Decree No. 342/2025/ND-CP, which took effect on 15 February 2026, updates the rules regarding the advertising of medical devices1. Importantly, Article 32 of this Decree explains that the regulations regarding the advertising of medical devices are now implemented in accordance…
Increasingly, collaboration with influencers is being used as part of marketing activities to increase awareness of medical devices and strengthen dialogue with end users. Although influencer marketing holds great potential when it comes to communicating medical devices in a way…
Guidance entitled Advertising therapeutic goods on social media was updated on 5 November 2025 to include comprehensive advertising guidelines for social media marketing tools/platforms/channels and to add new resource links1. The purpose of this guidance is to help advertisers understand…
An Announcement has been issued by the Ministry of Public Health concerning advertisements for medical devices in national academic exhibitions or international or academic conferences that do not require permission (B.E. 2568)1. The Announcement defines ‘national or international academic exhibition’…
The Therapeutic Goods (Restricted Representations – Contact Lenses and Spectacle Lenses) Permission 2025 took effect on 1 October 20251. As a result, a representation that refers to correcting a refractive error of the eye or controlling the progression of myopia…
The Therapeutic Goods (Restricted Representations—Wound Dressings) Permission 20251 – an instrument made under section 42DK of the Therapeutic Goods Act 1989 – came into effect on 19 July 2025. For subsection 42DK(1) of the Therapeutic Goods Act 1989, the restricted representations specified…
Since 1 March 2025, the medical device advertisement application process is being conducted entirely online via Google Forms1,2. This initiative aims to increase efficiency, streamline delivery, and improve overall workflow. Advertisement approval letters will only be sent directly to applicants…
A fourth revision of the Guide on the Implementation of the Medical Device Sales, Advertising and Promotion Regulation (TCS-KLVZ-08) was published on 30 December 20241. Topics addressed in the update include: issuance of warranty certificates; technical service responsibilities; qualification…
On 30 September 2024, the third revision of the Guideline on the Implementation of the Regulation on the Sale, Advertising and Promotion of Medical Devices was published1. Issues regarding the technical service activities and warranty certificate within the scope of…
Introduction The topic of regulatory advertising and promotion encompasses the laws, regulations, and guidelines that control how companies market and advertise their medical devices and/or services. It is a niche and specialised area, which requires a unique blend of regulatory…
On 6 September 2024, the Department of Pharmaceuticals issued a Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 20241 to all medical device industry associations; strict compliance with this Code is expected by all member companies. All medical device…
The Food and Drug Administration has released for public comment a revised draft guidance for industry entitled, Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers1,2. When finalised, this revised draft guidance will describe the Agency’s current thinking…
Updated versions of the information and recommended guidelines for the advertising of medical devices and in vitro diagnostic medical devices (IVDs) have been published1 to reflect changes made by recent amendments to the legislation: UST-42 version 1, Sponsoring and…
From 1 December 2023, all completed advertisement applications must be sent via email to advertisement@mda.gov.my1. Applications received in hard copy will no longer be processed. Applications must include all the requested information, and a completed checklist form to confirm all…
A second revision of the Guide on the Implementation of the Medical Device Sales, Advertising and Promotion Regulation (TCS-KLVZ-08) was published in January 20241. Topics covered include: the application, authorisation certificate, employment certificate and identity card; education, examination, certificate…
Consultation has been held on draft Measures for the Review and Management of Advertisements for Drugs, Medical Devices, Health Foods, and Formula Foods for Special Medical Purposes1. These updated Measures have been proposed to strengthen the supervision and management of…
Regulatory essentials Regulatory authority Directorate of Medicines and Pharmacy (Direction du Médicament et de la Pharmacie, DMP) Classification system Medical devices: Classes I, Im (measuring), Is (sterile), IIa, IIb, III In vitro diagnostic reagents: None Registration requirements Application form, administrative…
The Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (2021 Code) came into effect on 1 January 2022, repealing and replacing the 2018 version1. A transition period applies until 30 June 2022, during which time advertisers may comply with either…
Regulatory authority The Food and Drugs Authority (FDA) is the government agency responsible for medical device regulation in Ghana in addition to cosmetics, household chemical substances, food, drugs, herbal medicinal products, tobacco, blood and blood products, and the regulation of…
Introduction The VietNamese healthcare market is in a time of change as the government seeks to invest in aging facilities and equipment while enticing foreign manufacturers with new, friendlier regulations. Seen as a high potential market, only specific medical devices…
On 25 November 2021, the Department of Medical Devices published four guidelines1 on the regulation of the advertising of medical devices and in vitro diagnostic medical devices (IVDs): UST-39, Regulation of advertising for medical devices and diagnostic medical devices…
Following an 18-month period of stakeholder consultation, the Therapeutic Goods Administration has issued the Therapeutic Goods Advertising Code 2021, which took effect on 1 January 20221. Advertisers have until 30 June 2022 to transition from the current Code to the…
Comments were accepted until 2 January 2022 on a draft Law of Ukraine ‘On Medical Devices’, which applies to medical devices, in vitro diagnostic medical devices and active implantable medical devices1. The purpose of the draft Law is to: …
Introduction As the standard of living continues to rise in Thailand and around the world, people continue to demand better healthcare. Better healthcare can come in many forms, from early detection diagnostics utilising artificial intelligence to wearable technology. Heavily relying…
In an effort to unify and streamline regulations on the management of medical devices in Vietnam, the Ministry of Health (MoH) has drafted a new Decree intended to replace the three current Decrees on medical device management (Decree No. 36/2016/ND-CP…
Guideline MDA/GL/04 (March 2021, first edition) specifies the requirements for advertisements of medical devices that require approval and for those where no approval is required1. The following materials are controlled through self-regulation; they must comply with the requirements set out…
Taiwan’s new Medical Devices Act1, which formally separates the regulation of medical devices from pharmaceuticals, is set to take effect on 1 May 2021. The Act defines medical devices as: ‘instruments, machines, apparatus, materials, software, reagents for in vitro…
With a view to implementing the Medical Devices Act, which was promulgated on 15 January 2020, the Ministry of Health and Welfare has proposed Enforcement Rules of Medical Device Act to provide further details1. The provisions of the draft Enforcement…
The requirements that apply to the advertisement of medical devices are clarified in a new guidance document from the Medical Device Authority (MDA/GD/0032)1. An advertisement is defined as: ‘Any statement, pictorial representation or design, by means of any document…
On 20 May 2020, the Medical Device Authority announced a transitional period of 18 months1 for the implementation of the Medical Device (Advertising) Regulation 2019. This Regulation came into operation on 1 July 2020 and the transition period runs from…
Introduction The Food and Drug Administration (FDA) has the authority to regulate medical device labelling and advertising of restricted medical devices1. Medical device companies can undertake promotional activities using labelling to advertise a device after the appropriate FDA clearance or…
Introduction Both Regulation (EU) 2017/745 on medical devices (MDR)1 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)2 include an identical Article 7 entitled ‘Claims’, which includes obligations (both positive and negative) in relation to labelling, instructions for…
The Medical Device (Advertising) Regulations 2019 have been published and come into operation on 1 July 20201. According to the Regulations, no-one may advertise any registered medical device without the approval of the Medical Device Authority. Any contravention of this…
In order to promote a reliable supply, and safe management, of medical devices, the Ministry of Food and Drug Safety has proposed two changes1 to the Enforcement Regulation of the Medical Devices Act. Firstly, when supply interruptions become predictable for…
The Ministry of Food and Drug Safety of the Republic of Korea has proposed amendments1 to the Medical Devices Act to address certain limitations identified during operation of the Act. The proposed revisions are as follows: Clarification of the…
Market overview It is estimated that local manufacturers only meet 10% of the market demand for medical devices in Vietnam, while 90% of medical devices are imported, especially advanced technology like diagnostic imaging equipment. Local manufacturers have only been able…
Introduction Around the world, medical devices have become an integral part of modern healthcare and even daily life. These advancements are largely due to an influx of innovative, digital technology that has changed the medical device environment. Telephones, watches and…
On 1 January 2019, the Therapeutic Goods Advertising Code (No 2) 2018 took effect1, superseding the Therapeutic Goods Advertising Code 2015. The Therapeutic Goods Administration held consultations on the draft Therapeutic Goods Advertising Code 2018 and associated guidelines between March…
Decree No 2018-864 of 8 October 2018 relating to the practices of presentation, information or promotion for health products and any associated services was published in the Official Journal on 9 October 20181. The Decree came into force the day after…
Regulatory authority The Competent Authority for medical devices in Zimbabwe is the Medicines Control Authority of Zimbabwe (MCAZ). This Agency is responsible for, inter alia, control and assessment of the quality of medical devices, and issuing registrations and distributor registration…
Towards the end of June 2018, a draft Amendment of the Medical Device Supervision and Administration Regulations was circulated for public comment1. These proposed changes are quite extensive: 12 articles are proposed for addition, two for deletion and 39 for…
On 29 June 2018, the Therapeutic Goods Advertising Code 2018 was published in Australia’s Federal Register of Legislation1. It will take effect on 1 January 2019 and on this same date the 2015 Code will be repealed. The primary changes…
Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) has issued new guidelines relating to digital advertising campaigns (e.g. website banners, videos, social media posts) for medical devices and other healthcare products1. The guidelines cover both proprietary digital content…
New guidance has been published for manufacturers, packers and distributors of medical products, including medical devices, on how the Food and Drug Administration (FDA) evaluates their medical product communications that present information that is not contained in the FDA-required labelling…
A rule concerning the preliminary review of medical device advertisements came into force in the Republic of Korea on 28 December 20161. The rule specifies the requirements for medical device advertisements to be reviewed by the Ministry of Food and…
Three consultations on regulatory changes that could affect the medical device industry were held in Australia in the final quarter of 2016: Regulatory framework for advertising therapeutic goods1. Comments were solicited on the appropriate body or bodies for the handling…
Guidance has been drafted1,2 on how the Food and Drug Administration (FDA) evaluates a company’s medical product communications, including promotional materials, that present information that is not contained in the FDA-required labelling but that may be consistent with the FDA-required…
Towards the end of 2017, the Ministry of Food and Drug Safety (MFDS) in the Republic of Korea issued a number of proposed regulatory amendments for public comment; details are as follows: Proposed amendments to the Regulations on Approval, Notification…
Regulatory authority After its independence in 1947, the Pakistan Government adopted India’s Drugs and Cosmetics Act, 1940. However, owing to the Act’s limitations, the Government of Pakistan enacted a completely new Drugs Act in 1976, which was administered by the Drug…
A number of changes will be made to the Australian regulatory framework for the advertising of therapeutic goods over the next two years1. These changes, which reflect the recommendations of the Review of Medicines and Medical Devices Regulation on reforms…
