Advertising, claims & promotion by country

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.

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.

Algerian statute names the publicity of medical devices expressly, alongside the publicity of pharmaceutical products, among the activities of the National Agency for Pharmaceutical Products (ANPP) from which the agency derives revenue: its resources include the fees (redevances) arising from 'l'enregistrement, l'homologation et la publicité des produits pharmaceutiques et des dispositifs médicaux, à usage de la médecine humaine', in accordance with the legislation and regulation in force. Device publicity is thereby placed on the same statutory footing as device registration and homologation as a regulated, fee bearing agency activity.

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

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.

The application (Form N 2) states the advertiser's identity and registration number, place of business, the specific device name, the medium to be used and contact details. It is accompanied by the advertisement text with scenario (signed and stamped, plus a Word version), the video clip in electronic form for electronic media, the power of attorney and identity document if filed by an authorised person, and proof of payment of the state duty. The application and materials may be lodged in person, by post or by e mail to info@moh.am; e mailed materials may not be supplied as links, and hard copy filings carry the materials on electronic media.

A permitted advertisement of a medical device must broadcast or display the number, day, month and year of the Ministry permit. Device advertising permits are numbered in the series ԲԱԳ with a five digit sequential number restarting each calendar year. If use of the medical device requires mandatory familiarisation with its instructions for use, the advertising text must include information to that effect.

An application may be filed only by the advertiser or a person authorised by it under the law. For medical devices, the advertiser may be a legal entity or individual entrepreneur that manufactures, imports, or sells wholesale or retail the medical devices concerned.

Article 15 part 7.4 delegates to the Government the procedure for granting device and medical method advertising permits, the list of documents and the content requirements, and provides that a state duty is charged for the permit under the Law on State Duty. The Government exercised this by Decision N 342 Ն of 27 March 2025 (Annex 1), which repealed the 2015 Decision N 1422 Ն and enters into force on the tenth day after official publication.

Article 15 part 7 of the Law on Advertising prohibits advertising medicines, medical devices and medical methods without a permit of the Ministry of Health of the Republic of Armenia. It further prohibits advertising of unregistered medical devices and of unlicensed subjects, and prohibits mass media advertising of medical devices whose use requires a physician's special prescription or supervision.

The advertising permit (Form N 1) is issued by the authorised state body in the health sector (the Ministry of Health). An application is granted or refused within 7 working days from the day the application and documents are submitted; time spent correcting formal errors (para. 10: notice within one working day, two working days to correct) is not counted.

When medical devices or medical methods are advertised through electronic or printed mass media or outdoor advertising panels, the advertisement must state the number and date of the Ministry of Health permit.

A permit application is refused if the documents are deficient, manifestly false or distorted, or any legally required document is missing and the deficiencies are not cured within the set period, or if the device advertising text contradicts the Laws on Advertising, on Licensing, on Medical Care and Services of the Population or on Public Health, the normative acts adopted under them, or the Decision's own requirements. The refusal order must state the reasons and the legal grounds. Refusal and termination orders may be appealed under the Law on Fundamentals of Administration and Administrative Procedure or in court.

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.

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.

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

Article 16 1 of the Law on Medicinal Products governs advertising in Azerbaijan and names medical equipment in its own terms. Article 16 1.1 provides that in the Republic of Azerbaijan only medicinal products dispensed without a prescription, medical purpose equipment ('tibbi təyinatlı texnika') whose use (application) has been authorised by the relevant executive authority, and treatment, prophylaxis, diagnosis and rehabilitation methods may be advertised — so an advertisement for equipment whose use has not been authorised by that authority is outside the permitted class. Article 16 1.4 requires the advertiser of prescription free medicinal products, medical purpose equipment and such methods to provide the advertising producer and the advertising distributor, on their request, with copies of the certificate issued by the Ministry of Health's accredited conformity assessment body or by accredited conformity assessment bodies, of the registration certificate confirming the state registration of the product, of the instructions for use (or, where the instructions do not state the dispensing arrangement, of a document containing the relevant information), of the certificate of origin, and, where research results are referred to in the advertisement, of the document confirming the research results. Article 16 1.6 provides that, subject to articles 16 1.1 and 16 1.4, advertising of products requiring special preparation for use, and of medical equipment, may be published only in press outlets specialised in the medical field and at events held for medical workers and pharmacists. Article 16 1.5 requires an advertisement to state that use of prescription free medicinal products and use of medical equipment is accompanied by adverse effects where that is the case, and to note the need to consult a doctor or specialist. Article 16 1.7 prohibits advertising campaigns accompanied by the free distribution or sale of medicinal products or by the provision of paid or free medical services. Article 16 1.3 disapplies the article 16 1.2.2 and 16 1.2.3 prohibitions (reference to concrete cases of recovery, and expressions of gratitude) to advertising published at exhibitions, seminars and conferences connected with medicine or pharmacy.

Under Article (10) of Resolution No. (48) of 2020 as amended by Resolution No. (69) of 2024, except for low risk home use medical devices, no person may market or advertise a medical device or product without prior authorisation from NHRA and payment of the prescribed fees. NHRA regulates advertising through its Advertising Guideline and an advertising application form.

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.

In the labelling, instructions for use, making available, putting into service and advertising of devices it is prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by: ascribing functions and properties to the device which the device does not have; creating a false impression regarding treatment or diagnosis; failing to inform the user or patient of a likely risk associated with the use of the device in line with its intended purpose; or suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

statement: Under Ley del Medicamento N° 1737 art. 59(f), advertising, promotion and propaganda of medicines directed at the general population without the prior authorisation of the Ministry of Human Development acting through the National Health Secretariat is a punishable infringement. The requirement is therefore a prior authorisation requirement, enforced through the infringement list rather than through a stand alone licensing article, and it sits alongside art. 50's delegation of the publication, promotion, propaganda and advertising of medicines to the Ministry on the basis of the Normas Éticas. The function is now exercised by AGEMED: art. 7(c) of DS 2905, recited in the VISTOS of RA 20/2023, gives AGEMED the function of evaluating, authorising, regulating, policing and inspecting, among other things, the 'promoción, publicidad ... de medicamentos y tecnologías en salud'. · article: Artículo 59(f)

statement: Bolivia's substantive rules on the promotion and advertising of medicinal products are the Normas Éticas para la Promoción de Medicamentos, approved on 1 March 1994 and published by AGEMED as technical norm T N 6. Numeral 4 states that the norms constitute legal obligations ('Las normas constituyen obligaciones legales'), with self regulation permitted only as a complement. Numeral 3 makes them applicable to medicines sold with and without prescription, to traditional medicines where relevant, and to 'cualquier otro producto anunciado como medicina', and directs them at government, the pharmaceutical industry, the advertising industry, health personnel, universities, professional bodies, patient and consumer groups and the media. Numeral 5 defines promotion as all informative and persuasive activities deployed by manufacturers and distributors to induce the prescribing, supply, acquisition or use of medicines. Numeral 6 requires active promotion within the country to be limited to legally obtainable medicines, to conform to national policy and regulations, and to be truthful, exact, accurate, informative, balanced, up to date, capable of substantiation and in good taste; it prohibits disparaging the Ministry of Health's health and medicines programmes through promotional activities or materials, declarations liable to misinterpretation or incapable of substantiation, and omissions that could induce a medically unjustified use or undue risks; it forbids the words 'inocuo', 'seguridad', 'carece de efectos secundarios', 'mejor' and 'más potente'; and it requires product comparisons to be factual, impartial and verifiable. The norms have statutory force because Ley 1737 art. 50 (Chapter XVI, Publicaciones, Promoción y Publicidad sobre Medicamentos) directs the Ministry to regulate publication, promotion, propaganda and advertising of medicines 'en base a las normas éticas para la promoción de medicamentos', and DS 25235 art. 96 provides that publication, promotion and advertising of medicines 'se regirá por las Normas Éticas para la Promoción de Medicamentos'. · article: Numerales 3 6

The provisions of Articles 73, 74, 75, 76 and 77 of the Act, which relate to the advertising of medicinal products, apply correspondingly to medical devices. The conditions and manner of advertising medical devices to the professional public, the level and direction of education and other conditions to be met by persons informing the professional public, and the conditions and manner of advertising medical devices to the general public, are prescribed by the Minister of Civil Affairs of BiH on the proposal of the Expert Council of the Agency.

BoMRA's Guideline on Advertisement and Promotion of Medical Products (BOMRA/PCT/PMS/P02/G01 Iss 2, effective 15 08 2020) states in its scope that it provides guidance on the requirements for the advertising and promotion of 'medical products including medicines, complementary medicines, medical devices, cosmetics, and veterinary medicines in Botswana', and within it the clause 'Products Allowed To Be Advertised' provides that only products that are registered with BoMRA can be advertised. Advertising or promoting an unregistered medical device in Botswana is therefore outside what that advertising control permits. The guideline records the legal basis of the control as s. 46(1) (4) of the Medicines and Related Substances Act 2013 and Regulation 53 of the Medicines and Related Substances Regulations; its definition of 'Related substance' includes medical devices, and its definition of 'Product' reaches 'related substances'.

BoMRA's Guideline on Advertisement and Promotion of Medical Products (BOMRA/PCT/PMS/P02/G01 Iss 2, effective 15 08 2020), whose scope expressly includes medical devices, sets out how advertising and promotional material is submitted to BoMRA for assessment: the applicant completes Service Request Form BOMRA QM P09 F01, submits it to the Finance and Administration office so that a proforma invoice is raised and pays for the advertising material to obtain proof of payment, then submits the advertising material, a cover letter and the proof of payment at the Records Unit; the cover letter must clearly state the product name(s), the registration number(s) and the type of advertisement being submitted for assessment. The guideline fixes the fee payable under the MRS Regulations 2019 for an 'Application for approval of advertisement or promotional material per product': print media P500 and electronic media P1000. The only product class the guideline allows to be advertised 'without seeking prior approval' is registered or cleared cosmetics, and veterinary medicinal products must be submitted to BOMRA for approval.

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.

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).

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.

Section 53(1)(a) of the Medicines Act prohibits publishing any medical advertisement that directly or indirectly claims, indicates or suggests that the article advertised will prevent, alleviate or cure any disease or condition in the Schedule, which lists 22 entries including AIDS, asthma, cancer, conception and pregnancy, deafness, diabetes, diseases of the eye, heart and kidney, epilepsy, hypertension, infertility, sexual function and tuberculosis. Advertisements distributed only to medical practitioners, dentists, pharmacists, nurses, midwives, veterinary surgeons and their trainees are exempt (s. 53(2)). The penalty is a fine of up to $5,000, up to 2 years' imprisonment or both (s. 53(3)).

Section 52 of the Medicines Act makes it an offence to issue a false or misleading advertisement or representation 'relating to medicinal products', including an advertisement inconsistent with the information approved at registration under s. 11; it does not extend to devices. Section 54(1)(b) empowers the Minister by order to prohibit advertisements likely to lead to the use of 'any medicinal product, or any other substance or article' for treating or diagnosing specified diseases, and s. 54(2)(b) allows orders requiring prior approval of advertisements by the Authority; no such order reaching devices is listed among the Act's subsidiary legislation.

Part 8 of the Medicines Act defines 'medical advertisement' as an advertisement relating, or likely to cause a person to believe it relates, to any medicinal product 'or any device, instrument, apparatus or contrivance used or represented to be used for a medicinal purpose'. This is the only provision of Brunei law that expressly regulates medical devices, and it does so through advertising control rather than product approval.

In the labelling, instructions for use, making available, putting into service and advertising of devices it is prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by: ascribing functions and properties to the device which the device does not have; creating a false impression regarding treatment or diagnosis; failing to inform the user or patient of a likely risk associated with the use of the device in line with its intended purpose; or suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

Medical device claims are subject to the regulatory control of the Member States, and as a general rule the claimed benefits of a device must be justified by substantial evidence or by the device's composition, formulation, component or preparation itself, in accordance with the essential principles of safety and performance. This is the device specific claims rule binding Cambodia.

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.

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.

Any form of publication or propaganda concerning hygiene, preventive or curative medicine and similar branches which, in the judgement of the health service, tends to deceive the public or to harm collective or individual health is prohibited.

No product may be advertised as 'medicinal, nutritive or of medical utility' other than those that have been authorised or recognised as such by the health service. The provision states the rule by claim category and does not enumerate product types.

Advertising purpose donation of pharmaceutical products is prohibited, as are incentives of any kind that induce preference for the use, prescription, dispensing, sale or administration of one or more pharmaceutical products to any person; the Ministry of Health may by reasoned supreme decree include certain 'elementos de uso médico' (elements of medical use, i.e. medical devices) within this prohibition; and 'incentive' is defined to cover any payment, gift, service or economic benefit given by anyone with an interest in preference being given to the use of one or more products or devices.

A medical device may be imported for display at trade fairs, exhibitions or demonstrations without undergoing conformity verification only on authorisation by the Director of the Instituto de Salud Pública, and a visible sign on the devices must clearly state that they cannot be commercialised or put into service until the applicable requirements have been met.

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.

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.

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.

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.

The competent national regulatory authority is charged with applying the regulation on promotion and publicity relating to medical devices, and the mandatory market surveillance system must include a control of promotion and publicity. In Côte d'Ivoire that authority is the AIRP.

Advertising of medical devices in Croatia is governed by Articles 59 and 60 of the Zakon o medicinskim proizvodima (NN 76/13). Article 59(1) defines advertising of a medical device as any form of communication whose purpose is to encourage the prescribing, sale or consumption of devices, in written, oral, pictorial, sound, electronic, digital or other form. Advertising a device that does not meet the conditions prescribed by the Act is prohibited, except for devices intended for exhibitions, demonstrations and fairs and the like, which must carry a visible marking that they are not intended to be placed on the market or put into service (Art. 59(2)); misleading advertising of a medical device is prohibited (Art. 59(3)); and devices intended exclusively for the performance of health care activity may be advertised only to health professionals (Art. 59(4)). Article 60 lists the content that device advertising must not contain: impressions that the device guarantees success in treatment or that the patient's health can improve only through the advertised device; impressions that health would worsen without it; encouragement to abandon basic generally accepted therapeutic procedures; material directed exclusively or predominantly at children; confusing use of scientific expressions unknown to the general public; appeals to statements by scientists, health professionals or other publicly influential persons; the claim that a product is safe merely because it is of natural origin; detailed descriptions of a pathological state that could lead to self diagnosis; inappropriate, disturbing or misleading statements about recovery prospects; inappropriate, disturbing or misleading images of disease induced changes to the human body; and material that endangers human dignity. This national layer sits on top of the Union rule: MDR Article 7 prohibits misleading text, names, trademarks, pictures and figurative or other signs in labelling, instructions for use, making available, putting into service and advertising, and Croatia penalises breach of Article 7 points (a) to (d) in advertising under Article 32(1) points 2 to 5 of the Zakon o provedbi Uredbe (EU) 2017/745 i Uredbe (EU) 2017/746 (NN 100/2018) with a fine of HRK 50,000 to 200,000.

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, and claims for, medical devices in Cyprus are governed directly by Article 7 of Regulation (EU) 2017/745, which prohibits the use of text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient as to the device's intended purpose, safety and performance in the labelling, instructions for use, making available, putting into service and advertising of devices. Cyprus has adopted no device specific advertising instrument: the general legislation inventory published by the competent authority lists only the harmonisation instruments for the Directives repealed by the MDR and IVDR, and contains no advertising measure. Advertising outside the device framework is dealt with under the general misleading and comparative advertising regime applied by the Υπηρεσία Προστασίας Καταναλωτή (Consumer Protection Service): Directive 2006/114/EC on misleading and comparative advertising, which the Service states it applies to cases where one trader has been misled by the advertising of another trader or is the victim of unfair comparative advertising, and the complaint handling mechanism of the Φορέας Ελέγχου Διαφήμισης (ΦΕΔ, Advertising Control Body), which the Service has recognised as an appropriate mechanism for examining whether an advertisement is misleading or unfairly comparative as between traders.

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.

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 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.

statement: Advertising and promotion of medicines, cosmetics, sanitary products and personal and household hygiene products in written, radio, television and social media channels addressed to the general public requires authorisation or notification from DIGEMAPS, under the reglamento brought into force by Resolución 000033 15 which regulates advertising and promotion of those products. The request is filed on form DIGEMAPS RS LI 058 with the advertising material in printed and electronic form and one fee payment per brand or product; the published cost is RD$1,000.00 for authorisations and no cost for a publicity notification, with a response time of 25 business days. · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: market oversight · localApplicationRequired: Yes · targetDecisionRetained: Yes

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.

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).

It is not permitted to advertise medical devices in any media outlet except after obtaining a written approval from the competent administration of the Egyptian Drug Authority; the import approvals guideline restates that devices may not be advertised in any media except after obtaining EDA approval.

Only scientific offices have the right to import samples for the purpose of advertising and marketing medical devices, and such samples must be printed with the statement that they are samples for advertising and not for sale.

Estonia has no device specific advertising statute; device advertising is governed by the general Advertising Act (Reklaamiseadus), and the Act expressly names medical devices in the bodies that supervise and prosecute it. Under § 30(2)(1), in addition to the general supervision of the Consumer Protection and Technical Regulatory Authority (Tarbijakaitse ja Tehnilise Järelevalve Amet, TTJA) under § 30(1), Ravimiamet supervises compliance with the requirements of Chapter 2 of the Act in respect of medical device advertising (and Chapter 2 plus § 18 in respect of medicinal product advertising); under § 36(2)(1) Ravimiamet is the extra judicial body for the misdemeanours under §§ 33–35 in respect of violations of Chapter 2 in medical device advertising. The substantive general rules that therefore apply to a device advertisement are: it must be clearly distinguishable from other information under ordinary attention, and its content, design and manner of presentation must ensure that it is understood to be advertising, and it must clearly contain the name of the advertiser and its registered or applied for Estonian or European Community trade mark or domain name (§ 3(1)–(2)); advertising that in any way misleads or is likely to mislead the persons to whom it is addressed or whom it reaches and which, by its misleading character, may affect their economic behaviour, or which for those reasons harms or may harm a competitor of the advertiser, is prohibited (§ 4(1)), and advertising is deemed misleading in particular where it gives misleading information about the availability, quantity, composition, usability, presence of accessories, technical data, the risks connected with use and storage including environmental safety, the manner and time of production, supply or provision, or the place of production or country of origin (§ 4(2)(1)); and advertising of technically complex goods, goods containing dangerous substances, or goods requiring special skill in use must contain a call to read the instructions for use and, where necessary, to consult a specialist, while advertising of goods intended for professional use only must contain information to that effect (§ 7(1), (3)).

Ethiopian law makes it illegal to advertise medicine and medical devices or to promote within a health institution unless the appropriate executive organ grants permission to the advertisement (Proclamation No. 1112/2019, Art. 59(4)). This is an express statutory control on device advertising that names medical devices directly.

Any direct advertisement or promotion made in person to a health professional must be made through a medicine or medical device promoter who is duly authorised by the executive organ. The statute also prohibits offering or giving, directly or indirectly, any financial, in kind or comparable benefit to a health professional in relation to promotion, beyond the maximum allowable gift defined by a directive issued to implement the proclamation. Advertising and promotion of regulated products must not be false and misleading, must be appropriate and ethical, and must comply with the proclamation and other applicable laws.

The advertiser and the advertisement disseminator of any regulated product, and, where the subject is promotion, the distributor or other person who caused the distribution of promotional materials, including a medicine and medical device promotion agent, have joint and several responsibilities for compliance with the proclamation and other applicable laws. Every mass media and advertisement disseminator has a duty to comply with a directive issued under the proclamation. Medical devices are within the class of regulated products to which these duties attach.

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).

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.

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).

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.

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.

Georgia's advertising regime is the general Law of Georgia on Advertising. The Law governs legal relations arising in the course of the production, placement and dissemination of advertisements of commodities (works, services) and of the financial market of Georgia, and an 'advertisement' is information about goods, services and works disseminated by any means and in any form that is intended for an unlimited group of persons and serves to form and maintain interest in goods and to facilitate their sale. 'Improper advertising' is unfair, unreliable, unethical, misleading or other advertising that violates the requirements for content, timing, placement and dissemination established by the legislation of Georgia; 'unreliable advertising' is advertising containing untrue data about the qualities of goods, their ingredients, the place, way and date of production, the purpose, consumer properties, conditions for use, certification marks or compliance with state standards, quantity, availability of products on the market, price, warranty obligations, the results of a product investigation and tests, and the actual demand for the product. The placement and dissemination of improper advertisements is prohibited and entails liability under Georgian legislation; liability falls on the advertising customer, producer and disseminator, and a person whose rights and interests are infringed by improper advertising may claim damages in court and require public refutation of the improper advertising. The Law's special advertising regimes are reserved to named product classes — pharmaceutical products, artificial baby food, weapons, securities, sex related products, tobacco, alcohol and human organ/tissue/cell matters — and medical devices are not among them, so a device is advertised as an ordinary commodity under the general rules. Two general provisions bite directly on a device: advertising goods whose production and sale is prohibited by Georgian legislation, or which require a special permit (licence) not yet obtained, is inadmissible, as is advertising an economic agent whose activity requires a special permit (licence) not yet obtained; and advertising of goods that require a special certificate must be marked with the word 'certified'.

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.

The Código de Salud requires that all advertising, promotion or propaganda for the products covered by its health products chapter be governed by ethical criteria and give the user truthful, exact, balanced and up to date information, so that the user can apply their own judgement and take the option most in keeping with their interests.

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.

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.)

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.).

Advertising medical devices in Iceland is permitted subject to the limitations in the Regulations and the Act. Advertising must always be presented objectively and give adequate information about the device, its characteristics and its use, and the user or patient must be informed of the potential risks associated with use of the device in accordance with its intended purpose. The Minister may set further rules by regulation, including prohibiting particular advertising methods or advertising of particular classes of device. In labelling, instructions for use, making available, putting into service and advertising it is prohibited to use text, names, trademarks, images or figurative signs that may mislead the user or patient as to the device's intended purpose, safety or performance. Breach of the claims provision carries the penalties under Article 44.

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.

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.

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.

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.

An advertising licence in respect of the claims put forward in an advertisement for any material or product within the Directive's scope — which includes medical equipment — is issued only in accordance with the confirmation (تأییدیه) of the Ministry of Health, Treatment and Medical Education or of the other relevant authorities.

An advertising licence is issued only for permitted materials, products and services, and only where the persons, companies and institutions concerned have previously obtained from the Ministry of Health, Treatment and Medical Education, the Medical Council Organization or other competent health sector authorities the establishment, operation or manufacturing licence, or the product import and distribution licence, or the medical/paramedical services licence covering the subject of the advertising. The authority for enquiries on materials and products is the Food and Drug Organization.

Advertising of medical equipment (تجهیزات پزشکی), together with the other health products and medical matters listed in Art. 1, requires an advertising licence from the Medical Council Organization (سازمان نظام پزشکی) when carried out through any of the media listed in Art. 3. Those media expressly include advertisements appearing on product packaging and labels, environmental advertising of any kind, printed matter such as leaflets, catalogues, brochures, posters and guide booklets, exhibition stands, virtual social networks and websites. Art. 1(c) defines medical equipment as everything covered by the Medical Equipment Regulation approved in 1386 by the Ministry of Health, Treatment and Medical Education and its subsequent amendments.

The use of comparative and superlative adjectives — the best, the most superior, the first, the best equipped and similar — in advertising is prohibited (Art. 14, a general provision that applies to all advertising within the Directive's scope, including medical equipment advertising under Art. 4). Separately, within the provisions governing the advertising of medical practices, offices and institutions (Arts. 20–24), Art. 23 permits publishing film or images of the practice premises but prohibits the publication in such advertising of an image of medical equipment that identifies a particular brand; the Directive does not state that this brand image prohibition extends to advertising placed by device manufacturers or distributors.

In the labelling, instructions for use, making available, putting into service and advertising of devices it is prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by: ascribing functions and properties to the device which the device does not have; creating a false impression regarding treatment or diagnosis; failing to inform the user or patient of a likely risk associated with the use of the device in line with its intended purpose; or suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

The Medical Equipment Law defines advertising directed to the public (excluding scientific literature), permits the registration of medical equipment to be made subject to conditions restricting the manner or content of its advertising, and authorizes the Director to restrict advertising whose manner or content harms or may harm public health. Except in an urgent public health case, the affected party must be given an opportunity to present arguments before a restriction is imposed.

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.

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)).

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)).

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.

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».

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.

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.

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.

Latvia applies Regulation (EU) 2017/745 directly, so the operative advertising rule for medical devices is Article 7 (Claims) of the MDR: 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 the patient with regard to the device's intended purpose, safety and performance — by ascribing functions and properties the device does not have (a), by creating a false impression regarding treatment or diagnosis, functions or properties the device does not have (b), by failing to inform of a likely risk associated with use in line with the intended purpose (c), or by suggesting uses other than those stated to form part of the intended purpose for which the conformity assessment was carried out (d). Latvia has enacted no device specific advertising instrument. The Cabinet Regulation that implements the MDR, Ministru kabineta noteikumi Nr. 461 "Medicīnisko ierīču noteikumi" (in force from 23.08.2023), contains no advertising provision and its scope clause (points 1.1–1.5) carries no advertising limb. The national layer that does apply is the general Reklāmas likums (Advertising Law): advertising must be lawful, truthful and objective and must comply with honest advertising practice and the principles of fair competition (s. 3(1)); misleading advertising is prohibited (s. 8(1)–(2)); supervision is shared between the Consumer Rights Protection Centre, the Competition Council, the National Electronic Mass Media Council and — for medicinal product advertising only — the Health Inspectorate (s. 13(1)); the supervisory authority may order the advertiser to add essential information, to remove elements from the advertisement, to prohibit its distribution or to require its withdrawal (s. 15(4)); and it may impose a fine of up to EUR 14,000 for advertising that does not comply with statutory requirements (s. 20(1)). The device specific advertising content rules that the Advertising Law enables the Cabinet of Ministers to lay down under s. 7(2) have never been adopted for medical devices, although they have been used for medicinal products (MK noteikumi Nr. 378).

Advertising for medical devices that have not been declared to the Ministry of Public Health is prohibited. Advertising material must not mislead the user as to the performance of the medical device as specified by the manufacturer.

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).

In the labelling, instructions for use, making available, putting into service and advertising of devices it is prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by: ascribing functions and properties to the device which the device does not have; creating a false impression regarding treatment or diagnosis; failing to inform the user or patient of a likely risk associated with the use of the device in line with its intended purpose; or suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

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.

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.

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.

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 of, and claims for, medical devices in Malta are governed directly by Article 7 of Regulation (EU) 2017/745, which prohibits the use of text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient as to the device's intended purpose, safety and performance in the labelling, instructions for use, making available, putting into service and advertising of devices. Malta has adopted no device specific advertising instrument: the Medical Devices and In Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations (S.L. 458.59), which is the whole of the Maltese device provision regime and runs to eleven regulations, contains no advertising provision at all, and the advertising controls of the Medicines Act (Cap. 458) are confined to medicinal products. Advertising of devices outside the device framework falls under the general misleading advertising rule of the Consumer Affairs Act (Cap. 378): unfair commercial practices are prohibited, a commercial practice is unfair if it is misleading under Article 51C or 51D, and "commercial practice" is defined to include any "commercial communication including advertising and marketing" by a trader directly connected with the promotion, sale or supply of a product to consumers, "product" being any good or service — so a misleading advertisement for a device is caught by that general regime as well as by Article 7.

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.

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).

Medical device advertising and promotional activity must follow the common principles in Art. 26.1: it must be based on information and instructions for use confirmed by the State administrative body in charge of medicines and medical devices; its content must be clear, understandable and compliant with professional ethical norms; and it must be based on scientific evidence and be accurate. Advertising through television, radio, billboards, professional press and the official website may be carried out by specially permitted manufacturers and suppliers, and the Agency grants the device advertising permit to the manufacturer or supplying organisation for the period provided in Art. 2.2 of the Law on Permits and Notifications, and monitors compliance.

An advertiser must keep records of: parallel promotions (name, seat and activity of the legal person carrying out the parallel promotion, and the expert associate's name, residence, employment and occupation); advertising messages (name of the device, the public information medium or website on which the message was published, and the advertising period); promotional material (name and purpose of the promoted device, type and quantity of the material, number and date of issue); the expert public to whom the material was delivered (name of the healthcare professional, employer, name and purpose of the promoted device, type and quantity, date of delivery); the expert public's requests for free samples (name of the prescribing or using healthcare professional, employer, quantity provided, date of delivery); and sponsored expert meetings (name, time and place, information on the expert public attendees, total funds spent, funds spent by item — travel, accommodation, meals, participation costs — and total funds spent on an annual basis). On the basis of those records the advertiser prepares an annual report on the advertising of medical devices, publishes it on its website and submits it to the state administration body responsible for health affairs. The advertiser keeps the original of advertising messages, promotional materials and published expert works for five years.

Advertising a medical device to the expert public is done by delivering promotional material, providing information at scientific and promotional events, in expert journals and other forms of promotion, giving a free sample, and sponsoring expert meetings in which the expert public participates, in accordance with the Law; the promotional material may be given only to persons belonging to the expert public. The promotional material must contain: the note 'For expert public only!'; basic information about the device which must be relevant, accurate, up to date, verifiable and sufficient for the expert public to form an expert opinion on it; the date of registration of the device; statements, tables or other data taken from expert journals or scientific papers which are current, relevant and faithfully conveyed, with reference to the literature and the exact source of information; and the date of creation and last revision of the promotional material. The promotional material must not contain the term 'safe' unless it refers to a description of a device containing appropriate explanations in accordance with the essential requirements. Advertising to the expert public may be carried out by persons employed or otherwise engaged by the advertiser with a VII1 level of education at an appropriate faculty, who have appropriate knowledge and additional training in the essential requirements for safety and performance of the advertised device, and the advertiser must provide them with continuous training and test their knowledge.

Advertising a medical device to the general public is done by publishing an advertising message through the public information media or the internet, in public places and in other forms of advertising, that is, by giving a free sample in accordance with the Law. The advertising message must give clear information that the advertised product is a medical device and must contain the name of the device, the manner of use and the data necessary for its proper use, and a warning to the patient or user — visibly, legibly and comprehensibly written, drawn or spoken — to read the instructions for use carefully and to consult a doctor of medicine, pharmacist and/or dentist about the purpose and adverse effects of the device. The warning must read: 'Read the instructions before use! Consult a doctor of medicine or pharmacist about the purpose and adverse effects of the medical device' (or, for devices intended for use in dentistry, consult a dentist or pharmacist). In print media it must be written in bold in an appropriate font, easily visible, occupying at least one tenth of the advertising message and framed by a straight line that does not affect its clarity and visibility; in electronic media it must be shown independently in a separate frame with an accompanying voice message of identical content; on the internet it must be an integral part of the home page, that is, the main page of the internet message or advertisement, and not of the page given as a link or reference to the main page. An advertising message must not create a false impression, among the eleven listed matters, that a device has no adverse effects, that consulting a doctor is unnecessary, that examination or surgery can be avoided, that use guarantees success, that one device is the best, that a device should be used even with no signs of illness, that the health of a non user will be impaired, that the device is food, a supplement, a cosmetic or a toy, that the device is or will be registered in the following period, that a prescribed device can be replaced by the advertised one, or that the device is harmless because of its natural origin; and it must not set out the price of a device, recommendations of healthcare professionals or scientific workers about its performance, or recommendations or the image of a popular person who could influence its use.

Advertising a medical device that is not compliant with the technical requirements, that is, that is not registered, is prohibited. Advertising a medical device that is misleading — that describes the disease and treatment successes in a way that leads to self medication, or that advertises a device in an inappropriate or sensationalist way about its treatment successes by displaying images and the like — is also prohibited, as is advertising devices dispensed at the expense of health insurance. For the protection of public health the Ministry may prescribe other medical devices that may not be advertised, and the Ministry prescribes the detailed conditions and manner of advertising medical devices.

Only medical devices holding a registration certificate may be advertised to the public. Advertising must not be misleading or harm the protection of human health; it must present the device objectively, encourage its proper use, and conform to the registration dossier. All information in the advertising must be exact, up to date, conforming to the legislation in force, verifiable and sufficiently complete to inform the recipient correctly about the real performance of the device. Labelling and instructions for use are outside the definition of advertising.

statement: Myanmar's Consumer Protection Law 2019 prohibits an entrepreneur from publishing any of six categories of advertisement: fraudulent advertisements about the quality, quantity, ingredients, mode of use, price, rate of service or time needed to deliver the goods or services; fraudulent advertisements about the warranty of goods or services; advertisements containing false information about goods or services; advertisements that are not informative about the risk of using the goods or services; advertisements using any person or event without that person's permission; and advertisements inconsistent with existing laws or ethics. The prohibition is a general one addressed to entrepreneurs in respect of 'goods or services'; a medical device is 'goods' within the Law's definition ('objects that are purchased, used or consumed aiming at a consumer or other persons'). No device specific advertising instrument, pre approval requirement or advertising code issued by the Department of Food and Drug Administration was located, so these general prohibitions are the advertising rules that apply to a medical device in Myanmar. · prohibitedAdvertisementCategories: quality/quantity/ingredients/mode of use/price/rate of service/delivery time misrepresentation; warranty misrepresentation; false information; failure to inform about the risk of use; use of a person or event without permission; inconsistency with existing laws or ethics · appliesTo: goods or services; a medical device is 'goods' under s. 2(d) · sanction: offence under s. 70 (Chapter XXIV, Offences and Penalties)

statement: Myanmar's Consumer Protection Law 2019 separately restricts sale promotion. An entrepreneur may not make a sale promotion regarding goods or services by offering to sell the goods at a special price within a period without any plan to sell the advertised amount or quality within that period; by offering to sell goods by pledging to pay a bonus or to provide free services which cannot actually be provided; or by any means that disturbs the consumer physically or mentally. The Law also makes it unlawful to produce, trade or sell goods or services that are not in conformity with the information stated on the label under s. 41, or that are not in conformity with the descriptions in the advertisement and sale promotion — so a promotional claim about a medical device must match the goods actually supplied. · prohibitedPromotions: unplanned special price offers with no plan to supply the advertised amount or quality; unfulfillable bonus or free service pledges; promotions that physically or mentally disturb the consumer · conformityDuty: s. 67(a) and (b): goods must conform to the label information under s. 41 and to the descriptions in the advertisement and sale promotion

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.

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.

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).

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).

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.

The provisions of the Law's advertising chapter that govern the advertising of medicines apply correspondingly to the advertising of medical devices. Advertising of medical devices used only in health institutions is prohibited. The Director of the Agency prescribes the methods of advertising medical devices and the fee for assessing the advertising documentation.

MALMED requires that a marketing authorisation holder or manufacturer informing the general public about a medical device that may be sold without a prescription do so only with prior approval from the Agency, and that the information be presented objectively and in accordance with the patient leaflet.

In the labelling, instructions for use, making available, putting into service and advertising of devices it is prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by: ascribing functions and properties to the device which the device does not have; creating a false impression regarding treatment or diagnosis; failing to inform the user or patient of a likely risk associated with the use of the device in line with its intended purpose; or suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

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).

As amended by Ley N° 7361/2024, Article 5 of Ley N° 6788/2021 charges DINAVISA with regulating and supervising the activities of natural and legal persons at every stage including 'información y publicidad' of health products, expressly listing medicines, drugs, chemical products, reagents, medical devices and every other product for use in human medicine.

Chapter III 'De la promoción y publicidad' of Ley 1119/97 consists of Article 25, whose eleven numbered rules (authority to set criteria, direct to public criteria, message content, ban on gifts, professional information, prohibition of advertising unregistered products) are all expressed in terms of especialidades farmacéuticas and medicamentos. The law's Article 1 nonetheless places 'publicidad' of every product within its scope, including reagents and 'todo otro producto de uso y aplicación en medicina humana'.

Article 27 of Ley 6788/2021, as rewritten by Ley 7361/2024, allows DINAVISA, without further formality, to adopt precautionary measures when a serious and imminent health risk exists or is reasonably suspected; the list includes quarantine, market withdrawal, prohibition of use, suspension of establishment activities, suspension of advertising of establishments and products, and provisional closure.

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.

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).

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.

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.

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.

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.

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.

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 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.

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.

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)).

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).

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 medical devices must be accompanied by a warning about contraindications to their use and the need to familiarize with the instructions for use or obtain consultation of specialists: at least 5% of the advertising area (space) in print and other media, at least 5 seconds and at least 7% of the frame area in television, cinema and video advertising, and at least 3 seconds in radio advertising. The warning requirement does not apply to advertising distributed at medical or pharmaceutical exhibitions, seminars, conferences and similar events, in specialized print intended for medical and pharmaceutical workers, or other advertising whose consumers are exclusively medical and pharmaceutical workers.

Statements in advertising about the properties and characteristics of a medical device, including its methods of application and use, are allowed only within the indications contained in the approved instructions for use of the device.

Federal Law No. 38 FZ 'On Advertising' extends points 1 8 of Article 24(1) to medical device advertising (Article 24(4)). Device advertising must not: address minors; reference specific cases of cure or improved health from use of the advertised device; contain expressions of gratitude by consumers; create an impression of advantage by reference to research that is mandatory for state registration of the device; assert or suggest that consumers have particular diseases or health disorders; create in a healthy person the impression that the device is necessary; create the impression that seeing a physician is unnecessary; or guarantee positive action, safety, efficacy or absence of side effects.

Advertising of medical devices whose use requires special training is not permitted other than at medical or pharmaceutical exhibitions, seminars, conferences and similar events, and in specialized print publications intended for medical and pharmaceutical workers. The same channel restriction covers prescription only medicines and methods of prevention, diagnosis, treatment and medical rehabilitation.

Rwanda FDA's promotion regulations apply to medical devices by definition: 'Regulated product' means processed foods, pharmaceutical products, vaccines, human and veterinary processed foods and other biological products used in clinical as drugs, food supplements, food fortificant, fortified foods, poisonous substances, herbal medicines, medicated cosmetics, 'medical devices', tobacco and tobacco products. Article 5 prohibits advertising, promoting or marketing any regulated product unless it is registered by the Authority, prohibits advertising or promoting any regulated product unless the advertisement or promotion has the clearance and approval issued by the Authority, prohibits carrying out a regulated product launch without prior written approval or clearance, prohibits promotion or advertisement that is directly or by implication misleading or calculated to mislead the population, requires packaging and labelling information consistent with the product information approved at registration, and requires all promotional materials to carry a disclaimer owning all claims stated in them as well as disowning third party claims. Article 6 requires promotional advertisements to be accurate, unbiased, complete, clear and designed to promote credibility and trust by the general public and healthcare providers, to be consistent with the approved product information and in line with the conditions or illnesses for which the product was registered, and provides that promotional material shall not contain misleading or unverifiable statements or omissions regarding quality, safety and efficacy or value which likely induce product use or give rise to undue risks; promotion must not state or imply that a product is 'safe', is '100% safe', has 'no side effects' or that its 'use will not cause harm'. Article 7 prohibits promotion before written approval, restricts promotion to the public in open markets, bus stands and moving vehicles, treats posters in public places as promotional material targeting the general public requiring approval, and prohibits advertising words such as 'Number one product' or 'the best product'. Article 8 makes it an offence to promote, advertise or market any regulated product in a manner that is false, misleading or deceptive or likely to create an erroneous impression as to its character, value, quantity, composition, merit, safety or efficacy, and treats imitation of another company's advertisement layout, slogans or visual presentation in a misleading way as false and misleading. Article 11 requires the final version of the advertisement in whatsoever form to be submitted for vetting before final publication; acceptable advertisements are communicated in writing with the unique reference number issued by the Authority for each advertisement, unacceptable ones with written clarification, and alteration of the format without express written permission renders the approval null and void. Article 18 gives the Authority power to issue the guidelines, SOPs and forms necessary for implementation. The official application requirements require, among nine documents, 'Tangible or scientific proof or facts to back up claims made by the applicant (where applicable)', samples of all promotional materials in final versions, the product registration certificates for the products to be promoted and the degree of the responsible personnel who approved the message; and the official application form for approval of promotional materials (FDISM/PVSM/FOM/010) carries 'Medical Device [ ]' as one of its product category options. Registration can be suspended where a registered device 'has been advertised in a manner which is false or misleading or does not comply with the provisions of the laws and regulations currently enforced by the Authority' (TRG/002 art. 24).

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).

Two instruments together govern promotion and advertising of medical devices in Senegal. First, Décret n° 2023 2419 art. 43 makes 'le contrôle de la promotion et de la publicité' an express component of the medical device post marketing surveillance system, so device advertising is a regulated post market activity controlled by the pharmaceutical regulation structure. Second, the substantive authorisation regime is Décret n° 2023 2424 du 27 décembre 2023 fixant les conditions d'autorisation de la promotion ou de publicité sur les médicaments et autres produits de santé, taken under art. 55 of Loi n° 2023 06: art. 1 fixes its object as the conditions for authorising promotion or advertising of 'médicaments et autres produits de santé'; art. 3 subjects promotion through an advertising medium or by the giving away of free units to an authorisation issued by the pharmaceutical regulation structure; art. 33 reserves advertising to products for which a marketing authorisation has been obtained and requires any advertisement to respect the marketing authorisation, to conform to the summary of product characteristics, to favour rational use and not to harm public health; art. 34 lists prohibited elements (presenting the medical act as superfluous, suggesting the effect is acquired, suggesting absence of side effects, claiming superiority or equivalence over another product, claiming that a normal state of health can be improved, assimilating the product to a foodstuff, referring to certificates of cure, insisting that a marketing authorisation has been obtained); art. 35 forbids anticipating pending variations; art. 36 requires comparative advertising to be based on comparable and relevant characteristics and not to be denigrating or misleading; art. 37 prohibits advertising to the general public; art. 38 reserves advertising strictly to public health professionals and requires the information to be exact, up to date, verifiable and sufficiently complete; art. 39 makes professional advertising controlled by the regulation structure and lists the permitted channels; art. 40 creates an evaluation and validation commission for advertising requests; art. 42 provides that the composition of the advertising authorisation dossier is fixed by decision of the Director General; art. 43 permits campaigns for priority health programmes to address the general public only where preventive or public health protective. Sanctions for advertising or promoting without authorisation are listed in art. 44: urgent stopping of the advertising campaign, urgent stopping of the promotion of the product, suspension of the marketing authorisation, withdrawal of the marketing authorisation, and a fine of 1,000,000 to 2,000,000 CFA francs, with the same fine for advertising on an unauthorised medium. The ARP also lists the UEMOA 'LIGNES DIRECTRICES POUR LE CONTRÔLE DE L'INFORMATION ET LA PUBLICITE SUR LES MEDICAMENTS AUPRES DES PROFESSIONNELS DE LA SANTE DANS LES ETATS MEMBRES DE L'UEMOA' in its official guideline library, matching the Décision n° 10/2010/CM/UEMOA cited in the visas of Décret n° 2023 2424.

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 of medical devices do not require prior approval by HSA, but they must comply with the Health Products Act and the Medical Devices Regulations. A product must not be advertised as a medical device unless it is a medical device under the First Schedule to the Act. Representations must be factual and substantiated by objective evidence, and must not give false information or an erroneous impression of components, composition, specification, quality, safety, efficacy or uses.

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).

In the labelling, instructions for use, making available, putting into service and advertising of devices it is prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by: ascribing functions and properties to the device which the device does not have; creating a false impression regarding treatment or diagnosis; failing to inform the user or patient of a likely risk associated with the use of the device in line with its intended purpose; or suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

Control of information and advertising concerning medicines and health products, and communication of relevant information to professionals and patients, is one of ANMPS's stated prerogatives. The same page defines the products over which the agency acts to include medical devices: ANMPS was created by Loi n° 2023 2 du 12 juillet 2023 and acts on human and veterinary medicines, medical devices, food supplements, cosmetic products and all other health products aimed at prevention, diagnosis or care before and after their placing on the market. The agency also lists supervision of medical promotion agencies among its inspection activities.

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.

NDA's medical devices page prohibits advertising registered professional use only devices unless the advertisement is distributed only to qualified practitioners or appears in a publication intended for them.

NDA's medical devices page places responsibility for compliance with device advertisement and promotion regulation and guidelines on the advertiser, and requires advertisement or promotional material to be submitted to NDA for vetting. 'Advertisement' is defined as the publication, dissemination or conveyance of any information for the purpose of promotion and the sale or use of the medical device by any means or in any form — including newspapers, periodicals, posters or notices, circulars and brochures, letters, photographs or films, broadcast and internet media, and public demonstration of device use.

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 visual, written, audio or social media means requires EDE approval. Article 44(2) prohibits public advertising of the controlled, semi controlled, hazardous or toxic products/substances it specifies; Article 44(3) allows EDE to prohibit or restrict advertising of other medical products.

To obtain advertising approval, the applicant must be a licensed pharmaceutical or healthcare establishment. Advertising must be truthful, not misleading, supported by evidence reflecting the product information and approved uses, and clearly disclose associated risks or side effects. A valid marketing approval is required unless the product is exempt under Article 5(3); additional audience specific controls also apply.

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.

A sponsor, investigator, or person acting for either may not promote or test market an investigational device before FDA approves it for commercial distribution, commercialize it beyond recovery of specified costs, or represent that it is safe or effective for the investigational purpose.

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.

statement: The Act prohibits any person from advertising or marketing a medicine or allied substance without a marketing authorisation issued by the Authority, so a device may not be advertised in Zambia before it is authorised. ZAMRA's fee schedule carries separate heads for advertising medicines to the general public (ZMW 5,000), promotion to health care professionals (ZMW 1,000) and exhibition of medicines at a public event (ZMW 2,000), under the heading 'Advertising and Promotion of Medicines and Allied Substances'.

statement: The Act's advertising controls are defined in relation to medicines: 'advertisement', in relation to any medicine, means written, pictorial, visual or other descriptive matter, or a verbal statement or reference, appearing in any publication, on television or film, distributed to members of the public, or otherwise brought to the notice of members of the public, intended to promote the sale of that medicine, and section 40 governs the advertisement of medicines. MCAZ's Strategic Plan accordingly lists 'Control of promotion and advertising of medicines' among the Authority's overall functions. The section 38(1)(b) regulation power could in principle be used to restrict the advertising of a controlled device, but no such restriction has been made in either the Condom or the Glove Regulations, and no device advertising guideline, approval or fee exists.