The article highlights the aspects related to the information to be included in the application an interested party should submit.
Table of content
The Medical Device Authority (MDA), a Malaysian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to applications for medical device advertisement approval.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance to them.
The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
In particular, the document describes in detail the information to be included in the applications.
The guidelines are structured into several sections, each addressing different aspects of medical device advertising.
These include the application process, content requirements, submission instructions, payment details, and authorization procedures.
Application Process
The document contains an application form for medical device advertisement, adhering to the Medical Device (Advertising) Regulations 2019.
The checklist includes requirements such as a completed application form, a copy of the proposed advertisement, а fee payable by the applicant, an appointment/authorization letter from the manufacturer, and translated copies of the advertisement if in languages other than Bahasa Malaysia and English.
Supporting documents for content featuring testimonials, endorsements, test trials, or scientific references are also mandated.
Applicant Details
The application form requires comprehensive information about the applicant, including their name, designation, contact details, company registration number, and address.
The applicant is responsible for the advertisement and must declare their role, which could be as an establishment, manufacturer, authorized representative, distributor, importer, advertising agency, or service provider.
Medical Device and Advertisement Details
According to the guidelines, the medical device’s name, brand, registration number, and establishment license number should also be provided.
For the advertisement, details such as previous approvals, content type (text, visual, audio), proposed media (broadcast, internet/social media, printed, external), and languages used are required.
For content including testimonials or endorsements, supporting documents must be provided.
Attestation and Declaration
The applicant must attest and declare compliance with the Medical Device (Advertising) Regulations 2019 and the registration of the medical device under Section 5 of Act 737.
A clear statement of the accuracy and truthfulness of the information and documents provided is required, acknowledging that any false declarations are punishable by law.
Submission and Payment Instructions
Submission instructions provided in the guidance are quite detailed, emphasizing that applications must be complete, supported by a checklist, and submitted in hard copy.
The format for the proposed advertisement is specified (e.g. MP4 or . AVI for videos), with a maximum size limit for documents.
The processing fee must be paid via bank transfer, and instructions on payment details, including the non-refundability of the processing fee, are also provided in the guidelines.
Letter of Authorisation
The document includes a template for a Letter of Authorisation, which must be printed on the manufacturer or authorized representative’s letterhead.
This letter grants permission to the applicant to prepare and submit advertisement applications on behalf of the manufacturer or authorized representative.
It outlines the responsibility to comply with the Medical Device Act 2012 (Act 737) and acknowledges the consequences of non-compliance.
Finally, the document provides contact information for the Medical Device Authority, and Ministry of Health Malaysia, including address, phone, and fax numbers, and the website.
Conclusion
In summary, the guidelines provide a detailed and structured approach to the advertisement of medical devices in Malaysia.
They emphasize the need for accuracy, compliance, and thoroughness in the application process.
The document reflects a comprehensive regulatory framework designed to ensure that medical device advertisements are responsible, truthful, and in line with national health policies and regulations.
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