Advertising, claims & promotion by country

Advertising rules for devices are adopted by Council of Ministers decision, consistent with the device's characteristics summary; advertising must not contain information that: describes functions or features the device does not actually have; creates a false impression regarding treatment, diagnosis, functions or features; fails to inform the user or patient of a possible risk linked to use per the indication; or suggests uses other than those for which conformity assessment was obtained; violation is fined 200,000 lekë.

Wholesale and retail traders may buy and sell devices over the internet under the law and sub legal acts, but must communicate in advance to AKBPM the necessary information on the devices they will trade online; sale criteria are set by order of the minister responsible for health; failure to give the information is fined 200,000 lekë.

Under Disposición ANMAT 4059/25, only products holding the corresponding authorization may be advertised. For devices, the covered scope is products authorized with the condition 'uso sin prescripción' (per Art. 22 inc. c, Disposición 9688/19); self testing IVDs (para autoevaluación) are included in the scope.

Advertising for medical devices must include the legend 'LEA ATENTAMENTE LAS INSTRUCCIONES DE USO. ANTE LA MENOR DUDA CONSULTE A SU MÉDICO'.

Advertising of therapeutic goods (including medical devices) must comply with the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (F2021L01661), which specifies requirements to protect the public from unethical, inaccurate or misleading advertising practices.

Advertising material for medical devices must be limited to the approved intended purpose under the ARTG inclusion, and it is an offence to advertise a device by any means for any other purpose; the claim 'TGA approved' must not be used in advertising except with explicit TGA authorisation, and restricted representations require prior approval.

Statements on the intended purpose in advertising material for medical devices must not contradict the labelling and the instructions for use.

Consumer directed advertising is prohibited for: medical devices subject to prescription by ordinance under § 67 MPG 2021; devices intended to be used on or for patients by health professionals; and devices whose use may lawfully take place only in connection with medical or dental treatment or supervision.

No person may publish, disseminate or participate in any advertisement containing a claim regarding the use of a drug, or its curative or treatment effect, without prior approval of the Licensing Authority.

Advertising of medical products is prohibited without the advertiser holding Minhealth approval (согласование), which is an administrative procedure (8.14.2: 15 days, 1 month where expertise is needed, paid service). Advertising of devices not registered in Belarus is prohibited; advertising of devices not intended for patient self use is allowed only in specialized editions and professional events; ads must state the product is a medical product, the producer, and a recommendation to read the IFU/consult a doctor.

Every communication or advertisement of a device placed on the market must be in strict concordance with the information presented by the notification/registration holder to ANVISA (RDC 751/2022 Art. 32 for devices; RDC 830/2023 Art. 32 identically for IVDs).

When products on the market prove harmful or non compliant, the responsible company is obliged to broadcast alert advertising to the population, within the deadline and conditions set by the sanitary authority, subject to a fee for examination and prior approval (anuência prévia) of the content.

ANVISA's official advertising legislation page lists, under 'Produtos para saúde', only RDC 185/2001 which was revoked by RDC 751/2022 so no device specific advertising RDC currently appears in that index; the operative rules are the concordance clauses (RDC 751/830 Art. 32) and Lei 6.360/1976.

No person may advertise a device to the general public as a treatment, preventative or cure for any disease, disorder or abnormal physical state listed in Schedule A.1 of the Food and Drugs Act, and a device so advertised or so represented on its label may not be sold.

Advertising to the general public of any contraceptive device is prohibited except as authorized by regulation; MDR s.24 authorizes advertising for condoms only where the claim is limited to reducing the risk of contracting or transmitting sexually transmitted diseases.

Medical device advertising must be reviewed before publication by the advertising review authority designated by the province, and an advertisement approval number obtained;未经审查，不得发布. Content must be true and lawful, based on the registered/filed device IFU, without false, exaggerated or misleading claims.

Scientific, promotional or advertising information must follow the conditions of the registration/permit and current technical legal rules, stick to the truth with scientific evidence, and must not exaggerate benefits or mislead; Class IIa, IIb and III devices for exclusive professional use or requiring prescription may only be advertised in scientific or technical publications, unless the health authority authorizes other media; titulares and marketers are responsible for any breach.

INVIMA issues the authorization to advertise medical devices or biomedical equipment in Colombia under Article 58 of Decreto 4725 de 2005, issuing resolutions approving or denying advertising and non compliance (contraviene/no contraviene) opinions; requests use form 'SOLICITUD DE AUTORIZACIÓN DE PUBLICIDAD' code ASS RSA FM096.

EMB advertising must comply with the 'Reglamento para la autorización y control sanitario de la publicidad de productos de interés sanitario' in force (Decreto N° 36868 S, cited on the Ministry's advertising trámite page). Per that official trámite page, prior Ministry review/approval applies only to advertising of prescription only medicines and foods covered by Ley 7430 (breast milk substitutes) — not to EMB advertising generally. Advertising products without registration is a minor infraction; advertising uses differing from the registered ones, misleading advertising, creating false expectations, and promoting professional use EMB to the general public are grave infractions.

Personal use IVDs for detecting HIV, HTLV, hepatitis B/C/D or other sexually transmitted agents, or detecting an infectious agent in cerebrospinal fluid or blood, are not authorized by the Ministry for sale to the public, and mail order/telematic sale of unregistered EMB or products under the numeral 24 prohibition is a very serious category advertising/sales infraction.

CECMED establishes control of the promotion, marketing and advertising of medical devices to avoid communication of false or misleading information (E 132 25, epígrafe 3.53). CECMED additionally publishes a (pilot) reporting form for suspected falsified and illicit devices and for inappropriate promotion or advertising, enabling third party reporting.

Advertising of medical devices and IVDs within SÚKL's competence is regulated by Act No. 40/1995 Sb. on advertising regulation, Act No. 375/2022 Sb. and Decree No. 377/2022 Sb.; supervision is exercised by SÚKL's Department for Supervision of Medical Device Advertising (Oddělení dozoru nad reklamou zdravotnických prostředků, drzp@sukl.cz) within the Devices Regulation Section.

Disseminating, via communication media, advertising for devices or IVDs aimed at professionals where the media are not predominantly intended for professionals is an offence punishable by a fine up to CZK 2,000,000 (§ 8(1)(i), § 8(5)(c) of Act 40/1995 Sb.); non disclosure of the advertiser is punishable up to CZK 500,000 (§ 8(1)(a), § 7a); provision of free samples is prohibited (§ 8(1)(d)). UST 39 ties advertising oversight to the device notification duty under § 74(8) of Act 375/2022 Sb.

Advertising for medical devices must be adequate and factual and must not be liable to endanger the safety or health of patients, users or third parties; information must be consistent with the manufacturer's declared intended purpose and field of use, must not contain incorrect, misleading, exaggerated or deficient information, and factual claims must be documentable. Advertising must not give the impression that consulting a doctor/dentist/professional user is unnecessary, that the device is risk free, that wellbeing deteriorates without the device, be aimed mainly at children, induce erroneous self diagnosis, or use excessive, frightening or misleading images of disease effects or of the device's action on the body.

Advertising directed at persons other than professional buyers/dealers/users must not contain recommendations from scientists, health professionals or other persons/institutions whose standing could encourage device use, must not directly or indirectly mention serious diseases (DKMA may exceptionally permit mention where special health considerations so indicate, but never for TV, film or video), and must not contain references to studies, literature or journals. Advertising for devices intended exclusively for use by physicians or dentists in patient treatment is prohibited towards others than physicians, dentists and professional purchasers. Condoms/vaginal protective pouches may claim protection against listed STIs and dental care devices may claim preventive effects on plaque, caries, gingivitis or periodontitis.

Economic benefits to health professionals to promote device sales are prohibited, subject to narrow allowances (discounts, insignificant work related gifts, device loans up to 2 months for demonstration, reasonable payment for professional services, representation and professionally relevant training under conditions, sponsorship of public information meetings, no entertainment). Medicovirksomheder established in Denmark must notify DKMA by 31 January each year of health professionals and specified trade persons who received financial support for relevant activities abroad or international events in Denmark the preceding year, with name, e mail, profession and authorisation/CPR number; the data are published on DKMA's website and deleted 2 years after the activity ends. Patient associations must publish all economic benefits received from medicovirksomheder on their own websites within 1 month, kept available 2 years.

Advertising and promotion of products subject to sanitary control must conform to their true nature, composition, quality and origin so as to avoid any misconception of their qualities or benefits, and this is controlled by the national health authority; advertising by any means of prescription only medicines is prohibited (device specific restrictions are set in ARCSA advertising normativa).

Resolución ARCSA DE 2024 048 DASP (published Registro Oficial 7, 22 Jan 2025) issued the substitute sanitary technical norm for surveillance and control of advertising and promotion of medicines, processed natural products for medicinal use, homeopathic products and medical devices, in establishments and mass media.

In the labelling, instructions for use, making available, putting into service and advertising of devices, it is prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or patient with regard to the device's intended purpose, safety and performance including ascribing functions/properties the device does not have, creating false impressions regarding treatment or diagnosis, and failing to inform of likely risks (Art. 7 MDR).

In marketing, the manufacturer and the product or trade name given at registration must be stated; it must be indicated that the device is a CE marked medical device, and where a notified body certificate is required the notified body number must also be given; a product that is not a medical device may not be claimed to be one; devices intended to be placed on the market as devices whose conformity has not yet been demonstrated, and devices with a 58 § exemption permit, may be marketed only if the marketing states that the device is not CE marked; consumer marketing is additionally governed by the Consumer Protection Act (38/1978).

If a device is marketed in violation of 10 § or MDR/IVDR Art. 7, Fimea may prohibit continuing or repeating the marketing and may order the recipient of the ban to correct incorrect or deficient information given in the marketing where this is necessary because of endangered safety.

Advertising to the public for a medical device must include the device name/commercial reference, an express invitation to read the instructions, and a prudence message proportionate to risk referring to professional advice; it may not suggest that the device's effect is assured or that it has no adverse effects, may not refer to non scientific celebrity endorsement (except class I and IIa), may not offer premiums or material advantages (except class I/IIa and condoms), and may not claim reimbursement by statutory health insurance.

Advertising for certain medical devices presenting a significant risk to human health (list fixed by ministerial order) and for IVDs liable to cause a serious health risk is subject to prior approval by ANSM, granted for 5 years subject to the validity of the CE marking certificate; advertising for other devices is subject to retrospective control by ANSM.

The Heilmittelwerbegesetz (HWG, Act on advertising in the healthcare sector) applies under § 1 Abs. 1 Nr. 1a to advertising for medical devices within the meaning of MDR Art. 2(1) and for IVDs within the meaning of IVDR Art. 2(2), in the respectively applicable versions.

Anyone who professionally informs Fachkreise (healthcare professionals) about medical devices or instructs them in the proper handling of medical devices may exercise this activity only if they possess the requisite expert knowledge and experience (Sachkenntnis und Erfahrung); the rule also applies to information given by telephone.

A person shall not advertise a medical device to the general public as a treatment, preventive or cure for a disease, disorder or an abnormal physical state unless the advertisement has been approved by the Authority.

Despite the approval mechanism, a person shall not advertise a medical device for the treatment or cure of diseases specified in the Fifth Schedule to Act 851.

EOF's cited promotional/informational material submission regime (submission to the Τμήμα Ελέγχου Κυκλοφορίας under Article 130(2) of ΚΥΑ Δ.ΥΓ3α/Γ.Π. 32221/2013) applies to human pharmaceutical products, not medical devices.

Advertisements and commercial promotional materials must not contravene the Undesirable Medical Advertisement Ordinance (Cap. 231); MDD disapproves references to MDACS in advertisements except permitted exceptions (no claim of Government endorsement); an unjustified claim not withdrawn per DH instruction (which may require newspaper statements in at least four Chinese and one English newspaper) leads to delisting.

Medical aids receiving social health insurance (TB) funding may not be advertised (except under Gyftv. 17. § (4a)), and medical aids that may not lawfully be marketed in Hungary may not be advertised; NNGYK/OGYÉI is the advertising control authority under the Gyftv. (2006. évi XCVIII. tv.) and Grtv. (2008. évi XLVIII. tv.).

Advertisements for medical aids must carry the mandatory warning (per 3/2009 EüM rendelet 4. § (1)): 'A kockázatokról olvassa el a használati útmutatót, vagy kérdezze meg kezelőorvosát!' (Read the instructions for use about the risks, or ask your treating physician.)

Under the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954, 'advertisement' includes any notice, circular, label, wrapper or other document and any announcement made orally or by means of producing or transmitting light, sound or smoke. The Act's definition of 'drug' includes substances intended for diagnosis, cure, mitigation, treatment or prevention of disease and articles, other than food, intended to affect the structure or any organic function of the body.

No person may take part in publishing an advertisement referring to a drug in terms calculated to lead to its use for the diagnosis, cure, mitigation, treatment or prevention of a disease, disorder or condition specified in the Schedule or specified by rules under the Act.

An advertisement relating to a drug is prohibited if it directly or indirectly gives a false impression regarding the drug's true character, makes a false claim, or is otherwise false or misleading in a material particular.

A first conviction may be punished by imprisonment for up to six months, a fine, or both; a subsequent conviction may be punished by imprisonment for up to one year, a fine, or both.

The Act does not apply to an advertisement sent confidentially, in the prescribed manner, only to a registered medical practitioner. The Central Government may also exempt a specified drug or class of drugs from all or specified provisions of the Act subject to stated conditions.

Devices whose use requires the assistance of medical or health personnel may only be promoted and advertised in scientific media for medical and health personnel (media ilmiah untuk tenaga medis dan tenaga kesehatan). Promotion and advertising of any health supply must give objective, complete and non misleading information on benefits, contraindications, side effects and usage precautions, and comply with advertising ethics; the promotion/advertising procedure for devices and PKRT is set by the Minister.

Advertising to the public is prohibited for: (a) custom made devices; (b) devices whose use legally requires the assistance of a physician or other health professional; (c) devices whose use requires such assistance according to manufacturer indications; (d) devices whose sale to the public legally requires medical prescription. The Health Minister may identify further categories not allowed to be advertised to the public (Art. 26(2)).

Without prejudice to MDR Art. 7, advertising to the public of devices other than the banned categories is subject to authorization by the Ministry of Health; applications are reviewed by the section for health advertising licences of the Technical Health Committee (DPR 44/2013), following the procedure of Art. 118(8) (13) D.Lgs. 219/2006; the Minister may exempt categories by decree (Art. 26(6)) and regulates permitted modalities, including electronic systems, by guidelines (Art. 26(5)).

Information addressed to health operators (operatori sanitari) does not require authorization and is carried out in compliance with the modalities identified by Ministry of Health guidelines.

No person may advertise, describe or disseminate false or exaggerated claims — explicit or implicit — about the name, manufacturing method, efficacy, effects or performance of devices.

Advertising the name, manufacturing method, efficacy, effects or performance of devices that require approval or certification is prohibited until the approval (incl. foreign special approval) or certification is obtained.

Approval of the wording of an advertisement (brochure) or technical leaflets for a registered medical supply, sterilant or disinfectant is a JFDA service, i.e. such promotional/technical materials for registered products require JFDA approval.

Promotion of medicines and devices must be complete, accurate and objective per the ethics of promotion procedure; in medical organizations and health education organizations promotion by representatives of manufacturers is prohibited.

State control over compliance with advertising placement requirements for products subject to state sanitary control and state registration (including devices) is exercised per the Law of RK «On Advertising».

Under section 36(1) of the Pharmacy and Poisons Act (Cap. 244), no person shall advertise any drug or poison except with the written permission of the Board; related provisions (ss.37 39) prohibit advertisements for certain diseases and misleading or extravagant claims.

PPB's Guideline for Advertisement and Promotion of Health Products and Technologies covers medicines and medical devices; it sets out elements of advertisement and promotion, restrictions, and application procedures for obtaining approval to advertise and promote, and addresses advertisements not approved by the Medicines Regulatory Authority.

The enforcement authority may seize, impound and destroy unlawful advertising material, prohibit its use and publish that prohibition at the expense of the responsible persons, and may temporarily or permanently prohibit advertising for a specific therapeutic product in cases of serious or repeated violations of the advertising provisions of the therapeutics legislation (which includes medical devices under the HMG/customs treaty channel).

Luxembourg's competent authority page expressly lists the loi modifiée du 16 janvier 1990 relative aux dispositifs médicaux as the national legal basis governing medical device advertising, alongside MDR Article 7.

Labels and IFUs must not contain 8 categories of messages: implying no need to consult a doctor or undergo surgery; guaranteeing efficacy or safety; claiming that non use harms health; quoting organizations, scientists, health technicians or patients; exaggerated or fraudulent cure claims or images; unverified quality/effectiveness/safety content; content offending public morality.

Under the new Advertising Law, device advertisements must be filed with ISAF at least 5 working days before publication, with the ad specimen and documents substantiating its content; prohibited content includes efficacy or safety guarantees, claims that the product is necessary for health, and comparison with medicines (unless addressed to healthcare professionals). ISAF monitors device advertising and can impose conservation measures; violations are punishable by advertiser fines of MOP 5,000 to 80,000.

Medical institutions and medical personnel are banned from acting as advertising spokespersons for medical devices (as well as medical services, medicines, health products and milk powder); medical personnel are also banned from promoting devices as live stream marketers.

No person may advertise any registered medical device without approval from the Authority (fine up to RM200,000 and/or 2 years imprisonment); separately, section 44(1) Act 737 prohibits advertising any device that is not registered (fine up to RM300,000 and/or 3 years) and section 44(2) prohibits misleading or false claims.

Applications for advertisement approval are made in writing with a copy of the proposed advertisement and a processing fee of one thousand ringgit (RM1,000), plus an appointment letter if the applicant is appointed by the registration holder; the advertisement must contain a statement that the device is registered under the Act and the MDA registration number.

Advertising on the existence, quality and characteristics, or promoting the use, sale or consumption directly or indirectly, of insumos para la salud (which include devices) is subject to authorization by the Secretaría de Salud (LGS Art. 301); the regulatory provisions determine products/services for which only an aviso (notice) to the Secretaría is required (LGS Art. 301 bis). Fees are charged per product and message type (LFD Art. 195 I).

Catalogs of device insumos and promotional information in medical journals or print directed at health professionals are medios de difusión médica; the company responsible for such publications must file the corresponding notice (aviso) with the Secretaría.

Suppliers of medical devices are prohibited from promising, offering or granting benefits (gunstbetoon) to promote sales, with statutory exceptions (e.g. participation costs, services, benefits of small value, discounts and rebates).

Acting in violation of art. 7 of Regulation (EU) 2017/745 or art. 7 of Regulation (EU) 2017/746 (misleading claims) is a criminal offence in the Netherlands, punishable by imprisonment of at most two years or a fine of the sixth category; after two prior administrative fines for the same conduct it is punishable by up to six months' detention or a third category fine.

Advertising of devices with claimed therapeutic properties must comply with the Medicines Act and Regulations: Medicines Act 1981 Part 4 (ss 56 62) restricts false or misleading advertising, requires identification of the advertiser, and restricts claims for Schedule 1 disease/condition classes; 'publish' expressly covers advertising via the internet; Medicines Regulations 1984 regs 7, 10 and 11 add device advertising rules (including no claiming official approval).

No manufacturer or sponsor may publish any statement that directly or by implication indicates or suggests that inclusion of a device in the WAND database is an endorsement of its safety or suitability for use by the Director General or the Ministry of Health.

Registration of a device does not automatically confer an Advertisement Permit; a separate application and NAFDAC approval is required before a product may be advertised, per the NAFDAC Guidelines on Advertisement.

NAFDAC advertisement approvals are valid for one (1) year, extendable to two (2) years upon payment of double the relevant fee if the concept is retained; advertisement fees are charged per single product and per variant (per medium/concept/version/language).

Under rule 66(2), approval of a medical device advertisement is valid for two years; under rule 66(3), no person shall advertise a medical device for any purpose except that for which it has been enlisted or registered. Rule 64 prohibits advertising a medical device by any means except as provided under the rules, and Schedule C of the rules set a separate advertisement fee (PKR 20,000 as consolidated till April 2022).

Ley 90 places 'información' and 'publicidad' for devices within its regulated activities, and classifies non compliance with prohibitions on ambulatory (street) commercialization of regulated products as a minor fault (falta leve).

Promotion and advertising of prescription (venta con receta médica) devices aimed at prescribing/dispensing professionals must include the device's informe técnico, presented legibly, visibly, truthfully, exactly, completely and updated; scientific/clinical information must be supported by and consistent with the registration. D.S. 020 2024 SA (published 25/10/2024) modified Arts. 191 194 and added Art. 194 A.

Promotion and advertising of devices sold without prescription must state the main warnings and precautions corresponding to their registration; print media ads must carry the technical information visibly and legibly proportionate to ad size (suggested minimum 8 point type).

In health establishments it is prohibited to hand samples or free samples directly to patients and the public, or any other persuasion activity aimed at patients by medical visitors or company agents; companies may not install promotion modules, and medical visitors may not access consulting or hospitalization areas or interfere with health professionals' activities.

Under Book II, Article V of the IRR of RA 9711: no unregistered or unauthorized health product may be advertised, promoted or subjected to marketing activities; no claims may be made beyond those in the approved label or packaging or as approved by FDA; no therapeutic or scientific claims may be made without FDA approval.

Only products with a valid CPR may be applied for sales promotion (per RA 9711 Article V Section 2, as stated in FDA FAQ); sales promo permits are FDA issued services (CDRRHR chart 9 for devices), processed in about 7 working days, with campaign duration up to one year, extendable.

Online selling of prescription medical devices is prohibited; retailers may advertise prescription devices online but advertisements with a link for online purchase of prescription devices are not allowed.

Advertising a device available only on prescription or a device reimbursed under national health insurance in mass media, in generally accessible places or by means of distance communication is prohibited; advertising of other devices in those channels may not use the image of persons practising medical professions or presenting themselves as such.

Only an economic operator whose activity covers manufacturing, import, distribution or placing on the market of the advertised device may advertise devices; drawing up summaries of device characteristics or scientific data and their dissemination in scientific or specialist press, or at scientific or specialist events, does not constitute advertising if the requirements of Art. 54 57 are met.

Advertising directed at the public must include the warning: 'To jest wyrób medyczny. Używaj go zgodnie z instrukcją używania lub etykietą.' (This is a medical device. Use it according to the instructions for use or the label.); in press, internet, radio and TV advertising the warning must occupy at least 15% (press/internet) or 10% (TV screen) of the advertising surface/time, and in radio/TV it must be legible/audible for at least 4 seconds.

The entity advertising a device must keep, for 2 years from the end of the calendar year in which the advertising ended, copies of the advertising materials (wzory reklam) and information about the places and time of its dissemination, and must make them available at the request of the President of URPL.

Advertising of medical devices remains governed by DL 145/2009 Chapter XIII (kept in force by DL 29/2024 art. 52(5) until a new advertising law is published), supplemented by the Código da Publicidade (DL 330/90); INFARMED is responsible for monitoring and enforcing device advertising.

Advertising to the general public is prohibited for devices whose use requires the mediation and decision of a health professional, notably implantable devices, long term invasive devices, devices incorporating a medicinal substance or stable derivative of human blood/plasma, and devices manufactured using animal tissues.

ANMDMR is the competent authority for evaluating, notifying and approving advertising materials and any other form of advertising for medical devices, except advertising aimed at healthcare professionals when the device is not on the high population health risk list.

Documentation for advertising of a medical device aimed at the general public must be filed with ANMDMR by the manufacturer, importer or distributor for approval, and the advertising may be disseminated only after obtaining the advertising visa (viză de publicitate).

Advertising of a device on the high population health risk list aimed at healthcare professionals must be notified in advance, in emergency regime, to ANMDMR by the manufacturer, importer or distributor.

Public advertising is prohibited for devices with special purposes usable only on medical recommendation; public advertising is allowed only for devices intended to be used without intervention of qualified medical staff (pharmacist advice sufficing where needed).

ANMDMR analyses ex officio or on complaint breaches of the advertising chapter, orders cessation of already published advertising or prohibition of unpublished advertising, and obliges the offender to publish a corrective declaration approved by ANMDMR on the same channel; fines of 10,000 20,000 lei apply (Art. 29(33)).

Medical devices may be advertised or promoted only after SFDA approval. Two submission tracks: 1st Track advertising material submitted by the manufacturer/AR as part of the technical documentation within the MDMA application; 2nd Track a separate advertising approval application through the electronic portal. Track 1 approval validity is aligned with the MDMA validity; Track 2 approval is valid 1 year.

The advertisement language must be Arabic if directed at lay persons and English if directed at healthcare practitioners; other languages may be used in conformity with the advertisement's language. The same rule applies to awareness/charity campaign materials (English for professionals, Arabic plus English for lay users).

Only a medical device that complies with the essential requirements, or which is registered, may be advertised. Advertising must be truthful, scientifically proven and professional, must not mislead the public, and may not present illness or treatment success in a misleading, self regulation implying or sensationalist manner. Advertising to the general public and to the professional public is distinguished; the Minister prescribes conditions and manner of advertising (Pravilnik o oglasavanju medicinskog sredstva, 102/2018, ispravka 105/2018); ALIMS controls promotional material on the Ministry's proposal.

Advertisements must not contain statements that expressly or implicitly suggest the device's use is promoted or endorsed by the Authority (statements of registration and the registration number are permitted); statements of intended use or efficacy in advertisements directed at the public must be supported by objective evidence, which for registered devices is the data furnished at registration.

Advertisements promoting medical devices for diseases and conditions specified in the Second Schedule are restricted (reg 22; only distribution to qualified practitioners, pharmacists, nurses, midwives and trainees is permitted).

Advertising of devices is prohibited as defined by Art. 7 MDR and Art. 7 IVDR (misleading claims); devices intended for use only within healthcare activity may be advertised only to the professional public (health workers as defined by the healthcare activity law); mere display of devices listed in Art. 21(3) MDR / Art. 19(3) IVDR remains permitted.

When advertising to the professional public it is prohibited to give, offer or promise gifts, financial benefits or material advantages unless of low value (not exceeding the thresholds set for public officials); samples to the general public only in smallest packaging, marked as samples, with records kept; recipients of professional samples may not sell them.

Only Class A and Class B medical devices and IVDs may be advertised to the public or a lay person; despite this, male or female condoms may be advertised to the public.

An advertisement may not contain a statement deviating from, conflicting with or going beyond the evidence accepted by the Council in the registration application and incorporated into the approved instructions for use; a written advertisement must contain the device name and, for a registered device, its registration number.

Ads for medical devices using enumerated media (TV/radio broadcasting, daily/weekly/internet newspapers, magazines, banners/posters/leaflets, electronic boards, internet media) must undergo prior deliberation (자율심의) on whether they violate Article 24(2) (3); deliberation is performed by a self deliberation body registered with MFDS under Article 25 2.

No one may mark or advertise non device products on their exterior, packaging or accompanying documents in a way likely to mislead that they have performance, efficacy or effects similar to a medical device.

Manufacturers, distributors, marketers and any entities in direct contact with patients may not engage in direct or indirect advertising to the general public of a medical device that is funded by the Spanish National Health System (Sistema Nacional de Salud).

Advertising messages inserted in general media (including the Internet) and any other promotional material directed at the public are subject to prior authorization by the health authorities of the comunidades autónomas; the responsible region is that of the advertiser's registered office (or of the media outlet if the advertiser has no Spanish domicile); other promotional texts must remain available to the regional authorities for at least three months after dissemination.

In the framework of device promotion it is prohibited to grant, offer or promise premiums, pecuniary advantages or advantages in kind to healthcare professionals who prescribe the products, their relatives or cohabitants, who likewise may not request or accept such incentives.

Any person who wishes to advertise or promote a medicine, medical device or borderline product must obtain prior written approval of the Authority; devices may not be advertised or promoted to the general public for the treatment, prevention or cure of prescribed diseases, disorders or abnormal physical states. The NMRA Advertising Evaluation Sub Committee regulates printed and electronic advertisements.

Sweden enforces MDR/IVDR obligations nationally: administrative sanction fees (sanktionsavgift) can be imposed inter alia for violations of MDR Art. 7 (misleading claims) or Art. 10 16, up to SEK 100,000,000 (maximum SEK 10,000,000 if the payer is a government authority, region or municipality). Criminal liability: fines or imprisonment up to one year for intentionally or negligently placing non compliant products on the market, and up to two years for starting or conducting a clinical investigation unlawfully.

Advertising of devices may contain exclusively statements consistent with the product information; misleading claims are prohibited; public advertising is prohibited for devices intended exclusively for use by healthcare professionals.

Before publishing medical device advertising, the licence holder or filer must apply to the municipal or central authority with the advertising content for approval; after approval the holder must present the approval document to media operators before broadcasting, and the approved content may not be changed during the approved period. The approval document is valid for three years from issuance; extension is applied for within six months before expiry, each extension not exceeding three years.

Devices whose IFU states they must be used by healthcare professionals (and announced devices) may only be advertised in media aimed exclusively at healthcare professionals or at professional academic events. Advertising may not borrow others' names, guarantee efficacy or performance using publications/documents/materials, use interviews or news reports as promotion, or use other improper methods. Non devices may not bear or advertise medical efficacy claims (unless other laws provide otherwise).

No person may advertise any product regulated under Cap. 219 in a manner that is false, misleading or deceptive, or likely to create an erroneous impression regarding its character, value, quantity, composition, merit, safety or quality.

No person may carry out promotion activities on products regulated under Cap. 219 except after getting written approval from the Authority; retail advertising with bonuses, offers or discounts of regulated products is separately prohibited, with penalties from TZS 100,000 (individual) to TZS 1,000,000 or more (corporate).

Advertising a medical device requires a prior advertising permit (ใบอนุญาตโฆษณาเครื่องมือแพทย์); permit categories cover advertising to the public and advertising by giveaway items (gimmick) versus other forms.

Advertising directed at medical and public health professionals can be exempted from the advertising permit by ministerial notification, which sets the devices and the criteria, methods and conditions of the exemption.

Consumer directed advertising is prohibited for devices sold/applied only in hearing aid centers, custom prosthesis orthesis centers, opticians or dental prosthetics laboratories, and for devices intended exclusively for use/application by health professionals; advertising of remaining devices to consumers may only be done in the internet medium where the device is sold; Annex 3 (Ek 3) products (e.g. sensitivity toothpaste, denture care products, condoms, patient diapers, incontinence products) may be advertised freely to consumers.

Devices may not be presented to persons other than health professionals and technical staff working in medical device fields within health institutions and organizations.

Under Article 21 of the Law 'On Advertising', only devices/methods officially allowed for use in Ukraine may be advertised; ads must carry a consult a doctor warning and the text 'Самолікування може бути шкідливим для вашого здоров'я' occupying at least 15 percent of the ad area/duration; therapeutic effect claims for hard to treat diseases, guaranteed effects, fear appeals, and participation of doctors or medical workers are prohibited; telesales are banned.

Advertising, publicizing or promoting medical products by any means (visual, written, audio, social media) is prohibited unless approved by EDE; EDE's advertisement licence service completes in 3 working days with an AED 100 application fee, and the licence number must be printed on the approved designs.

An advertisement approval is valid from 30 days to one year at the applicant's choice; a new approval is required for each advertised product.

The Consumer Protection from Unfair Trading Regulations 2008 (the general regime covering misleading advertising to consumers, including device advertising) were revoked with effect from 6 April 2025 under the Digital Markets, Competition and Consumers Act 2024, with transitional provisions; the UK MDR 2002 contains no device specific advertising regulation or pre approval regime.

The advertising regime of Decreto 18/989 (propaganda limited to the approved pharmacological actions and doses; 30 day silence rule for unapproved indications) covers medicamentos and, via Art. 16, pharmaceutical products for medicinal, dental, cosmetic and dietetic use; it does not cover reactivos de diagnóstico, equipos médicos or dispositivos terapéuticos.

Under Article 16 of the Law "On Medicinal Products and Pharmaceutical Activity", information on medicines and medical purpose products is provided in the procedure established by the Ministry of Health, while advertising of medicines and medical purpose products is carried out in the procedure established by (general) legislation.

Device advertising operates via public disclosure (công khai) of intended advertising content and form using form Mẫu 16, filed by the circulation number owner or its written authorized organization, committing that ad content matches the disclosed version and the A/B declaration or C/D registration dossier.

Circular 09/2015/TT BYT (25/05/2015) established the prior confirmation regime (xác nhận nội dung quảng cáo) for special products under MOH; current device advertising uses the disclosure mechanism of Circular 44/2025.