories (aksesor), in vitro diagnostic devices (pajisje mjekësore e diagnostikimit in vitro), self test devices, active devices, active implantable devices and custom made devices (pajisje me porosi) are separately defined; accessories are treated as devices.

Standalone software is considered an active medical device under the classification rules; software that drives a device or influences its use is automatically classified in the same class as that device.

The single dossier format applies to all device types, explicitly including IVDs (dispositifs médicaux de diagnostic in vitro) and active implantable devices; the dossier must designate the device as, where relevant, a device containing a medicinal product, blood component, animal origin material, latex or phthalates, an active implantable, an IVD, or a custom made (sur mesure) device.

Décret 20 324 applies to dispositifs médicaux à usage de la médecine humaine as defined in Articles 212 and 213 of loi n° 18 11, covering every ready to use industrially manufactured device, whether imported or exported.

'Producto médico' under MERCOSUR GMC Res. 25/21 covers any instrument, apparatus, equipment, implant, in vitro diagnostic product, software, material or other article intended by the manufacturer for medical use in humans.

The concepts used in Chapter 10 of the Law on Medical Care and Services to the Population are used in the meanings established by the legal acts of the Eurasian Economic Union bodies in the field of circulation of medical devices. The chapter covers medical devices generally and names in vitro diagnostic medical devices expressly, both as devices divided into classes by risk of use and as a category for which the effectiveness assessment follows an interventional clinical laboratory study regime.

A medical device is defined in s 41BD of the Therapeutic Goods Act 1989; in vitro diagnostic (IVD) devices are medical devices whose definition is set out in the Therapeutic Goods (Medical Devices) Regulations 2002. Software and accessories meeting the definition are regulated as devices.

An Abgrenzungs und Klassifizierungsbeirat (delimitation and classification advisory board) is established at the Federal Ministry; it issues expert opinions (Gutachten) on whether a product meets the medical device/IVD definitions of Regulations (EU) 2017/745 / 2017/746 and, where applicable, on its classification, advising the Ministry and BASG; for device/medicinal product borderline cases it sits jointly with the delimitation commission under § 49a Arzneimittelgesetz; the applicant bears the cost of external experts.

For in house devices (health institution manufacturing under Art. 5(5) MDR), the Health Minister may by ordinance designate devices that may not be manufactured and used in health institutions, and may set detailed requirements for design, the manufacturing process and its documentation, and for the quality management system for in house production.

The Rules identify medical devices using the Global Medical Device Nomenclature (GMDN) — 'the international system of codes and terms adopted for the purpose of identifying medical devices' — and record the GMDN code in the state register. Accessories ('komplektləşdiricilər', defined as blocks, parts, elements, materials and spare parts that are not themselves the device or a device accessory but are intended by the manufacturer for use in or with the device) that are not independently usable are registered together with the device as a set, not separately.

Resolution No. (48) of 2020 defines a medical device as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment or alleviation of injury; investigation, replacement, modification or support of anatomy or a physiological process; supporting or sustaining life; control of conception; disinfection of medical devices; or providing information for medical or diagnostic purposes by in vitro examination of specimens from the human body and which does not achieve its primary intended action by pharmacological, immunological or metabolic means. IVDs are separately defined as devices intended for in vitro examination of specimens derived from the human body to provide diagnostic, monitoring or compatibility information.

The statutory definition of drug (ঔষধ) expressly includes medical device as clause (খ) of ধারা ২(৫), so medical devices are regulated under the drug regime of the Drugs and Cosmetics Act 2023.

Medical device (মেডিক্যাল ডিভাইস) means any instrument, apparatus, implement, machine, appliance, implant, diagnostic reagent (in vitro, in vivo and in silico reagent), software or similar or related article used, alone or in combination, for medical purposes in humans or animals; the Government may declare further devices and diagnostic reagents by gazette notification.

The Ministry of Health's commission on medical products (комиссия по медицинским изделиям) decides, among registration questions, the expediency of qualifying products as medical products.

'Medical products (медицинские изделия, изделия медицинского назначения, медицинская техника)' = any instruments, apparatus, appliances, equipment, materials and other products used for medical purposes alone or in combination, including accessories and special software, intended by the producer for provision of medical care.

Not subject to state registration: used/refurbished devices; devices produced in or imported into Belarus solely for sale abroad; components of registered devices; raw materials and components for device production; spare parts for repair; devices covered by a Ministry of Health permit for sale/use of unregistered devices; and devices imported by an individual for personal use.

A product is a medical product only if its functional purpose is not achieved by pharmacological, immunological, genetic or metabolic action on the human body (such action may, however, be supported by medicines).

Belgium implements the in house exemption (MDR Art. 5(5)) through the Royal Decree of 12 May 2021 (medical devices) and the Royal Decree of 14 September 2022 (IVDs), which specify the declaration content: device identification within the institution, description, EMDN code, Annex VIII classification and intended use. After FAMHP validation a 'declaration of manufacture' is automatically generated on the FAMHP web portal; no separate declaration is required and generated declarations are publicly searchable. In house devices may not be transferred to another legal entity.

statement: Bolivia defines a medical device, in the framework of DS 25235 Article 5 and the WHO/PAHO glossary, as any instrument, apparatus, implement, machine, contrivance, implant, material or other similar or related article, used alone or in combination, including accessories and software necessary for its correct application as proposed by the manufacturer, on human beings for diagnosis, prevention, monitoring, treatment or alleviation of disease or injury, investigation, replacement or support of anatomical structure or physiological process, support or sustaining of life, control of conception, disinfection of medical devices, or in vitro examination of samples derived from the human body, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means but may be assisted in its function by such means. · article: Numeral 1.6

statement: For harmonisation purposes and under the manual, all companies registered in the categories of insumos, miscellaneous products and dental products, and all sanitary registrations granted as miscellaneous that fall within the definition of a medical device, become considered as falling in the medical device category. · article: Numeral 1.6, final paragraph

Under the Act, medical devices are instruments, apparatus, material and other products applied to humans which do not achieve their principal intended action by pharmacological, immunological or metabolic means but are used alone or in combination — including the software needed for their proper use — for diagnosis, prevention, monitoring, treatment or alleviation of disease; for diagnosis, monitoring, treatment or alleviation of injury or disability; for investigation, replacement or modification of anatomical or physiological functions; or for control of conception. Products the manufacturer intended for use in combination with a device, devices made to the individual prescription of a specially qualified professional, and devices intended for clinical investigation are also counted as medical devices. In vitro diagnostic medical devices are defined separately as reagents, reagent kits, reagent products, control and calibration materials, instruments and equipment used in vitro on biological samples.

IVDs are treated as a subset of medical devices rather than a separate product category. BoMRA's Essential Principles guideline applies to 'all medical devices, including in vitro diagnostic medical devices', and separate IVD specific instruments exist for classification (BOMRA/ER/MED/P04/G06) and registration (BOMRA/ER/MED/P04/G09).

The operative definition of a medical device is the MRSA 2013 section 2 definition: an instrument, apparatus, implement, implant, medical equipment, machine, contrivance or other related article used in the diagnosis, mitigation, treatment or prevention of disease in man or animals, or used to affect the structure or function of the body of man or animals, and not achieving its principal intended purposes through chemical action in the body or by being metabolised.

RDC 751/2022 Art. 4º X defines 'dispositivo médico (produto médico)' broadly: any instrument, apparatus, equipment, implant, IVD, software, material or other article intended by the manufacturer for use in humans, alone or in combination.

No Brunei statute or regulation defines 'medical device' or 'in vitro diagnostic'. The Medicines Act's s. 4(1) definition of 'medicinal product' excludes 'an instrument, apparatus or appliance' and requires that the substance or article be for use by being administered to human beings or animals, or as an ingredient of something so administered, so neither devices nor reagents used outside the body fall within the Act's registration regime.

The ЗМИ definition of 'medical device' expressly includes software — an instrument, apparatus, device, software, material or other article used alone or in combination, including software.

Human blood, plasma or blood cells of human origin and devices incorporating them, transplants or tissues or cells of human origin and products incorporating or derived from them, and transplants or tissues or cells of animal origin are outside the device instrument, except where the material is incorporated in an IVD device, where human blood material is incorporated as a human blood derivative with an action ancillary to that of the device, or where the animal tissue is rendered non viable. Mass produced devices adapted to a practitioner's specific requirements are expressly not custom made devices.

The instrument binding Cambodia defines a 'medical device' as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material or other similar or related article intended by the product owner to be used on human beings for a listed medical purpose and which does not achieve its primary intended action by pharmacological, immunological or metabolic means; an 'accessory' is an article intended specifically to be used together with a particular device to enable or assist its use; accessories are treated as medical devices in their own right, and both are referred to as devices. The listed purposes expressly include providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body, so software and IVDs fall within the single definition.

The Medical Devices Regulations define 'medical device' as a device within the meaning of the Food and Drugs Act but exclude any device intended for use on animals; veterinary devices are therefore outside the medical device regime.

A device is an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, manufactured, sold or represented for use in: diagnosing, treating, mitigating or preventing disease/disorder/abnormal physical state; restoring, modifying or correcting body structure or function; diagnosing pregnancy; care during pregnancy/birth; or preventing conception.

Software that a medical device consists of or contains is within device scope: it must be designed to perform as intended by the manufacturer and its performance must be validated (MDR s.20).

For borderline products (between device, medicine, cosmetic, sanitary use pesticide, etc.), ISP determines the applicable sanitary control regime by reasoned resolution (resolución fundada), based on D.S. N°3 Article 8; the determination is made where doubt exists about classification given the product's characteristics and intended use.

D.S. N°825/1998 defines in vitro medical devices (dispositivos médicos in vitro) as any medical use article consisting of a reagent, reagent product, calibrator, control material, equipment, instrument, apparatus, equipment or system, intended by the manufacturer for in vitro examination of samples from the human body (including blood/tissue donations) to provide information on a physiological or pathological state, congenital anomaly, or safety/compatibility with potential recipients.

D.S. N°825/1998 defines a medical device (dispositivo médico / artículo de uso médico) as any instrument, apparatus, application, material or article, including software, used alone or in combination and defined by the manufacturer for direct use in humans, whose principal intended action is not achieved by pharmacological, immunological or metabolic means; purposes include diagnosis, prevention, monitoring, treatment or alleviation of disease, investigation, replacement/modification of anatomy or a physiological process, and contraception.

A medical device is any instrument, apparatus, implement, in vitro diagnostic reagent or calibrator, material or other similar or related item used directly or indirectly on the human body, including required computer software, whose action is obtained mainly by physical means and not by pharmacology, immunology or metabolism (which may play only an auxiliary role). IVD reagents, calibrators and software fall inside the device definition.

Decreto 4725 de 2005 regulates medical devices for human use at all stages and excludes IVD reagents and custom made devices (dispositivos médicos sobre medida) from its scope.

The legal definition of medical device for human use expressly includes software ('cualquier instrumento, aparato, máquina, software, equipo biomédico u otro artículo similar'), provided the principal action is not pharmacological, immunological or metabolic.

IVD reagents are regulated separately by Decreto 3770 de 2004: category III (high risk) requires registro sanitario from INVIMA; categories I and II obtain automatic registro sanitario.

Equipo biomédico de tecnología controlada is a distinct category subject to permiso de comercialización: devices under special control for high risk, prototypes, offer controlled technology, used or refurbished equipment, or equipment involving investment above 700 monthly minimum wages (SMMLV).

Equipo y Material Biomédico (EMB): any instrument, device, equipment, material or other article, used alone or in combination (including software involved in its operation), intended by the manufacturer for human use for diagnosis, prevention, control, treatment or alleviation of disease; injury/deficiency compensation; investigation, replacement or modification of anatomy or a physiological process; or conception control, plus products used to clean, condition, disinfect or sterilize an EMB, provided the principal action is not pharmacological, immunological or metabolic. Aesthetic treatment equipment, non corrective contact lenses and permanent makeup/tattoo instruments are included as EMB.

In vitro diagnostic devices (Equipo para diagnóstico "in vitro") are EMB including their reagents, calibrators, controls and consumables intended to examine or diagnose from samples or fluids obtained from the human body; IVDs that contain a medicine or serve as internal quality controls (including blood derivative based) are expressly in scope.

Software as Equipo Médico is software intended for medical purposes performing those purposes without being part of a physical device; it is an EMB (including IVD software), can run on general purpose computing platforms, and mobile apps meeting the definition are considered Software as Equipo Médico. Accessories and medical software receive identical treatment to EMB.

RTCR 505:2022 does not apply to medicines, human blood/blood products, cosmetics, human organs/tissues/cells and products made from them, general laboratory articles used only for research (unless intended by the manufacturer for IVD diagnosis), internationally certified reference materials, external quality assessment materials, and medical gas piping assembled on site. A product intended to administer a medicine is regulated under RTCR 505:2022 (the medicine under CA medicines rules); if device and medicine form an integrated single use product, the medicines regulation applies. Peritoneal dialysis fluids and contrast media are classified as medicines, not EMB.

Côte d'Ivoire applies, as a UEMOA member state, the harmonised definition of a medical device: any instrument, apparatus, equipment, material or other article, used alone or in combination, including the software necessary for its correct operation, intended by the manufacturer for use in humans for (i) diagnosis, prevention, monitoring, treatment or alleviation of disease; (ii) diagnosis, monitoring, treatment, alleviation or compensation of an injury or handicap; (iii) investigation, replacement or modification of anatomy or of a physiological process; or (iv) conception control — and whose principal intended action in or on the human body is not obtained by pharmacological, immunological or metabolic means, although its function may be assisted by such means. Products specifically intended for cleaning, disinfecting or sterilising such devices are also deemed medical devices. A separate definition covers the in vitro diagnostic medical device (DMDIV): a reagent, calibrator, control material, kit, instrument, apparatus, equipment, software or system, used alone or in combination, intended by the manufacturer for in vitro examination of samples from the human body, including blood and tissue donations, to provide information on a physiological or pathological state, on a congenital anomaly, on predisposition to a medical condition or disease, to determine safety and compatibility with potential recipients, or to monitor therapeutic measures. Products intended for general laboratory use are not IVDs unless, given their characteristics, they are specifically intended by their manufacturer for in vitro diagnostic examination.

Croatian law contains no independent definition of a medical device or an in vitro diagnostic medical device: the terms used in the implementing act have the same meaning as the terms used in Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Scope is therefore determined by Article 2 of the MDR and Article 2 of the IVDR, including the products without an intended medical purpose listed in MDR Annex XVI.

Dispositivo médico (DM) is defined as any instrument, apparatus, implement, machine, artifact, implant, in vitro reagent, software, material or other similar or related article intended by the manufacturer for use in humans for medical purposes such as diagnosis, prevention, control, treatment or alleviation of disease, or investigation, replacement or support of anatomy or a physiological process.

IVD medical devices are 'Dispositivo médico para diagnóstico in vitro (DMDIV)': devices intended by the manufacturer for in vitro analysis of samples derived from the human body to supply information for diagnosis, monitoring or compatibility. In Cuba they were previously identified as 'diagnosticadores'; in the DMDIV sense the term excludes software, sample containers and laboratory equipment, and covers reagents, calibrators and control materials.

Cyprus applies the Union definitions directly. CYMDA's definitions page reproduces the medical device definition of Article 2(1) of Regulation (EU) 2017/745 and the in vitro diagnostic medical device definition of Article 2(2) of Regulation (EU) 2017/746, and records that the MDR also applies, from the date of application of the common specifications adopted under Article 9, to the product groups without an intended medical purpose listed in Annex XVI, taking account of the latest technological developments and in particular the existing harmonised standards for analogous medical use products based on similar technology.

SÚKL decides whether a product is a medical device and determines its classification (borderline determinations), alongside registering devices in the national register.

Denmark applies the EU (MDR) definition of a medical device, including software; the delineation to medicines turns on the principal mode of action (devices act physically/mechanically, not pharmacologically, immunologically or metabolically). The national regulation covers devices and accessories under MDR, IVDs under IVDR, and Annex XVI products without a medical purpose covered by Implementing Regulation (EU) 2022/2346.

statement: Article 109 of the Ley General de Salud assigns the Ministry of Public Health, through the institutions created for the purpose, sanitary control of medical equipment, prostheses, orthoses, functional aids, diagnostic agents, dental use supplies, surgical and healing materials and hygiene products — covering the process, use, maintenance, import, export and final disposal of those goods. The law's glossary defines prostheses, orthoses and functional aids as devices intended to substitute for or complement a function, organ or tissue of the human body. · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: market oversight · localApplicationRequired: Yes · targetDecisionRetained: Yes

The 2026 norm defines in vitro diagnostic devices (DMDIV) as devices intended by the manufacturer for in vitro analysis of samples derived from the human body for diagnostic, monitoring or compatibility purposes; combined devices (device + drug in one product) are regulated as medicines when the principal action is pharmacological. Software with machine learning (MLMD) is defined as a device using machine learning wholly or partly to achieve its intended medical purpose.

Ley Orgánica de Salud defines medical devices as articles, instruments, apparatus or mechanical inventions, including components, parts and accessories, made, sold or recommended for use in diagnosis, curative or palliative treatment, prevention of disease, or to replace/modify anatomy or a physiological process; dental amalgams, varnishes and sealants are included.

IVD medical devices are defined as reagents, reagent products, calibrators, control materials, kits, instruments, apparatus, equipment or systems for in vitro examination of specimens derived from the human body; specimen receptacles are IVDs, while products for general laboratory use are not unless specifically intended for IVD examination.

Egypt defines a medical device as any instrument, apparatus, appliance, tool, application software, implant, material or other article intended for human medical purposes (diagnosis, prevention, monitoring, prediction, prognosis, treatment, alleviation of disease, etc.) that does not achieve its principal intended action by pharmacological, immunological or metabolic means. Software is explicitly in scope.

Ravimiamet has the power to determine that a product is a medical device where the product meets the requirements set out in Regulation (EU) 2017/745 or Regulation (EU) 2017/746 — that is, qualification follows the Union definition rather than a separate Estonian definition.

EFDA states expressly which borderline products it does not regulate as medical devices: products that do not fulfil the Art. 2(22) definition are not considered a medical device and are not regulated by the Authority as a medical device. The guideline's non exhaustive list of such products is multipurpose disinfectants or sterilisation agents that do not have medical use; general purpose products such as printers used with medical devices; devices used for non medical purposes such as breast pumps; products for sports or leisure such as gym equipment with a heart rate measuring function; personal protective equipment such as masks used to protect users from environmental pollution; and software such as telecare alarm systems. Products fulfilling the cosmetic definition are regulated as cosmetics instead.

EFDA regulates standalone software and artificial intelligence based software as medical devices. Software as a Medical Device (SaMD) is defined as software intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device, and EFDA states that SaMD is a medical device and includes in vitro diagnostic medical devices. The scope of the guideline is all SaMD falling under the device or IVD definition irrespective of software technology or platform, and all medical devices incorporating artificial intelligence. It excludes software used in healthcare for non medical purposes such as administrative or financial software, software used to make or maintain a device, software that are accessories to hardware devices unless they meet the SaMD definition, and software integral to the functioning of a hardware device.

Ethiopian law defines a medical device as any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article and its accessories which does not achieve its primary intended action by pharmacological, immunological or metabolic means in or on the human body and is intended by the manufacturer to be used, alone or in combination, for a medical purpose, including devices for related medical use and for control of contraception. An in vitro medical device is defined separately as a device intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes, and expressly includes reagents, calibrators, control materials, specimen receptacles, software or related other articles. Software is named in both definitions, and accessories are within the device definition.

IVDR Art. 2(2): an 'in vitro diagnostic medical device' is any medical device that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, solely or principally to provide information (e.g. on physiological or pathological process or state, congenital impairment, predisposition, safety and compatibility).

MDR Art. 2(1): a 'medical device' is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for specified medical purposes (diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; injury/disability; investigation, replacement or modification of anatomy or a physiological process; control of conception; etc.).

Software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes of the device definition, qualifies as a medical device; general purpose software, even in healthcare settings, and lifestyle/well being software are not medical devices (MDR recital 19).

The national act's device rules apply also to accessories and, unless the MDR provides otherwise, to Annex XVI products within MDR scope; key operator/user provisions also apply to AIMDD/MDD compliant devices regardless of when they were placed on the market.

Reprocessing and reuse of single use devices is prohibited in Finland — stricter than MDR Art. 17, which allows Member States to permit reprocessing under conditions.

CSP Art. L5211 1 defines dispositif médical and accessoire de dispositif médical in line with the MDR; software (logiciel) is expressly listed among device categories, Annex XVI products without medical purpose are covered, and devices for conception control or assistance plus products specifically intended for cleaning, disinfecting or sterilising devices are deemed medical devices.

The device clinical investigation technical regulation defines a medical device as any instrument, apparatus, appliance, computer program (software), implant, reagent, material or other product intended by the manufacturer for human use, alone or in combination, for one or more of: (a) diagnosis, prevention, monitoring, prediction, treatment or alleviation of disease; (b) diagnosis, monitoring, treatment, alleviation or compensation of injury or disability; (c) investigation, replacement or modification of anatomical, physiological or pathological processes or states; (d) provision of information by in vitro examination of samples derived from the human body, including organ, blood and tissue donation, whose principal intended action is not achieved by pharmacological, immunological or metabolic means but which may assist such means; (e) devices for contraception or its promotion; (f) products specifically intended for cleaning, disinfecting or sterilising devices.

Georgian law defines 'medical goods' — medical goods used in medical practice for disease prevention, diagnostics, treatment and patient care such as instruments, devices, appliances, medical equipment, dressing material, prosthetic and orthopaedic products — as a category distinct from 'pharmaceutical product', which is a medicine or physiologically active substance whose effect on the human body results from pharmacological, immunological or metabolic action. The state regulation mechanisms of the Law on Medicines are attached to pharmaceutical products and to voluntarily registered complementary products; non invasive contraceptive mechanical devices are expressly exempt from the state regulation provided for by that Law.

On application of a competent authority, the manufacturer, its authorised representative or its notified body, the competent federal higher authority (BfArM) determines (entscheidet) the legal status of an individual product as a medical device or as an accessory to a medical device, or as an MDR Annex XVI product.

In vitro diagnostic medical device: a device intended by the manufacturer for in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes, including reagents, calibrators, control materials, specimen receptacles, software and instruments.

Medical device means an instrument, apparatus, implement, medical equipment, machine, contrivance, implant, in vitro reagent or similar article, including components and accessories, intended for diagnosis/cure/mitigation/treatment/prevention of disease or to affect body structure/function, not achieving principal intended purpose through chemical action or metabolism.

SaMD is software intended to be used for one or more medical purposes that performs those purposes without being part of a hardware medical device; it is a medical device and includes IVD software. Software intended to drive a hardware medical device is not SaMD. Mobile apps meeting the definition are SaMD.

By EOF Presidential Decision 91092/01 09 2023, skin applied products with health claims (muscle/joint pain etc.) containing camphor and/or menthol may not be placed on the Greek market as medical devices, because their mode of action is pharmacological (menthol/camphor act on cold receptors TRPM8/TRPV1/TRPV3); economic operators were given an adaptation period until 31/12/2024.

NT 37 defines a medical device as any instrument, apparatus or other similar or related article, used alone or in combination, including its components, parts and accessories that take part in its correct application, proposed by the manufacturer for diagnosis, prevention, monitoring, treatment or alleviation of disease or injury; investigation, replacement, modification or support of anatomical structure or physiological process; diagnosis of pregnancy and control of conception; and care during pregnancy, birth or afterwards including care of the newborn. A product that achieves its purpose through chemical action in or on the body, or that is biotransformed during use, is a medicine and not a device; a device to which pharmacological properties are attributed by reason of its composition must be registered as a medicine. Absorbable sutures that biodegrade are nonetheless included within devices.

NT 40 defines an in vitro diagnostic reagent as a reactive product or calibrator, used alone or in association with others, intended for the study of samples from the human body, including donations of blood, organs and tissues, principally to provide information on a physiological or pathological state, a congenital anomaly, the determination of the safety and compatibility of potential recipients, or the monitoring of therapeutic measures. IVDs are classified by health risk into Category I (low), Category II (medium) and Category III (high).

An accessory to a medical device is subject to the same regulations that apply to the medical device itself; devices for animals are outside scope.

The MDACS definition of medical device expressly includes software and reagents for in vitro use; IVD medical devices are separately defined (GN 00 clause 2.29).

Refurbished medical devices (3.2.1.10) and custom made medical devices (3.2.1.11) are outside MDACS scope; devices for non clinical purposes such as Research Use Only are also excluded (3.2.1.12).

MDACS covers software embedded in medical devices (SiMD) and standalone software as a medical device (SaMD) per TR 007, and artificial intelligence medical devices (AI MD) per TR 008.

Hungary maintains a national product category of medical aids (gyógyászati segédeszköz), including aids that are not medical devices; for non device medical aids the classification pointer is 14/2007 EüM rendelet 2. § (4) h).

Nursing technical devices (ápolási technikai eszköz) within the meaning of 4/2009. (III. 17.) EüM rendelet 17. § (7) fall under the national distributor notification duty even though they are not medical devices under the MDR.

Iceland's Act applies to medical devices as defined by the Regulations, and Article 3 of the Act extends the scope to the products without an intended medical purpose listed in Annex XVI of the MDR. Lyfjastofnun's own guidance gives the Annex XVI examples as non corrective contact lenses, substances or items intended for filling under the skin or mucous membrane, and equipment intended to reduce or remove adipose tissue.

Since 1 April 2020 every device instrument, apparatus, appliance, implant, material or other article, used alone or in combination, including software or an accessory, not achieving its primary intended action by pharmacological, immunological or metabolic means is regulated as a drug for the listed purposes (diagnosis/prevention/monitoring/treatment/alleviation of disease or disorder; injury or disability; investigation/replacement/modification/support of anatomy or physiological process; supporting or sustaining life; disinfection of medical devices; control of conception).

Medical devices are regulated as 'drugs' under s.3(b)(iv) of the Drugs and Cosmetics Act, 1940: devices intended for internal or external use in diagnosis, treatment, mitigation or prevention of disease become drugs when notified by the Central Government in the Official Gazette.

Alat Kesehatan (medical device) is defined as any instrument, apparatus, machine, equipment, implant, in vitro reagent and calibrator, software, or similar material used on humans for medical purposes whose principal action is not achieved by pharmacological, immunological or metabolic means. IVDs (in vitro reagents and calibrators) and software are inside this single definition; the former separate 'Alat Kesehatan Diagnostik In Vitro' category of PMK 62/2017 no longer appears as a distinct licence category in PMK 5/2026. PKRT (household health supplies) is a separate defined category.

Laboratory items whose declared field of use is 'research only' are NOT medical devices under Article 1 note (چ) of the medical equipment regulation and need no license from the Medical Equipment Directorate, provided the label and brochure clearly state 'فقط برای مصارف پژوهشی و تحقیقاتی' or 'Research Use Only'.

The MOP standard bidding document for medical equipment defines 'Registration Certificate' as the certificate of registration (or other documents in lieu) establishing that the medical appliances supplied under the contract are registered for use in Iraq in accordance with the Applicable Law; 'medical appliances' is a tender defined term for the equipment listed in the Schedule of Requirements.

For Irish national IVD registration, 'device' means an in vitro diagnostic medical device or IVD accessory and expressly excludes in house devices and products excluded by IVDR Article 1(3); health institutions manufacturing and using in house IVDs are notified separately under reg. 4.

Laboratory equipment (IVD, ציוד מעבדתי) is regulated by AMAR under the same rules as medical equipment at the corresponding risk classes (Europe defines 4 risk classes for medical and laboratory equipment; FDA defines 3).

The national decree adopts the MDR Art. 2 definitions and adds one national definition: 'reclamo' (complaint) — a written, electronic or oral communication declaring deficiencies related to identity, quality, durability, reliability, usability, safety or performance of a medical device, or a service affecting such devices' performance.

A medical device (医療機器) is a machine, instrument or similar article intended for diagnosis, treatment or prevention of disease in humans or animals, or to affect body structure or function, designated by Cabinet Order; regenerative medicinal products are excluded.

IVDs are regulated as 体外診断用医薬品 (in vitro diagnostic drugs): drugs used solely for disease diagnosis that are not applied directly to the human or animal body. Their approval, MAH licensing, manufacturer registration and postmarket rules follow the medical device chapter of the PMD Act (e.g., Arts. 23 2, 23 2 3, 23 2 4, 23 2 5).

Software that is a medical device (医療機器プログラム) is explicitly in scope: providing it over telecommunication lines constitutes marketing (製造販売) and is regulated like any other device marketing.

Purposes of a medical supply include: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis/monitoring of injury or handicap or compensation for them; detection, compensation for or modification of the anatomical structure; regulation of pregnancy; sterilization of medical and surgical devices; and providing information for a medical purpose via in vitro examination of specimens taken from the human body.

A medical supply is any material, means, device, instrument or laboratory reagent used alone or in combination with other items, including software necessary for its use and approved by the manufacturer, intended for humans for the listed purposes, without a pharmacological, immunological or metabolic effect on the human body.

Circulation (التداول) under Law 12/2013 covers transport, possession, distribution, offering for sale, gifting, donation, purchase, import, introduction and use.

«Medical devices» (медицинские изделия) are defined in the Health Code as products of medical purpose and medical equipment (изделия медицинского назначения и медицинская техника).

Software is a medical device if it: is a computer program or its modules regardless of platform or distribution method; is not a component of another medical device; is intended by the manufacturer for provision of medical care; and its action consists of automated interpretation (including AI) of data received from lawfully circulated medical devices, or per parameters set by a medical worker affecting clinical decisions.

A medical device containing a medicinal substance in its composition or as a constituent part is registered as a medical device on condition that it is registered as a medical device in the manufacturer's country.

Not subject to state registration: devices made to individual patient orders exclusively for personal use; devices produced in RK only for export; exhibition samples without right of sale; samples for (pre)clinical research or registration expertise; laboratory instruments not used for disease diagnostics; components that are part of devices and not used standalone; bulk products.

State registration covers devices produced in Kazakhstan or imported, including IVDs (in vitro), consumables for devices (except those specifically intended by the device manufacturer for use only with a given device), and devices included in specialized medical assistance vehicles.

An in vitro diagnostics medical device is defined in the 2022 Registration Rules as a device intended by the manufacturer for the in vitro examination of specimens derived from the human body.

PPB has issued a Guideline on Regulation of Medical Device Software in Kenya (MDSW) covering Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), with risk classification harmonized with IMDRF and WHO frameworks and covering cybersecurity, data protection, AI/ML considerations and lifecycle oversight from approval to post market monitoring.

Kenya applies a GHTF style definition: a medical device is any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for humans for diagnosis, prevention, monitoring, treatment or alleviation of disease, and other listed medical purposes.

statement: Latvian law contains no autonomous medical device definition: Article 1 point 21 of the Medical Treatment Law defines a medical device as any instrument, apparatus, appliance, software, implant, reagent, material or other article that meets the definition in Article 2(1) of Regulation (EU) 2017/745. Cabinet Regulation No. 461 paragraph 5 repeats that reference and extends the national rules to accessories and products covered by Article 1(4) of the Regulation. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: No · targetDecisionRetained: Yes

Under the general provisions, accessories of medical devices are treated as medical devices in their own right and must also satisfy all provisions of the national procedure.

The 2013 national procedure defines an active implantable medical device as any device designed to be totally or partially implanted in the human body or placed in a natural orifice and which depends for its functioning on an electrical or other energy source other than that generated directly by the human body or gravity, and a device accessory as any article intended principally by its manufacturer to be used with a medical device.

The procedure states that medical devices are organised in five large families: (1) active implantable medical devices, e.g. pacemakers; (2) in vitro diagnostic medical devices, e.g. trisomy tests; (3) custom made devices, e.g. dental prostheses; (4) devices intended to compensate a disability, e.g. hearing aids; and (5) all other devices, subdivided into non active implants, equipment (MRI, scanner, ventilators), consumables and device accessories, the latter being treated as devices. It also notes the spread of combined devices incorporating a medicinal substance, such as drug eluting coronary stents.

Liechtenstein defines device terms by direct reference: the definitions of EEA Agreement Annex II Chapters X and XXX, in particular Regulation (EU) 2017/745 (and Regulation (EU) 2017/746 for IVDs), plus Art. 2 of the Gesetz über die Verkehrsfähigkeit von Waren apply. No separate national definition catalogue exists in the EWR MepV/EWR IvDV.

Article 2 of the Health System Law defines device terms by direct reference to Regulation (EU) 2017/745 (e.g. 'incident', 'notified body'), so the MDR/IVDR definitions govern nationally with no divergent national device definition.

A medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more specified medical purposes (diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability; investigation, replacement or modification of the anatomy or of a physiological or pathological process; or providing information by means of in vitro examination of specimens derived from the human body), and which does not achieve its principal intended action by pharmacological, immunological or metabolic means. Software intended for medical purposes is itself a device.

Medical device means instruments, apparatus, implements, in vitro diagnostic reagents and calibrators, materials and other similar or related articles used directly or indirectly on the human body, including computer software; custom made devices for specific patients are a defined subcategory.

Medical device (peranti perubatan) covers any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or similar article intended by the manufacturer for human use for diagnosis, prevention, monitoring, treatment or alleviation of disease, injury compensation, anatomical/physiological support, life support, contraception, device disinfection, or in vitro examination of specimens, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means. Software and IVD reagents/calibrators are expressly included.

The Minister may, by gazette order and taking into account public safety, health or risk issues, declare any article used on the human body to be a medical device, and may determine 'prescribed/designated medical devices' subject to a separate permit regime.

Maltese law does not define a medical device independently. S.L. 458.59 reg. 2 provides that 'medical device' means any medical device as defined in Article 2(1) of Regulation (EU) 2017/745 and any in vitro diagnostic medical device as defined in Article 2(2) of Regulation (EU) 2017/746, and includes any product designated as such by the competent authority. The competent authority therefore retains a national power to designate a product as a device in addition to the Union definition. The regulations carry no separate device classification schedule, no national borderline product list and no national scope annex.

LGS Art. 262 defines dispositivos médicos through seven categories: (I) equipo médico; (II) prótesis, órtesis y ayudas funcionales; (III) agentes de diagnóstico; (IV) insumos de uso odontológico; (V) materiales quirúrgicos y de curación; (VI) productos higiénicos; (VII) any other inputs evaluated and recognized as medical devices.

IVD products are regulated as 'agentes de diagnóstico', a medical device category covering antigens, antibodies, calibrators, verifiers, reagents, reagent kits, culture and contrast media and any similar input used as an adjunct to clinical or paraclinical procedures.

COFEPRIS device registration guidance covers medical software (Software como Dispositivo Médico, ScDM): applicants must demonstrate safety and efficacy for ScDM within the device registration dossier.

Under Legea nr. 102 din 09 iunie 2017 a medical device is characterised as an instrument, apparatus, equipment, material or other article, used alone or in combination, including software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for the proper functioning of the medical device, intended by the manufacturer to be used for a human being for: diagnosis, prevention, monitoring, treatment or alleviation of a disease; diagnosis, prevention, monitoring, treatment, alleviation or compensation of an injury or disability; investigation, replacement or modification of the anatomy or of a physiological process; or control of conception and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but whose functioning may be assisted by such means.

The Law applies to relations concerning human medicines, medical devices and health supplementary products, and expressly does not apply to relations concerning veterinary medicines and devices, disinfection and sterilisation preparations, and feed supplements. "Medical device" is defined by intended purpose (prevention, diagnosis, treatment, monitoring of disease; supporting, replacing, restoring or rehabilitating bodily function; sterilising or disinfecting medical devices), with three enumerated sub categories: laboratory diagnostic devices (IVDs) using samples taken from the human or animal body, medical equipment requiring the professional activity of a medical equipment engineer or technician, and medical consumables that are single use or reusable.

statement: The Law on Medical Devices does not apply to medicines; cosmetic products; human blood, blood products, plasma or blood cells of human origin, or products containing them at the time of placing on the market, other than the products covered by Art. 2(4); transplants, tissues or cells of human origin and products containing or derived from them, other than the products covered by Art. 2(4); or transplants, tissues or cells of animal origin, unless the medical device is manufactured or made from non viable animal tissue or from a product made from non viable animal tissue. Its provisions do apply to in vitro diagnostic medical devices made of tissues, cells or other substances of human origin, and to accessories of medical devices. · exclusions: medicines; cosmetic products; human blood and blood products; human transplants, tissues and cells; animal transplants, tissues and cells (unless the device is made of non living animal tissue)

A medical device is any instrument, apparatus, equipment, material, product or other article used alone or in combination, including accessories and software involved in its operation, intended by the manufacturer to be used in humans for medical or surgical purposes, and whose principal intended action is not obtained by pharmacological, immunological or metabolic means, although its function may be assisted by such means. Active implantable devices and accessories are separately defined; products that form an integral, non reusable unit with a medicine are medicines, not devices.

'Medical Device' means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material or other similar or related article intended by the product owner for human use for diagnosis, prevention, monitoring, treatment or alleviation of disease, and related listed purposes, which does not achieve its primary intended action by pharmacological, immunological or metabolic means.

A medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more specified medical purposes (diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability; investigation, replacement or modification of the anatomy or of a physiological or pathological process; or providing information by means of in vitro examination of specimens derived from the human body), and which does not achieve its principal intended action by pharmacological, immunological or metabolic means. Software intended for medical purposes is itself a device.

IVDs are categorised as medical devices under the Medicines Act 1981, but are currently exempt from mandatory notification to the WAND database; they may be voluntarily notified, and suppliers are expected to notify Medsafe of safety issues or corrective actions.

A medical device is any device, instrument, apparatus, appliance or other article intended to be used in, on, or for human beings for a therapeutic purpose, that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means (though it may be assisted in its function by such means) — Medicines Act 1981 s 3A; the Database Regulations apply the same meaning.

Therapeutic purpose (Medicines Act 1981 s 4) includes preventing, diagnosing, monitoring, alleviating, treating or curing any disease or ailment, investigating or modifying physiological processes, testing susceptibility to disease, contraception, and pregnancy testing; claiming a therapeutic purpose for a product defines it as a therapeutic product subject to the Act.

Nigeria applies the IMDRF/GHTF definitions: the guidelines are built on GHTF/SG1/N71:2012 'Definition of the Terms Medical Device and In Vitro Diagnostic Medical Device'; separate classification and conformity assessment documents exist for IVD vs non IVD devices.

SaMD is regulated as a medical device: 'software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device'; SaMD includes IVD medical devices and mobile apps meeting the definition; software driving a hardware device is not SaMD.

The definitions of a medical device and of an in vitro diagnostic medical device in North Macedonia are statutory, not merely guidance: Член 2 of the Закон за лековите и медицинските средства ('Одделни поими употребени во овој закон го имаат следново значење:') carries 64 numbered definitions, and точка 49 defines 'Медицинско средство' as any instrument, apparatus, appliance, material or other product used in human medicine which has no pharmacological, immunological or metabolic action and is used alone or in combination, including the software necessary for its correct use, for diagnosis, prevention, monitoring, treatment or alleviation of disease; for diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; for investigation, replacement or modification of an anatomical or physiological process; and for control of conception. The same point adds that medical devices also include materials intended by their manufacturers to be used together with the device to enable its use, materials with specifically designed characteristics made to the written prescription of a qualified person for the individual use of a particular patient (custom made devices), and materials intended for clinical investigations. Точка 50 defines 'Медицинско средство за in vitro дијагностика' as a medical device comprising reagents, reagent products, reagent kits, control and calibration materials, instruments and apparatus, equipment or systems used alone or in combination and intended for use in in vitro conditions for the examination of biological samples, including tissue samples obtained from the human body, in order to provide information on the physiological or pathological state, on congenital anomalies, to determine compatibility with potential recipients, and to monitor therapeutic measures. The scope of the Law is set by Член 1, which covers medicines and medical devices for human use, the conditions and manner of securing their quality, safety and efficacy, their manufacture, testing, placing on the market, distribution, price formation, quality control, advertising and inspection — so advertising of devices is inside the statutory scope as well. MALMED's own guidance page reproduces the two definitions word for word, with one residue of the pre 2015 wording still visible ('употреба заедно со медицинското помагало'), which shows the page is a copy of the statutory text and not the source of it.

In cases of doubt, Direktoratet for medisinske produkter decides whether a product is to be regarded as a medical device (national rule; device definition itself follows MDR/IVDR Article 2 via the EEA Agreement).

IVD medical device means a medical device intended for in vitro examination of specimens derived from the human body, solely or principally to provide information on physiological/pathological states, congenital abnormality, predisposition, safety/compatibility, treatment prediction or monitoring; includes kits, reagents, calibrators, control materials, specimen receptacles, software and related instruments.

Oman adopts the GHTF/WHO style definition: any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar article intended by the manufacturer for specified medical purposes, not achieving its principal intended action by pharmacological, immunological or metabolic means.

Rule 12(1) directs the MDB to enlist and register medical devices defined as any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings or animals for diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury; or investigation, replacement, modification or support of the anatomy or of a physiological process.

In vitro diagnostic devices (reagents, calibrators, control materials, sample containers, software, instruments) are regulated devices. 'Productos afines a dispositivos médicos' (spare parts, accessories, consumables, health furniture, materials, supplies, health PPE and anything DNDM so designates) are also covered, as are remanufactured/recertified devices, combined devices, procedure kits, trays and prostheses.

'Dispositivo médico' means any instrument, apparatus, implement, machine, implant, in vitro reagent, software, material or other similar or related article intended by the manufacturer for use in humans for medical purposes (diagnosis, prevention, control, treatment or relief of disease, etc.), not achieving its principal intended action by pharmacological, immunological or metabolic means.

A medical device is any instrument, apparatus, equipment, implant, software, material or other article intended by the manufacturer to be used, alone or in combination, in human beings for the specified medical purposes listed in the resolution, whose principal intended action in or on the human body is not achieved by pharmacological, immunological or metabolic means, although such means may contribute to its intended action. The listed purposes open with diagnosis, prevention, monitoring, treatment or alleviation of disease.

An in vitro diagnostic product is a reagent, calibrator, control material, specimen receptacle, software, instrument, apparatus or other article, used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body, solely or principally, to provide information for diagnostic, aid to diagnosis, detection, monitoring, predisposition, prognosis, prediction, determination of physiological state or compatibility purposes.

A medical device is any instrument, apparatus, implement, machine, reagent or in vitro calibrator, software application, material or other similar or related article intended by the manufacturer for use in humans, alone or in combination, for diagnosis, prevention, monitoring, treatment or alleviation of disease, injury compensation, anatomical/physiological support, life support, conception control, or disinfection of medical devices.

In vitro diagnostic devices remain governed by the Reglamento approved by D.S. 010 97 SA under the Primera Disposición Complementaria Transitoria of D.S. 001 2012 SA; per DIGEMID's official FAQ, IVD analyzer equipment (excluding reagent strips, cuvettes with reagents and IVD reagents) is currently not subject to Registro Sanitario.

Standalone software meeting the medical device definition is considered an active medical device; software driving or influencing another device is classified by the intended use of the combination, and independent software per GHTF recommendations.

DIGEMID states current regulations do not contemplate authorization of used and/or repowered biomedical equipment, and it does not authorize import, marketing or use of such equipment in that condition.

Medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material or similar article intended by the manufacturer for diagnosis, prevention, monitoring, treatment or alleviation of disease etc., not achieving its principal intended action by pharmacological, immunological or metabolic means.

AO 2018 0002 does not cover in vitro diagnostic and refurbished medical devices; separate Administrative Orders were to be issued for them. In practice IVDs are handled through a separate 'CPR for IVD Devices/Reagents' service of CDRRHR.

Beyond implementing MDR/IVDR, the Act governs the use and maintenance of devices (including MDR Annex XVI products and IVDR Art. 1(2) products), clinical investigation and performance study inspections, and advertising of devices and its supervision; it also imposes duties on health institutions, medical professionals and other users.

Devices manufactured and used in house by health institutions under MDR Art. 5(5) must be notified to INFARMED electronically, with a declaration of GSPR compliance, exclusive internal use, QMS, updated technical documentation and justification that no equivalent CE marked device meets the target patients' needs.

Qatar's Law No. 6 of 2025 on the regulation of health research defines a 'medical product' (المنتج الطبي) as any device, medicine, biological product or other thing used to diagnose, prevent or treat diseases, and its definition of 'clinical trials' (التجارب السريرية) expressly names medical devices (الأجهزة الطبية) among the interventions a trial may evaluate, alongside medicines, experimental gene and stem cell therapy, behavioural therapies, and changes to the care process and preventive care.

Any diagnostic or treatment activity using equipment for in vitro examination of specimens, including via information society services, is deemed performed for a medical purpose and only IVD medical devices may be used.

Any form of health state evaluation or therapy, even if the values obtained are informative, including in complementary medicine or bioresonance cabinets, is deemed performed for a medical purpose and only medical devices may be used for it.

Reprocessing of single use devices and materials for reuse in public and private health institutions is prohibited, and use of reprocessed single use devices in such institutions is prohibited.

The national registration application must state whether the device can or cannot be classified as an in vitro diagnostics (IVD) device.

Medical devices are any instruments, apparatus, devices, equipment, materials and other items used for medical purposes separately or in combination with each other and with accessories, including special software, intended by the manufacturer for prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the human body, medical research, restoration, replacement or modification of anatomical structures or physiological functions, contraception, whose intended function is not realized through pharmacological, immunological, genetic or metabolic action on the human body.

The registration regulations apply to all regulated human and veterinary medical devices including in vitro diagnostics submitted for marketing authorisation, and they cover the full device groupings used by the Authority (single device, in vitro diagnostic, medical device group, medical device family, medical device group family and medical device system). All applications and supporting documents must be submitted in English, French or Kinyarwanda; where documents are in another language the applicant must submit translated copies to expedite review.

Broad MDR style definition covering instruments, apparatus, applied and implant devices, IVD reagents/calibrators, software and materials for operating medical devices, for diagnosis, prevention, monitoring, treatment or alleviation of disease etc., not achieving primary intended action by pharmacological/immunological/metabolic means. 'Medical Supplies' (including medical gases) and accessories are also within the Law's scope.

Software falls within the medical device definition; SFDA's digital health guidance applies it to SaMD and digital health categories (mHealth, digital therapeutics, health IT, telemedicine, wearables, VR/AR, AI/ML, general wellness). Software subject to the Law is classified by the intended purpose of the device it influences, or on a standalone basis by the classification rules.

Décret n° 2023 2419 is the national instrument that defines the regulated object. Article 1 fixes its scope: manufacture, registration, import, export and distribution of medical devices. Article 2 defines 'dispositif médical' by the manufacturer's intended purpose, with four limbs (diagnosis/prevention/monitoring/treatment/alleviation of disease; diagnosis/monitoring/treatment/alleviation/compensation of an injury or handicap; study, replacement or modification of anatomy or of a physiological process; control of conception), expressly including the software necessary for the device to function and expressly requiring that the principal intended action is not obtained by pharmacological, immunological or metabolic means while allowing the function to be assisted by such means. Two further categories are 'également réputés être des dispositifs médicaux' (also deemed medical devices): devices for the control of conception or assistance thereto, and products specifically intended for cleaning, disinfecting or sterilising devices. The same article defines 'accessoire d'un dispositif médical', 'dispositif médical de diagnostic in vitro', 'dispositif médical actif', 'dispositif médical implantable', 'dispositif médical invasif', 'dispositif médical à usage unique', 'dispositif médical destiné à des autodiagnostics', 'dispositif sur mesure', 'cycle de vie' (from initial design to decommissioning and disposal) and 'destination'. It also defines the negative categories 'dispositif médical de qualité inférieure', 'dispositif médical falsifié', 'dispositif médical non enregistré/non homologué' and 'marché illicite de dispositifs médicaux'.

An in vitro diagnostic medical device is any reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system intended for in vitro examination of samples to provide information on physiological/pathological states, congenital anomalies, predisposition, compatibility, treatment response prediction or monitoring; sample receptacles are IVDs. An accessory is a product that is not a medical device but is specifically intended by the manufacturer to be used in combination with one; invasive sampling devices are general devices, not IVDs. ALIMS determines product status (whether a product is a medical device) on prescribed criteria.

A general medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other product used alone or in combination, including software provided by the manufacturer for diagnostic or therapeutic purposes, intended for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, injury/disability compensation, anatomy/physiology modification, in vitro examination information, conception control, or cleaning/disinfection/sterilisation of devices, whose principal intended action is not pharmacological, immunological or metabolic. Accessories are covered by the law.

A 'medical device' means a medical device referred to in the First Schedule to the Health Products Act; in vitro diagnostic products are separately defined in reg 2 of the Medical Devices Regulations 2010.

A medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more specified medical purposes (diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability; investigation, replacement or modification of the anatomy or of a physiological or pathological process; or providing information by means of in vitro examination of specimens derived from the human body), and which does not achieve its principal intended action by pharmacological, immunological or metabolic means. Software intended for medical purposes is itself a device.

Health institutions manufacturing in house devices must publish an 'Izjava o proizvodnji in uporabi internih pripomočkov' on their website; the documentation duty of Art. 5(5)(g) extends beyond class D also to in house class B and C devices; units producing in house IVDs must meet at least SIST EN ISO 15189; JAZMP may demand documentation to verify conformity.

Reprocessing of single use devices is allowed only within the same health institution, or by an external processor seated in Slovenia that returns the fully reprocessed device to that institution; the device must be on the JAZMP list of devices permitted for reprocessing; the institution bears manufacturer type obligations; reprocessed single use devices may not be placed on the market.

Under Regulation 1 of GN R1515/2016, an IVD ('in vitro diagnostic') means a medical device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes.

Under section 1 of Act 101/1965, a 'medical device' is any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article (including Group III and IV Hazardous Substances under Act 15/1973), intended by the manufacturer for diagnosis, prevention, monitoring, treatment or alleviation of disease, and related purposes, which does not achieve its primary intended action by pharmacological, immunological or metabolic means (but may be assisted by such means).

A 'research use only IVD' (RUO IVD) is defined as an IVD labelled for 'research use only' and 'investigational use only' and may not be used for clinical diagnostic purposes; combination devices (device incorporating a medicine as an integral part with ancillary action) and custom made devices are separately defined with their own rules.

A medical device (의료기기) is any instrument, machine, apparatus, material or software or similar product used alone or in combination on humans or animals for diagnosis, treatment, alleviation, treatment or prevention of disease (among other listed purposes).

AEMPS decides on the application to a product of the definitions and classification criteria of Regulation (EU) 2017/745 (Articles 2 and 51.2 and Annex VIII), and may consult the Comité de Productos Sanitarios.

An IVD medical device means a device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes, including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus.

Listed devices do not fall under the statutory definition of a medical device; they are characterised by a lack of direct physiological or clinical impact, pose the lowest risk and do not fall into clinical classes I, IIa, IIb or III; NMRA nevertheless registers them under the low risk route (GL 034: products not falling within the definition of medical devices but used for personal hygiene or general medical purposes).

Per the NMRA Act as published by NMRA, a medical device is any instrument, apparatus, appliance, software, material or other article, used alone or in combination including software necessary for its proper application, intended by the manufacturer for use in or on human beings for diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; investigation, replacement or modification of the anatomy or of a physiological process; or control of conception; and which does not achieve its intended action by pharmacological, immunological or metabolic means. Ayurveda devices and Homeopathy devices are excluded.

Sweden regulates a national product category 'nationella medicinska informationssystem' (NMI, national medical information systems) — products that in terms of use are close to medical devices — under HSLF FS 2022:42; NMI manufacturers must register with Läkemedelsverket, pay fees, and report incidents and FSCA in the same way as CE marked devices under MDR.

An IVD is a medical device under Art. 3(1) (2) MedDO that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, device, software or system, intended by the manufacturer for in vitro examination of specimens derived from the human body.

Medical devices are instruments, apparatus, equipment, software, implants, reagents, materials or other articles intended by the manufacturer for use in humans whose principal intended action in or on the human body is not achieved by pharmacological, immunological or metabolic means (the mechanism of action may be assisted by such means).

Medical device means instruments, apparatus, appliances, materials, software, in vitro diagnostic reagents and related articles whose design and use act on the human body by means other than pharmacological, immunological, metabolic or chemical action, to achieve one of: diagnosing, treating, mitigating or directly preventing human disease; regulating or improving body structure or function; or regulating fertility.

Software (軟體) and in vitro diagnostic reagents (體外診斷試劑) are explicitly named within the statutory definition of medical device, so SaMD and IVDs fall under the same regime (no separate IVD statute).

Accessories are classified in their own right as medical devices and do not necessarily take the classification of the device with which they are intended to be used; a product is an accessory only if it has an established intended use in conjunction with a medical device.

IVD medical device: a device intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes, including reagents, calibrators, control materials, specimen receptacles, software and related instruments.

Cap. 219 defines 'medical device' broadly any instrument, apparatus, laboratory equipment and reagent, implement, machine, appliance, implant, in vitro reagent, or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings or other animals.

Standalone software (SaMD in IMDRF context) is regulated: a software and/or mobile application intended to function by itself and not intended to control or affect the operation of other hardware medical devices; the compendium has a dedicated software guideline (Part X).

The compendium addresses borderline determination: where a product has features similar to medicines, cosmetics, food supplements or biocides, device status may be difficult to determine and is assessed case by case (dedicated borderline manual, Part XI).

Medical gases (e.g. oxygen, nitrous oxide, medical air, carbon dioxide, helium) are regulated as medical devices through the notification route; applications must include controlled copies of valid SOPs/protocols for production including storage procedures.

Used products refurbished by a third party that is not the original manufacturer: that third party bears the responsibility of the manufacturer under the guideline.

A medical device (เครื่องมือแพทย์) includes instruments, appliances, machines, objects inserted into the body, IVD reagents, products, software and other articles intended by the manufacturer/product owner for specified uses in humans or animals (diagnosis, prevention, monitoring, treatment, injury care, life support, etc.), and excludes articles whose principal action results from pharmacological, immunological or metabolic processes.

The ANMPS import technical control procedure applies to medical devices together with food supplements, cosmetic products and childcare articles, in a single instrument. ANMPS defines the procedure's object as the control of medical devices, cosmetic products and childcare articles within the framework of the technical control at importation, and the procedure is written as one document with separate branches for cosmetics and supplements on one side and medical devices and childcare articles on the other.

Devices manufactured and used within health institutions are exempt from the Regulation's requirements except the Annex I general safety and performance requirements, provided all Madde 5(5) conditions are met (no transfer to another legal entity; manufacture and use under appropriate quality management systems; further conditions listed in the article).

A medical device is defined (mirroring EU MDR) as an instrument whose principal intended function is not achieved by pharmacological, immunological or metabolic means, covering diagnosis, prevention, monitoring, treatment or alleviation of disease, etc.

A device supplied to a person via information society services is covered by the Regulation; providers must supply a copy of the EU declaration of conformity on request, and the Kurum may require the provider to cease activities for public health protection.

Uganda's device statute does not use the phrase 'medical device'. The regulated object is the 'surgical instrument', defined in reg. 24 of S.I. 2014 No. 29 as any instrument, apparatus, implement, machine, implant, in vitro reagent or calibrator, software, material or other similar or related article, and expressly including an appliance, intended by the manufacturer to be used alone or in combination, for human beings or animals for one or more of six listed purposes: diagnosis/prevention/monitoring/treatment/alleviation of disease; diagnosis/monitoring/treatment/alleviation of or compensation for an injury; investigation, replacement, modification or support of the anatomy or of a physiological process; supporting or sustaining life; disinfection of a surgical instrument; or providing information for medical purposes by in vitro examination of specimens — and which does not achieve its primary intended action by pharmacological, immunological or metabolic means. 'In vitro diagnostic device' and 'test kit' are defined separately in the same regulation. DAR/GDL/028 s. 1.3 confines the guideline to registration of surgical instruments and appliances in Uganda only, and excludes instruments and appliances used for a patent application or a donation/gift.

TR 754 covers IVDs and their accessories (reagents, calibrators, control materials, kits, instruments for examining human samples); it does not apply to devices manufactured and used only within a single healthcare institution or enterprise.

A medical device (виріб медичного призначення) is any instrument, apparatus, device, software, material or other article intended for diagnosis, treatment, prevention in the human body and/or support of those processes; software is explicitly within scope.

A device is regulated as 'Medical Equipment': a Medical Product that contains a substance, device, instrument, engine, implant, detector or system, including accessories and its operating software; it expressly includes wearable devices and AI based products, achieves its intended purpose without a pharmaceutical, immune or metabolic effect, and is used for diagnosis/treatment/prevention of disease, injury or disability, detection/modification/replacement of anatomical position, or birth control.

An in vitro diagnostic medical device is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system intended by the manufacturer for in vitro examination of human specimens to provide information on physiological or pathological states, congenital abnormality, safety/compatibility of donations, or therapeutic monitoring; specimen receptacles are included.

A medical device is any instrument, apparatus, appliance, software, material or other article (including accessories and diagnostic/therapeutic software) intended by the manufacturer for human use for diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or handicap, investigation/replacement/modification of anatomy or a physiological process, or control of conception, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means.

FD&C Act 201(h)(1) defines a device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory, that is intended for use in diagnosis of disease or other conditions, or in cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, and that does not achieve its primary intended purposes through chemical action within or on the body and is not dependent upon being metabolized.

In vitro reagents (IVDs) and radiation emitting products with medical claims are devices; software functions (including mobile medical apps) that meet the 201(h) definition are devices; software functions excluded pursuant to FD&C Act section 520(o) are not devices.

Art. 1 of Decreto 3/008 establishes three categories: A) reactivos para diagnóstico (chemical or biological substances, alone or as systems, excluding reading equipment, used in vitro or in vivo to investigate a human ailment); B) equipos médicos (instruments or apparatus, mechanical, electrical, electronic or logical including software applied to diagnostic, biological, imaging or therapeutic ends, including spare parts, calibration/conditioning solutions and accessories); C) dispositivos (terapéuticos/médicos) (instruments, implements, implants and materials for diagnosis, prevention, monitoring, treatment or alleviation of disease, etc., whose principal action is not achieved by pharmacological or metabolic means).

In vitro diagnostic devices («in vitro» ташхис тиббий жиҳозлари) are products used to examine, diagnose, monitor or establish compatibility of samples taken from the human body outside the organism, together with their consumables and components.

Medical devices (тиббий жиҳозлар) are instruments, apparatuses, equipment, devices, units and software permitted for use in medical practice for prevention, diagnosis, treatment, rehabilitation, monitoring or modification of body functions and contraception, which do NOT achieve their principal action by pharmacological, immunological or metabolic means.

Software intended for one or more medical purposes (diagnosis, monitoring, treatment, decision support) that performs its functions independently of a medical device — including platform software interoperating with other device or non device software and IVD software — is defined as a medical device.

An accessory is a product designated by the device owner for a specific purpose together with a specific medical device, to enable or support that device's use for its intended purpose.

'Product owner' (Chủ sở hữu thiết bị y tế) is the organization or individual that supplies the device under its own name/trade name and is responsible for design, manufacture, assembly, processing, packaging, repair, or determining the intended use.

statement: The Act defines a medical device to 'include an instrument, apparatus, component, part or accessory manufactured or sold for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or the symptoms of the disease, or abnormal physical state in human beings or animals'. The non IVD guideline uses a longer definition covering instruments, apparatus, implements, machines, appliances, implants, reagents for in vitro use, software and materials intended for diagnosis, prevention, monitoring, treatment or alleviation of disease, injury, investigation or support of anatomy or physiological process, supporting or sustaining life, control of conception, disinfection of medical devices and providing information by in vitro examination, provided the device does not achieve its primary intended action by pharmacological, immunological or metabolic means. The non IVD guideline's scope expressly covers non in vitro medical devices other than in vitro diagnostics, and its definition of 'non in vitro medical devices' excludes condoms and medical gloves, which are handled under separate ZAMRA instruments. The IVD guideline applies to in vitro diagnostic devices for human use, excluding in vitro diagnostics for veterinary use.

statement: The Condom Regulations define a 'condom' as 'a medical device which is intended to be worn on the penis during sexual activity for purposes of contraception and to prevent the spread of sexually transmitted infections'. A person may not sell any condom unless it is of a type and brand approved by the Authority, and the Authority may fix any conditions it considers necessary or desirable when approving a type and brand.

statement: The Gloves Regulations define a 'glove' as a medical glove for single use intended to protect the user from cross contamination; or a sterile, anatomically shaped surgical glove intended for invasive surgery; or an examination or procedure glove intended for medical examinations, diagnostic and therapeutic procedures and handling contaminated medical materials; or a seamed or welded medical glove; or any other glove determined by the Authority. The regulations apply to gloves used or intended for use for any medical purposes. A person may not sell any gloves unless the glove is of a type approved by the Authority.