Classification rules by country

In a conflict between the manufacturer and the approved (notified) body over application of the classification rules, the matter is referred to the minister responsible for health for decision.

Applicant self classification: the homologation dossier must state the classification of the device and the classification rules applied (arrêté 10 May 2021, Art. 4, same requirement in renewal and regularization dossiers); admissibility of export route files includes verification of the positioning and classification of the device.

axis: Classes I, IIa, IIb and III by order of criticality (décret exécutif 20 324). · classes: id: i · label: Class I · normalizedRiskLevel: low; id: iia · label: Class IIa · normalizedRiskLevel: medium; id: iib · label: Class IIb · normalizedRiskLevel: high; id: iii · label: Class III · normalizedRiskLevel: highest · regulator: MIPh (Ministère de l'Industrie Pharmaceutique) · notes: Art. 17 décret 20 324: Classe I faible / IIa modéré / IIb élevé / III critique; classification takes account of the evolution of international consensus; no local GHTF/MDR rule annex is referenced beyond the class labels.; The homologation dossier must state the device classification and the classification rules applied (arrêté 10 May 2021, Art. 4; same requirement in renewal and regularization dossiers).

Depending on the potential risk from their use, medical devices applied in Armenia, including those intended for in vitro diagnosis, are divided into classes in the procedure established by legislation (Art. 46(9)). The class drives the state duty amount for registration (10x / 20x / 30x base duty for classes 1 / 2 / 3 under Art. 16 point 35 of the Law on State Duty), the class 1 carve out from the manufacture and servicing licence requirements (Arts 47.1(1) and 47.4(1)), the class 1 declaration of conformity substitution in the import file (Decree 429 N para. 10.1), and the three yearly professional observation of manufacturers of risk class 2a (sterile), 2b and 3 devices (Art. 47.1(6)).

Clause 1.2.3 defines registered medical devices as those of higher, high and/or medium risk degree. The registration dossier includes the manufacturer’s quality management system certificate and a safety and effectiveness conformity declaration stating the risk degree. Sterilisation and bioburden test results and validation data are required for sterile medical devices.

Bahrain classifies medical devices into four risk classes class I low risk, class IIa low to medium risk, class IIb medium to high risk and class III high risk and IVDs into class A (low individual and low public health risk), B (moderate individual and/or low public health risk), C (high individual and/or moderate public health risk) and D (high individual and high public health risk). Classification criteria must be fulfilled before submitting a registration application, and NHRA may require a classification letter for borderline products.

statement: Bolivia classifies medical devices into four classes: Class I (low risk, general controls), Class IIa (moderate risk, special manufacturing controls), Class IIb (high risk, special design and manufacturing controls) and Class III (very high risk, special controls, intended to protect or sustain life or of substantial importance in preventing deterioration of health). The manual states that Bolivia recognises the classification rules of the GHTF (Global Harmonization Task Force), set out in the manual, and the classification is based on potential risks related to use and possible failure, combining duration of body contact, degree of invasiveness and local versus systemic effect. · article: Numeral 1.7 and numeral 1.7.2

Medical devices are classified by the degree of risk to the user into Class I (low risk), Class IIa (higher risk), Class IIb (high risk) and Class III (highest risk). Devices are additionally classified by their nature, energy coupling and other properties as non invasive, invasive and active. In vitro diagnostic medical devices are classified separately into List A and List B (for use by professionals only), devices for self diagnosis, and all other in vitro diagnostic devices.

BoMRA classifies general medical devices into four classes: Class A (low risk/hazard), Class B (low to moderate risk), Class C (moderate to high risk) and Class D (high risk). Classification is rule based, derived from the GHTF/IMDRF style rules, and where more than one rule applies the device is allocated the highest level of classification indicated.

IVDs are classified under their own four class system in Table 1 of BOMRA/ER/MED/P04/G06: Class A (low individual and low public health risk), Class B (moderate individual and/or low public health risk), Class C (high individual and/or moderate public health risk) and Class D (high individual and high public health risk), with classification driven by the device's intended use and the applicable IVD rules.

classes: III; IV · route: registration

For Dealer Type Approval, AITI categorises equipment into three levels by the risk that non compliance would cause interference to the radio frequency spectrum and telecommunications network: Level 1 low risk (example: short range devices), Level 2 moderate risk (example: marine radio) and Level 3 high risk or impact on personal safety (example: repeater station). A medical device is graded only if it is telecommunications or radio communications equipment.

Brunei has no medical device risk class axis. The only classification in the Medicines Act is the supply classification of medicinal products into general sale list products (s. 24), products sold only from a registered pharmacy under a pharmacist's supervision (s. 25) and prescription only products (s. 30); the Act and its regulations contain no class A to D, class I to IV or other device grading.

ISP's risk classification guide (2nd ed., June 2018) applies 22 classification rules (non invasive, invasive, active, additional) on IMDRF/GHTF principles; if several rules apply the highest class prevails (criterio 3.8); accessories are classified separately (3.9); software integral to equipment takes the equipment's class and standalone software is classified by its own rules (3.6); ISP may assign a different class based on historical market behavior (3.11); borderline devices take the higher class.

Class determines documentation/controls under D.S. 825/1998 Art. 21: Clase I — product/manufacturer/distributor identification, materials declaration, sterilization/storage data, background evidence of quality, performance evaluation per official norms, legalized export certificate for imports; Clase II — all of Clase I plus quality system manufacturing certificate NCh ISO 9002 or GMP; Clase III — Clase I plus supporting scientific literature, manufacturer safety/effectiveness studies, NCh ISO 9001 or GMP certificate; Clase IV — Clase III plus studies in representative patient groups, study of all inherent risks, and biological studies.

Application of the class based regime is progressive by product incorporation decrees: supreme decrees list the devices brought under control and their class (D.S. 825/1998 Art. 22); currently 10 DM/DMDIV types require registration, extended by Decreto Exento 25/2026 (39 categories).

axis: Risk classes I through IV for conformity verification purposes (D.S. 825/1998). · classes: id: i · label: Clase I · normalizedRiskLevel: low; id: ii · label: Clase II · normalizedRiskLevel: medium; id: iii · label: Clase III · normalizedRiskLevel: high; id: iv · label: Clase IV · normalizedRiskLevel: highest · regulator: ISP · notes: Art. 20 D.S. N°825/1998: devices are grouped into 4 classes by risk level associated with use (I very low, II moderate, III high potential, IV most critical).; ISP's risk classification guide (2nd ed., June 2018, ispch.cl) applies 22 classification rules (non invasive, invasive, active, additional) on IMDRF/GHTF principles; when several rules apply the highest class prevails (criterio 3.8); accessories are classified separately (3.9); software integral to equipment takes the equipment's class, standalone software by its own rules (3.6); ISP may assign a different class based on historical market behavior (3.11); borderline devices take the higher class.; Class scales documentation/controls under Art. 21 (Clase II adds quality system manufacturing certificate NCh ISO 9002 or GMP; Clase III adds scientific literature, safety/effectiveness studies, NCh ISO 9001; Clase IV adds studies in representative patient groups, inherent risk and biological studies).; Application is progressive via product incorporation decrees listing devices and their class (Art. 22); currently 10 DM/DMDIV types require registration, extended by Decreto Exento 25/2026 (39 categories).

The AIRP applies the UEMOA four class risk classification to medical devices — class A (I), class B (IIA), class C (IIB) and class D (III) — with a single parallel tariff column for in vitro diagnostic medical devices (DMDIV) headed « DMDIV de Classe D (III) ». The application letter must state the device's classification according to the classification retained by the UEMOA regulation, and the fee schedule is banded on these classes. A separate 10 000 CFA franc line covers the declaration of laboratory reagents for medical biology.

Classification itself follows MDR Annex VIII, but Croatia gives the Agency a national decision role in classification disputes: where a manufacturer and a notified body disagree on the application of the classification rules, the dispute is submitted to HALMED, which must adopt a decision within 30 days of receiving a complete request, extended by 15 days if it asks the applicant to supplement the documentation. No appeal lies against the decision; an administrative dispute may be initiated.

Cyprus applies the Union classification: medical devices fall into four classes — I, IIa, IIb and III — and in vitro diagnostic medical devices also fall into four classes — A, B, C and D. Specimen receptacles are also treated as in vitro diagnostic medical devices. CYMDA writes the device classes with Roman numerals (Ι, ΙΙα, ΙΙβ, ΙΙΙ) and the IVD classes with Greek letters (Α, Β, Γ, Δ).

Resolución 000004 16 lists three alternative criteria for a new registration or renewal to use the simplified procedure: (1) imported products previously authorised by a WHO stringent authority or a PAHO/Red PARF regional reference authority, evidenced by that authority's free sale and GMP certificates; (2) products of national manufacturers meeting the national GMP norms and the Red PARF harmonised GMP inspection guide; (3) products that DIGEMAPS has classified as low risk. Products with quality failures found in post marketing monitoring or serious safety reports are excluded.

Devices are divided into classes I, IIa, IIb and III taking into account the intended purpose and inherent risks, and classification is carried out in accordance with Annex VIII to Regulation (EU) 2017/745. Estonia sets no separate national classification of its own; the Medical Devices Act leaves classification to the directly applicable Union rules.

EFDA classifies non IVD medical devices into four risk classes, Class I (lowest risk) to Class IV (highest risk), and IVD medical devices into four classes A to D, using its classification guidelines (EFDA/GDL/041 for non IVD devices and a separate guideline for IVD classification). Classification is based on the risk associated with the device at the point of use and is determined from the manufacturer's intended purpose, the effectiveness of the applied risk management techniques, the intended users and the mode of operation. GDL/041 applies rule based classification for non invasive, invasive, active and special devices, with factors including duration of contact, degree and site of invasiveness, whether the device delivers medicines or energy, biological effect, local versus systemic effect, contact with injured skin, diagnosis versus treatment, reusability and combination with other devices. The class determines the assessment route: Class I non IVD and Class A IVD devices on the published low risk list use the abbreviated/notification route under GDL/092.

Medical devices are classified into classes I, IIa, IIb and III under Annex No. 1.1 to the device clinical investigation technical regulation, which reproduces the EU style rule set: active devices for administering or removing medicinal products, body liquids or other substances are IIa (IIb where the method is potentially hazardous); active devices for diagnostic or therapeutic radiology, including interventional radiology devices, are IIb; software providing information for diagnostic or therapeutic decisions is IIa, rising to IIb or III on the severity of the decision; devices for contraception or prevention of sexually transmitted disease are IIb, or III if implantable or long term invasive; devices incorporating a substance that would itself be a pharmaceutical product are III; devices of human or animal tissue origin are III; nanomaterial devices are III, IIb or IIa according to internal exposure potential. Clinical investigation of class IIa, IIb and III devices is registered only on a positive recommendation of the Coordination Council for Clinical Investigations of Medical Devices.

BfArM rules on the classification of individual products on application by a competent authority, the manufacturer, its authorised representative or its notified body; the authority should decide within three months ('soll innerhalb von drei Monaten ... entscheiden'). BfArM publishes an informal classification application route under § 6 Abs. 2 MPDG.

Where a device can be classified into more than one class, the higher risk class applies

Non IVD classification rules (Appendix IV Part 1, Rules 1 16, GHTF/CMDR style): surgically invasive devices default Class II; surgically invasive devices for central cardiovascular/central nervous system or fetus in utero are Class IV; absorbable or >=30 day implants Class III; body orifice devices >=30 days Class III; barrier contraceptives Class III; surgical/dental instruments Class I; latex condoms Class II; non invasive devices modifying blood/body fluids Class III (Class IV if hazardous foreign substance introduced); ionizing radiation active devices Class III (radiographic mode Class II; mammography Class III); closed loop therapeutic control Class IV; disinfecting/sterilizing devices for transfusion/transplantation tissues Class IV, for devices Class II; tissues/recombinant DNA devices Class IV; special table: breast implants and tissue expanders Class IV

IVD classification rules (Appendix IV Part 2, Rules 1 4): IVDs detecting transmissible agents in blood/tissues for transfusion or transplantation suitability are Class IV; transmissible agent IVDs default Class II, upgraded to Class IV for life threatening disease with propagation risk in the Ghanaian population and Class III for serious disease propagation risk, sexually transmitted agents, cerebrospinal fluid/blood infectious agents, or erroneous results risking death or severe disability; patient management IVDs default Class II, Class III for life threatening disease management or imminent life threatening decisions from erroneous results

SaMD is separately categorised into four categories (I IV) based on the level of impact on healthcare/patient identified in the SaMD definition statement, independent of the device class scheme; highest category applies when multiple statements fit

axis: Risk classes I through IV (FDA Ghana registration guidelines, GHTF/CMDR style rules). · classes: id: i · label: Class I · normalizedRiskLevel: low; id: ii · label: Class II · normalizedRiskLevel: medium; id: iii · label: Class III · normalizedRiskLevel: high; id: iv · label: Class IV · normalizedRiskLevel: highest · regulator: FDA Ghana · notes: Class I lowest risk to Class IV highest (Section 3.3.1 3.3.3); where a device can be classified into more than one class, the higher risk class applies (Section 3.3.2).; Appendix IV Part 1 Rules 1 16 (GHTF/CMDR style): surgically invasive devices default Class II; central cardiovascular/CNS or fetus in utero devices Class IV; absorbable or >=30 day implants Class III; surgical/dental instruments Class I; latex condoms Class II; blood/body fluid modifying devices Class III (IV if hazardous foreign substance); ionizing radiation active devices Class III (radiographic mode Class II); closed loop therapeutic control Class IV; transfusion/transplant tissue sterilizers Class IV; breast implants and tissue expanders Class IV.; Appendix IV Part 2 IVD Rules 1 4: transfusion/transplant transmissible agent screening Class IV; life threatening disease with Ghanaian population propagation risk Class IV; STD agents, cerebrospinal fluid/blood infectious agents, or erroneous results risking death/severe disability Class III; patient management IVDs default Class II, Class III for life threatening disease management.; SaMD is separately categorized into four categories (I IV) by level of impact on healthcare/patient, independent of the device class scheme (SaMD registration guideline, Section 4.3.1).

Devices are divided into risk classes I, IIa, IIb and III according to their intended purpose and risk, classified in accordance with Annex VIII of the Regulations. A disagreement between the manufacturer (or its authorised representative) and the notified body concerned on classification is referred to Lyfjastofnun under Chapter V of the Regulations.

By Minister of Health decree, after consulting the State Regions Conference, further branches of the national nomenclature may be determined to aggregate devices into homogeneous classes for National Health Service (SSN) needs, including device procurement.

Special national classification rules: devices containing a nanomaterial — class 3; apheresis devices incl. sets, connectors and solutions — class 3; polymer blood containers — class 2б; standalone software used with a device — same class as that device.

EAEU route: classification follows the EAEU Rules of classification of medical devices by potential risk of application approved by EEC Board Decision № 173 of 22.12.2015; Decision 46 requires the expertise to verify the class claimed by the applicant.

axis: Risk classes 1, 2a, 2b and 3 by degree of potential application risk (MoH Order No. ҚР ДСМ 281/2020). · classes: id: 1 · label: Class 1 · normalizedRiskLevel: low; id: 2a · label: Class 2a · normalizedRiskLevel: medium; id: 2b · label: Class 2b · normalizedRiskLevel: high; id: 3 · label: Class 3 · normalizedRiskLevel: highest · regulator: Ministry of Health · notes: Medical devices including IVDs divide into 4 classes (1 low, 2а medium, 2б elevated, 3 high); the applicant determines the class per the annexed method; the class is fixed at state registration and each device belongs to only one class (paras 8, 10, 35 36; Chapter 3 for IVDs).; Special national rules: devices containing a nanomaterial class 3 (para 30); apheresis devices incl. sets, connectors and solutions class 3 (para 29); polymer blood containers class 2б; standalone software used with a device takes that device's class (paras 31, 33).; EAEU route: classification per the EAEU Rules approved by EEC Board Decision No. 173 of 22.12.2015; expertise must verify the class claimed by the applicant (Decision No. 46, rules para 23 item б).

Classification is determined rule based by the manufacturer: categories are non invasive devices, invasive devices (body orifice / surgically invasive), active devices, and exceptional classes (devices incorporating medicinal substances, non viable animal tissues, sterilizers/disinfectants, ophthalmic solutions, contraception/STD prevention, long term implants); where a device falls into more than one class the highest applies, and the actual classification is determined by the manufacturer based on intended use

IVDs are classified into four classes A D: Class A (low individual and low public health risk, e.g. clinical chemistry analyser), Class B (moderate individual/low public health risk, e.g. pregnancy self testing, urine test strips), Class C (high individual/moderate public health risk, e.g. blood glucose self testing, PSA screening, rubella), Class D (high individual and high public health risk, e.g. HIV blood donor screening/diagnostic); classification criteria are intended use/indications, technical expertise of the intended user (lay vs professional), and importance of the information to diagnosis and public health impact

IVD classification rules: Rule 1 classifies IVDs intended for certain listed purposes as Class D (per Section 2.15.3, which sets out numbered rules assigning IVDs to Classes A D)

axis: Risk classes A through D for devices and IVDs (PPB registration guidelines). · classes: id: a · label: Class A · normalizedRiskLevel: low; id: b · label: Class B · normalizedRiskLevel: medium; id: c · label: Class C · normalizedRiskLevel: high; id: d · label: Class D · normalizedRiskLevel: highest · regulator: PPB · notes: Classification based on intended purpose, intended user, duration of contact, degree of invasiveness, delivery of medicinal products or energy, and biological effect (IMDRF style); where a device has features in more than one class, the highest class applies (Section 2.1, Table 1).; Rule categories: non invasive, invasive (body orifice / surgically invasive), active, and exceptional classes (devices incorporating medicinal substances, non viable animal tissues, sterilizers/disinfectants, ophthalmic solutions, contraception/STD prevention, long term implants); the actual classification is determined by the manufacturer based on intended use (Section 2.1.1).; IVDs: Class A low individual/low public risk (e.g. clinical chemistry analyser), B moderate/low (pregnancy self testing, urine strips), C high/moderate (blood glucose self testing, PSA screening, rubella), D high/high (HIV blood donor screening); criteria are intended use, technical expertise of the intended user (lay vs professional), and importance of the information to diagnosis and public health impact (Section 2.15.1, Table 8); numbered IVD classification rules in Section 2.15.3.

statement: Medical devices are divided into classes I, IIa, IIb and III according to their intended purpose and inherent risks, with classification carried out under Annex VIII of Regulation (EU) 2017/745. Latvian law applies those classes directly: the notification procedure is keyed to class IIa, IIb and III, and Latvian registration and vigilance fees are set by class. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: No · targetDecisionRetained: Yes

Decision No. 1506/1 of 1 September 2014, Article Three, classifies devices by level of risk according to a table mapped across the classification systems of the European Union, the United States, Japan, Australia, Switzerland and Canada: Low risk = EU I, US I, Japan I, Australia I, Swiss I, Canada I; Low To Moderate = EU II a, US II, Japan II, Australia I m/II a/Is, Swiss II a, Canada II; Moderate To High = EU II b, (no US entry), Japan III, Australia II b, Swiss II b, Canada III; High = EU III, US III, Japan IV, Australia III, Swiss III, Canada IV. Article Two classifies and codes devices under the globally adopted GMDN nomenclature; the November 2013 procedure assigns a unique national code to each device on the LNMDI list.

Luxembourg maintains no national classification scheme: the directly applicable EU MDR Art. 51 and Annex VIII classes (I, Is, Im, Ir, IIa, IIb, III) — and IVDR Art. 47 and Annex VIII for IVDs — govern through the CE marking regime. National overlays administered by the Direction de la santé: manufacturers and authorised representatives established in Luxembourg must register with the Direction de la santé (registration in EUDAMED satisfies the national registration requirement), and class I devices and IVDs must be registered with the Direction de la santé before being placed on the market.

If an establishment disputes a CAB's classification, it may apply in writing to the Authority within 30 days of the dispute, and the Authority must notify its decision within 30 days of the application.

Risk classification is governed by the classification rules of the Union Regulations; there is no Maltese classification schedule. An applicant, manufacturer or authorised representative with an official business address in Malta may nonetheless ask the Malta Medicines Authority to evaluate the risk classification of a device or an IVD, including in a dispute with the notified body over the application of Annex VIII (Classification Rules) of the MDR and IVDR. The fee for a request for confirmation of risk classification is EUR 1,000, on a 90 working day processing timeframe.

Medical devices are grouped into risk classes I, IIA, IIB and III according to the risks in use, on the basis of eighteen rules. The device classes are defined in the law by the level of risk for users: class I devices present a reduced risk, class IIA an increased risk, class IIB a high risk, and class III the highest risk. Devices are additionally characterised by duration (transient, short term, long term), by invasiveness, by implantability and by energy source (active and non active). In case of disagreement on the correct classification of a device, the classification is decided by the Agency.

Order A/136 §3.6 provides that in classifying a given medical device by risk grade, the risk grade to which it belongs in the country of manufacture may be taken into account. The verb is permissive (болно, "may"), not mandatory, and it does not name any foreign regulator, class scheme or approval.

Under the Agency head's Order A/136, medical consumables and medical equipment are classified by risk grade as low (I), medium (IIa, IIb) or high (III), and laboratory diagnostic devices (IVDs) are classified by risk grade as low (A), medium (B, C) or high (D). Classification of devices considers five factors (invasiveness, duration of use, body site, purpose of use, active/ non active) and IVDs three factors; where more than one class could apply the highest class prevails. The classification list is built on the international GMDN nomenclature and is submitted to the Agency.

Article 17 divides general medical devices by risk to the user into class I (low risk), class IIa (low to medium risk), class IIb (medium to high risk) and class III (high risk). The Ministry prescribes detailed classification conditions and the method of classifying individual devices.

Devices are classified by degree of danger: class I (low potential risk), class IIA (moderate), class IIB (high), class III (critical). The classification criteria are duration of use, invasiveness, intended purpose (surgical or not), active or non active character, and whether a vital part of the body is involved. The AMMPS registration dossier additionally applies the sub classes Is (sterile) and Im (with a measuring function) of class I, and a separate column for devices emitting ionising radiation.

Schedule 2 rule outcomes: mammary implants Class III (rule 22); devices incorporating a medicine Class III (rule 14); contraception devices Class IIb, implantable/long term invasive contraception Class III (rule 15); blood bags Class IIb (rule 19); reusable surgical instruments for transient use Class I (rule 7(4)); active implantable devices Class AIMD with controllers/monitors of AIMDs Class III (rule 20); export only devices Class I (rule 21); contact lens disinfectants Class IIb (rule 16).

axis: Classes I, IIa, IIb, III and AIMD (Medicines (Database of Medical Devices) Regulations 2003). · classes: id: i · label: Class I · normalizedRiskLevel: low; id: iia · label: Class IIa · normalizedRiskLevel: medium; id: iib · label: Class IIb · normalizedRiskLevel: high; id: iii · label: Class III · normalizedRiskLevel: highest; id: aimd · label: Class AIMD · normalizedRiskLevel: highest · regulator: Medsafe · notes: regs 11 13 + Schedule 2: 22 GHTF derived rules applied to the intended purpose (rules 2 and 10 default non invasive and active devices to Class I); where multiple rules apply the highest classification prevails (reg 13(7)).; Medsafe guidance additionally describes Class I sterile and Class I measuring sub classes and recommends working from rule 22 backwards; sponsors self classify (Medsafe does not determine classifications).; Rule outcomes: mammary implants Class III (rule 22); devices incorporating a medicine Class III (rule 14); contraception Class IIb, implantable/long term invasive contraception Class III (rule 15); blood bags Class IIb (rule 19); reusable surgical instruments for transient use Class I (rule 7(4)); active implantables Class AIMD with their controllers/monitors Class III (rule 20); export only devices Class I (rule 21); contact lens disinfectants Class IIb (rule 16).

Classification principles (reg 13): software that drives or influences a device has the same risk classification as the device; accessories are classified separately from the device; devices used in combination are each classified separately; classification follows the intended purpose and, where several rules apply, the highest classification prevails.

The sponsor determines the device's risk classification and, when notifying, declares that the product is a medical device and is correctly classified; Medsafe does not classify devices and states it is not able to make a classification determination.

IVD classification: Class A low individual and low public health risk; Class B low moderate individual and/or low public health risk; Class C high individual and/or moderate public health risk; Class D high individual and high public health risk (s.2.2).

Classification follows GHTF/SG1/N077:2012 Principles of Medical Devices Classification as acknowledged in the conformity assessment guideline (non IVD), with class based conformity assessment tables for Classes A D.

axis: Risk classes A through D for devices and IVDs (NAFDAC registration guidelines 2025). · classes: id: a · label: Class A · normalizedRiskLevel: low; id: b · label: Class B · normalizedRiskLevel: medium; id: c · label: Class C · normalizedRiskLevel: high; id: d · label: Class D · normalizedRiskLevel: highest · regulator: NAFDAC · notes: Section 2.1: Class A low risk, B low to moderate, C moderate to high, D high risk, or any other class the Agency deems fit; where a device belongs to more than one class the higher risk class applies.; Section 2.2 IVDs: Class A low individual/low public health risk; B low moderate individual and/or low public; C high individual and/or moderate public; D high individual and high public.; Non IVD classification follows GHTF/SG1/N077:2012 Principles of Medical Devices Classification as acknowledged in the NAFDAC conformity assessment guideline for non IVD devices (class based conformity assessment tables for Classes A D).

By duration of use in humans devices are classified as transient (used continuously for less than 60 minutes), short term (used continuously for up to 30 days) and long term (used continuously for more than 30 days).

In vitro diagnostic devices are classified as IVDs used exclusively by professionals and classified according to the type of device into List A and List B; IVDs for self diagnosis; and all other IVDs.

By their nature, power source and other characteristics devices are classified as non invasive, invasive and active.

Medical devices are classified by potential risk to users as class I (low risk), class II a (high risk), class II b (higher risk) and class III (highest risk).

Oman's risk class is determined by the classification of the device in its country of origin jurisdiction (KSA MDMA, USA, EU, Canada, Australia, Japan or other), stated in the application Section 1

Applications with incorrect risk classification may be required to re submit according to the appropriate risk class (GD3 Chapter Two item 5)

axis: GHTF style risk classes A through D set by MoH Circular 182/2021. · classes: id: a · label: Class A · normalizedRiskLevel: low; id: b · label: Class B · normalizedRiskLevel: medium; id: c · label: Class C · normalizedRiskLevel: high; id: d · label: Class D · normalizedRiskLevel: highest · regulator: Ministry of Health · notes: Mapping per Circular 182/2021 risk classification table: Class A (low) = Class I devices and general/exempt IVDs; Class B (low moderate) = Class II / Class IIa and self test IVDs; Class C (moderate high) = Class IIb / Class III and Annex II List B IVDs; Class D (high) = all other Class III / Class IV / AIMD and Annex II List A IVDs.; Risk class is determined by the device's classification in its country of origin jurisdiction (KSA MDMA, USA, EU, Canada, Australia, Japan or other), stated in application Section 1.; Applications with incorrect risk classification may be required to re submit according to the appropriate risk class (GD3 guideline, Chapter Two item 5).

PENDING DRAFT (not in force): Class A devices would follow an inscription only route (no Certificado de Registro Sanitario); class per manufacturer's declaration of conformity — draft Arts. 58, 75, 118 121

Pending draft decree: devices classified as Class A would not require a Certificado de Registro Sanitario but must be inscribed with DNDM; the class A inscription certificate would be valid five years. IVDs grouped in four classes per GHTF/IMDRF rules, with class A IVDs likewise inscription only.

Registration procedure and requirements are built on the device's risk classification using the most updated GHTF/IMDRF classification; DNDM is the competent body for risk classification and its classification decisions are binding, taking into account the manufacturer's recommendation.

axis: Risk classes A through D per the most current GHTF/IMDRF classification (Ley 90 de 2017). · classes: id: a · label: Clase A · normalizedRiskLevel: low; id: b · label: Clase B · normalizedRiskLevel: medium; id: c · label: Clase C · normalizedRiskLevel: high; id: d · label: Clase D · normalizedRiskLevel: highest · regulator: MINSA (DNDM) · notes: Ley 90 Arts. 16 and 23: the most current GHTF/IMDRF risk classification applies; class declared by the manufacturer and confirmed bindingly by the Dirección Nacional de Dispositivos Médicos.; Pending draft (not in force): a draft decree would route Class A devices through inscription only (no Certificado de Registro Sanitario) per the manufacturer's declaration of conformity (draft Arts. 58, 75, 118 121).

Resolución DINAVISA N° 226/2024 approves the Medical Device Classification Rules in Annex I, which may be updated according to internationally recognised provisions and taking account of technological progress and adverse event information. The applicant's responsible technician declares the class in DINAVISAPy with a technical justification, DINAVISA may accept or reject classes II, III and IV, and class I is classified under sworn declaration following Annex II.

In vitro diagnostic products are classified by individual risk and public health risk: class I low individual and low public health risk; class II medium; class III high individual and/or medium public health risk; class IV high individual and high public health risk. Annex III of the resolution contains the international classification rules.

Where a classification dispute arises between a manufacturer and a notified body (MDR Art. 51(2) / IVDR Art. 47(2)), the President of URPL resolves it by administrative decision; URPL provides a national application service for such disputes.

Medical devices are classified into four classes (A, B, C, D) based on the level of risk to the end user and their intended purpose. Class A is the lowest risk (examination gloves, tongue depressors) and Class D the highest (cardiac pacemakers, implants, IUDs); Class B is low to moderate (electronic thermometers, blood transfusion tubes, hypodermic needles) and Class C moderate to high (lung ventilators, condoms, infusion pumps). Where a device can be classified into more than one class the higher risk class applies. Where one device is intended to be used together with a different device a separate submission must be made and conformity assessed separately. The manufacturer has the primary responsibility to classify its devices, but the Authority may challenge the classification and has the final say. The guideline also sets out detailed classification rules modelled on the IMDRF rules, covering non invasive, invasive, active and special devices.

Medical devices are classified in four categories according to the level of risk they present: class A (low), class B (low/medium), class C (medium/high) and class D (high). The decree sets out the classification rules article by article in the same structure as the WHO/IMDRF scheme adopted regionally — for example, all non invasive devices that come into contact with lesioned skin are class A if intended only as a mechanical barrier, for compression or for absorbing exudates; class B if intended mainly for wounds involving destruction of the dermis, including devices intended mainly to treat the microenvironment of a lesioned mucosa; class C if intended mainly for wounds involving destruction of the dermis that can only heal by second intention. In vitro diagnostic devices are class C except for the determination of the ABO, rhesus, Kell, Kidd and Duffy systems, which are class D.

Low risk tier = listed devices plus Class I general medical devices and Class A IVDs which are non active, non sterile and without measuring function (Appendix 1 product list, e.g. adhesive bandages, hospital beds, bedpans). Sterile/active/measuring Class I and Class A devices are excluded.

axis: EU based risk classes I, IIa, IIb and III for general devices and A D for IVDs (NMRA GL 037). · classes: id: i · label: Class I · normalizedRiskLevel: low; id: iia · label: Class IIa · normalizedRiskLevel: medium; id: iib · label: Class IIb · normalizedRiskLevel: high; id: iii · label: Class III · normalizedRiskLevel: highest · regulator: NMRA · notes: GL 037 Section 5: classification follows the principles and rules of the EU Medical Device Regulations general devices Listed / Class I / IIa / IIb / III; IVDs Class A / B / C / D.; Low risk tier (GL 037): listed devices plus Class I general devices and Class A IVDs which are non active, non sterile and without measuring function (Appendix 1 product list); sterile/active/measuring Class I and Class A devices are excluded from the low risk route (Section 6 exemptions name Class IIa, IIb, III and IVD Class B, C, D).

Tunisia applies the European MDR risk class taxonomy rather than a national classification scheme: the manufacturer's declaration of conformity in the Tunisian device dossier must state the device's risk class as I, Is, Im, IIa, IIb or III, and the dossier guide's sole normative reference is Regulation (EU) 2017/745. The conformity evidence the guide requires is likewise the EU certificate issued under that regulation according to the device's risk class.

The NDA surgical instrument registration guideline groups medical devices into four risk classes: A (low), B (low to moderate), C (moderate to high) and D (high). Classification uses the technical rules in Appendix VII; where more than one rule applies, the highest applicable class is used.

IVDs are risk structured via Annex 2 lists to TR 754: List A (blood group ABO/Rhesus/anti Kell reagents; HIV 1/2, HTLV I/II, hepatitis B/C/D markers; vCJD blood screening tests), List B (anti Duffy/anti Kidd, irregular antibodies, rubella/toxoplasmosis, CMV, chlamydia, HLA, PSA marker, trisomy 21 risk, and self testing blood glucose meters); self testing devices (self control) are those intended by the manufacturer for home use; all other IVDs are 'general'.

Designated body involvement thresholds (DLS FAQ): a designated body is required for class I with measuring function, all class IIa, IIb, III, all sterile devices, IVDs in List B and self testing IVDs, IVDs in List A, and active implantables; NOT required for class I (non sterile, non measuring), general IVDs, custom made devices and procedure packs/systems.

axis: Risk classes I, IIa, IIb and III under Technical Regulation 753 (Annex 2 rules 9 26). · classes: id: i · label: Class I · normalizedRiskLevel: low; id: iia · label: Class IIa · normalizedRiskLevel: medium; id: iib · label: Class IIb · normalizedRiskLevel: high; id: iii · label: Class III · normalizedRiskLevel: highest · regulator: DLS · notes: TR 753 point 14: medical devices are divided into classes I, IIa, IIб and III; classification rules in Annex 2 (rules 9 26: non invasive, invasive, active, special); criteria include invasiveness, duration of use, body contact, action on vital organs, energy source.; Durations: temporary up to 60 min continuous use, short term up to 30 days, long term from 30 days.; IVDs are structured via TR 754 Annex 2 lists (List A blood group/transmissible agent reagents; List B incl. self testing blood glucose meters) plus a self testing category, not an A D class axis.; Designated body required for: class I with measuring function, all class IIa/IIb/III, all sterile devices, IVDs in List A/B and self testing IVDs, and active implantables; not required for class I (non sterile, non measuring), general IVDs, custom made devices and procedure packs/systems (DLS FAQ).

axis: Safety (potential risk) classes I, IIa, IIb and III (CM Resolution 738, Annex 2, para 4). · classes: id: i · label: Class I · normalizedRiskLevel: low; id: iia · label: Class IIa · normalizedRiskLevel: medium; id: iib · label: Class IIb · normalizedRiskLevel: high; id: iii · label: Class III · normalizedRiskLevel: highest · regulator: Ministry of Health · notes: Four classes: I low, IIa medium, IIb high, III highest; the four level classification was mandated from 01.01.2026 by Presidential Decree PF 137 para 3(г).; The class is declared by the applicant in the trilingual application (field 'Potensial xavf sinfi') and displayed in the State Register and on the certificate; class drives review time (60/90/120 working days), laboratory testing and clinical study duties.

statement: Medical devices are classified into four classes, Class A (lowest hazard) to Class D (highest hazard), using the classification rules in ZAMRA/MA/GUD/0002, which is an adaptation of the GHTF document Principles of Medical Devices Classification (GHTF/SG1/N77:2012). The guideline sets out classification rules for non invasive devices, invasive devices and active devices, plus additional rules, and the manufacturer determines the device class. IVD devices are classified in a parallel four class system based on individual and public health risk, and where more than one classification rule applies, or the device has multiple intended uses, it is allocated to the highest class indicated.

The Gloves Regulations apply to gloves used for any medical purpose and define 'glove' as (a) a single use medical glove protecting against cross contamination, (b) a sterile anatomically shaped surgical glove for invasive surgery, (c) an examination or procedure glove, (d) a seamed or welded glove made by bonding flat films, or (e) any other glove determined by the Authority; no glove may be sold unless it is of a type approved by the Authority, which may attach conditions to the approval. There is no risk class axis; the regulatory unit is the approved type (per brand).

statement: Zimbabwe operates no risk based classification system for medical devices. There is no Class A D scale, no classification rules and no classification guideline. The only differentiation in the device instruments is commercial and descriptive: condoms are approved per 'type and brand' (the MCAZ FAQ explains that for condoms 'a type of condom refers to variation for example, dotted, ribbed strawberry flavor, extra large etc.'), and gloves are approved per 'type', described by finishing dressing (powdered, powder free), use (examination, surgical) and material of construction (nitrile, latex, vinyl). Registration is therefore done per brand per type, with separate samples and forms for each. Any risk differentiation is instead achieved through the Second Schedule standards applicable to the class of device, not through a classification rule.