Procedures for Obtaining a Certificate of Confirmation of Advertising Content for Medical Equipment in 2021
The need for product advertising and promotion is increasingly popular to bring products to customers, including medical equipment. With the development of scientific and technological progress, many new medical devices have been born. However, to reach end-users, product advertising plays a crucial role. Medical equipment is a product that directly affects human health when used and must have clear instructions for use. Therefore, the advertising content of medical equipment must be censored before advertising to ensure that the product reflects the correct quality, function, and does not affect the health of consumers. So what are the conditions, dossier components, and procedures for applying for a certificate of confirmation of advertising content for medical equipment?
Let's find out the procedures for issuing a Certificate of Confirmation of Advertising Content for Medical Equipment with Thien Di.
1. Legal Basis for Granting a Certificate of Confirmation for Medical Equipment Advertisement Content
The following laws and regulations must be followed in order to obtain a Certificate of Confirmation for Medical Equipment Advertisement Content:
- Law on Advertising 2012
- Decree 181/2013/NĐ-CP
- Circular 09/2015/TT-BYT
2. Medical Equipment in Vietnam
2.1. Definition of Medical Equipment
According to Decree No. 36/2016/NĐ-CP and its amendments in Decree No. 169/2018/NĐ-CP, medical equipment is defined as devices, instruments, materials, implants, in vitro tests and calibrators, software, and other items that meet specific requirements. These requirements include:
- Being used individually or in combination as directed by the owner of the medical equipment.
- Serving human health purposes, including:
- Diagnosing, preventing, monitoring, treating, and alleviating diseases and injuries.
- Testing, replacing, adjusting, and supporting surgical and physiological processes.
- Supporting or sustaining life.
- Controlling conception.
- Sterilizing other related equipment.
- Providing necessary and useful information for testing, diagnosing, monitoring, and treating patients by examining and testing samples from the human body.
Medical equipment does not work through pharmacological or immunological mechanisms, nor does it undergo metabolism in or on the human body. If such mechanisms are used, they are only for supportive purposes and must comply with specific regulations.
2.2. Certificate of Confirmation of Medical Equipment Advertisement Content
The Certificate of Confirmation of Medical Equipment Advertisement Content is a legal document issued by a competent state agency to organizations and individuals that allows them to advertise medical equipment. Since medical equipment is a special category of product, in addition to complying with the general advertising law and regulations, advertising medical equipment must also follow specific regulations.
3. Penalties for not performing the content confirmation procedure for medical equipment advertising:
According to Decree 28/2017/ND-CP, advertising medical equipment without permission will be subject to an administrative penalty:
Fine from 15,000,000 VND to 20,000,000 VND for advertising products, goods, and special services without having the content confirmed by the competent state agency before advertising as prescribed.
Additional penalties may also apply, such as: Forced removal, termination, or deletion of advertising.
4. Conditions for performing the content confirmation procedure for medical equipment advertising:
- The language, writing, and images in the advertisement must be concise, common, and in compliance with Article 18 of the Advertising Law.
- The smallest font size in the advertising content must be large enough to be readable under normal conditions and must not be smaller than the equivalent of font size Vntime or Times New Roman 12 on A4 paper.
- Have a business registration certificate for the business line of trading medical equipment or manufacturing medical equipment.
- Have an import license for medical equipment for imported products or a certificate of registration for circulation of medical equipment for domestic products.
- Have a complete set of documents as prescribed.
- The unit requesting confirmation of the advertising content must be the unit named on the certificate of registration for circulation for domestically produced products or the import license for imported products, or the representative office in Vietnam of the unit named on the import license, or a legal entity authorized in writing by the unit named on the certificate of registration for circulation for domestically produced products or the import license for imported products.
5. Principles for Confirming the Content of Medical Equipment Advertising
The content of medical equipment advertisements must be consistent with the Certificate of Free Circulation Registration for domestically produced equipment or the Import License for imported equipment.
Medical equipment advertisements must include the following information:
- Name, type, manufacturer, and country of origin of the medical equipment;
- Functions, effects, instructions for use, and storage conditions (if applicable);
- Name and address of the organization or individual responsible for bringing the product to market.
6. Documents Required for Medical Equipment Advertisement Content Confirmation Procedure
To proceed with the medical equipment advertisement content confirmation procedure, the Enterprise needs to prepare the following complete set of documents:
- Written request for advertisement content confirmation in accordance with regulations;
- Business registration certificate of the enterprise or establishment license of the foreign trader's representative office;
- Medical equipment import license or medical equipment registration certificate.
- Advertisement Content for Confirmation:
- For advertisements on newspapers and television, there must be 1 recorded copy of the expected advertisement content on a CD/DVD, audio CD, and 3 soft copies of the expected advertisement script, clearly describing the content, expected advertising media, visuals (for television), voice, and music;
- For advertisements on media other than newspapers and television, there must be 3 printed color copies of the expected advertisement layout and a soft copy of the expected advertisement content;
- For advertisements through seminars, conferences, or events: In addition to the above documents, the following documents are required: advertising samples used in the program that have been approved by the competent authority and are still valid (if the advertising sample has been approved for content), the program must clearly state the report name, time (day/month/year), and venue (specific address); the content of the report and the documents presented to the participants; a list of the names, scientific titles, and professional qualifications of the speakers (speakers must have professional qualifications and experience relevant to the field of products, goods, and services advertised).
- Product label sample or product label sample that has been approved by the competent health authority in cases where the law requires the product label to be approved by the competent health authority.
- Number of Document Sets: 01 set
7. What to keep in mind when preparing a file for confirmation of medical equipment advertising content?
Documents in English must be translated into Vietnamese and accompanied by the original English documents. The Vietnamese translation must be stamped and certified by the entity requesting confirmation of the advertising content.
Documents in a foreign language other than English must be translated into Vietnamese and accompanied by the original foreign language documents. The Vietnamese translation must be notarized in accordance with legal regulations.
Documents in the file must be clearly printed and arranged in the prescribed order.
Documents in the file requesting confirmation of advertising content must be valid and must be certified copies or copies stamped by the entity requesting confirmation of advertising content. The documents in the file must have the seal or stamp of the entity requesting confirmation of the advertising content.
The advertising content sample must be presented on A4 paper size. The layout of large outdoor advertising forms can be presented on A3 paper size or other paper sizes and must clearly indicate the size ratio compared to the actual size.
8. Authority to grant licenses
The Department of Medical Equipment and Facilities issues certificates of confirmation of advertising content for medical equipment (under the authority of the Minister of Health).
9. Forms of Medical Device Advertising Requiring a License
The following forms of medical device advertising require a license:
- Website advertising
- YouTube advertising
- Advertising on means of transport
- Television advertising
- Newspaper advertising
- Advertising on billboards
- Outdoor advertising
10. Issuance Time for Medical Device Advertising Content Confirmation Certificate
Within 10 working days from the date of receiving a complete and valid application, the competent state agency shall issue a certificate of confirmation of advertising content.
11. Cases for Re-issuing a Certificate of Confirmation for Medical Equipment Advertising Content
11.1 Cases Requiring Re-issuance of a Certificate of Confirmation for Medical Equipment Advertising Content
The following cases require re-issuance of a Certificate of Confirmation for Medical Equipment Advertising Content:
- The advertising content confirmation requestor amends or supplements the application dossier but does not follow the request for amendment or supplementation from the dossier receiving agency.
- The advertising content confirmation requestor amends or supplements the application dossier but does not follow the deadline for cases where the application dossier is invalid. Within 05 working days from the date of receiving the application dossier according to the incoming document receipt stamp of the dossier receiving agency, the dossier receiving agency will issue a document requesting the unit to amend or supplement the dossier. The maximum time for the advertising content confirmation requestor to complete the dossier according to the request is 90 days from the date of receiving the amendment or supplementation notice from the dossier receiving agency. After this deadline, the advertising content confirmation request will be invalid.
11.2 Cases for Re-issuing a Certificate of Confirmation for Medical Equipment Advertising Content
- Re-issuing a Certificate of Confirmation for Medical Equipment Advertising Content in case of loss or damage.
- Re-issuing a Certificate of Confirmation for Medical Equipment Advertising Content in cases where the Certificate of Confirmation for Medical Equipment Advertising Content has expired.
- Re-issuing a Certificate of Confirmation for Medical Equipment Advertising Content in cases where the Certificate of Confirmation for Medical Equipment Advertising Content is still valid but there is a change in the name and address of the responsible organization or individual and the advertising content remains unchanged.
11.3 Cases where the Certificate of Confirmation for Medical Equipment Advertising Content Expires
- The import license or certificate of registration for circulation of products and goods expires.
- Products and goods are suspended from circulation or recalled.
12. Information Customers Need to Provide
- Notarized copy of the Certificate of Business Registration or Certificate of Investment Registration, Certificate of Establishment of a Representative Office of a Foreign Trader named on the Certificate of Confirmation of Advertising Content.
- Information about the medical device to be advertised.
- Advertising form/ advertising medium/ advertising location.
- Advertising script/ advertising market.
- Notarized copy of the import license for medical equipment or the certificate of registration for circulation of medical equipment.
13. How to obtain a medical equipment advertising license in Vietnam:
13.1. Application requirements:
- Notarized copy of the Business Registration Certificate.
- ISO management certificate for the factory or EC Certificate of Conformity.
- Product circulation license in the country of origin (Certificate of Free Sale).
- Product catalog (original and Vietnamese translation stamped by the company).
- 02 Market samples (advertisements in newspapers) (stamped and hung by the company).
- Distribution authorization or exclusive certificate.
13.2. Procedure for issuing a certificate of confirmation for medical equipment advertising content:
Step 1: The organization requesting confirmation of advertising content submits the application to the Department of Medical Equipment and Facilities, Ministry of Health.
Step 2: If the application is incomplete, within 05 working days from the date of receiving the application according to the receiving stamp of the receiving agency, the receiving agency will issue a written request for the organization to amend and supplement the application. The time for the organization requesting confirmation of advertising content to amend and complete the application as required is a maximum of 90 days from the date of receiving the written notice of amendment and supplementation from the receiving agency. After this deadline, the application for confirmation of advertising content will be invalid.
Step 3: Within 10 working days from the date of receiving all valid application documents according to the receiving stamp of the receiving agency, the competent state agency will issue a certificate of confirmation for the advertising content. If the certificate of confirmation for advertising content is not granted, the competent state agency must respond in writing and clearly state the reason for not granting it.
Step 4: For advertising through the form of seminars, conferences, and events:
a) At least 02 working days before conducting the advertising, the organization or individual with special products, goods, and services under the management of the Ministry of Health that have been granted a certificate of confirmation for advertising content for the form of seminars, conferences, and events by the competent authority of the Ministry of Health must notify in writing the form, time, and location of the advertising, accompanied by a copy of the certificate of confirmation of advertising content, the advertising sample or the approved advertising script to the Department of Health where the advertising is organized for inspection and verification if necessary;
b) In case of any changes in the location, time, and organization of seminars, conferences, and events compared to the content stated on the certificate of confirmation of advertising content, the organization or individual with advertising products, goods, and services must notify the local Department of Health.
14. Calculating the Fee for Issuing a Certificate of Advertising Content
14.1. Types of Costs to Consider When Applying for an Advertising License
When applying for an advertising license, businesses need to be aware of the following costs:
1. Cost of Building Advertising Content
Applying for an advertising license, or more precisely, applying for a certificate of advertising content, requires careful attention to the advertising content. The licensing authority will primarily consider whether the content complies with legal regulations.
Advertising content can be presented in written form, images (in the form of marketing materials), or videos and audio. If the advertising content is in the form of marketing materials, the business will need to budget for design costs. If the content is a video, the business will need to budget for scriptwriting and filming. In cases where the advertising content features models or actors, contracts will need to be drawn up with these individuals.
Depending on its financial capacity and needs, the business can develop advertising content that fits the budget it can afford.
2. Fee Payable to the State Authority for Advertising File Review
When submitting an application, businesses are responsible for paying the full advertising license application fee for file review. The file review fee varies depending on the type of product. If the application is submitted in person, the fee is paid at the same time as the application is submitted. If the business submits the application online, after the application is successfully submitted, the system will notify the business's account of the fee that needs to be paid. The application will only be processed once the payment is completed.
The payment of the state fee when applying for an advertising license can be made in various ways, including in person, through a bank, or through the national e-commerce payment system (KeyPay).
3. Cost of Using an Advertising License Application Service (If Any)
Businesses can either apply for an advertising license themselves or use the services of a specialized service provider. In this case, the business will have to pay a fee to the service provider, which will then take care of the entire advertising license application process and procedures on behalf of the business.
Thien Di is one of the leading providers of advertising license application services. When using our services, you will have to pay a fee, but that fee includes all state fees, consulting fees, and the cost of completing the procedures on behalf of the business. If the business does not have the resources to apply for an advertising license itself, it can consider this additional cost to receive support from a professional agency.
14.2. How to Calculate the Cost of Applying for an Advertising License
This article only discusses how to calculate the advertising cost for the fee payable to the state authority. The fee is calculated based on each advertising file. The number of advertising files a business has corresponds to the number of times the fee is paid.
According to regulations, each advertising sample corresponds to an application for confirmation of advertising content that must pay a review fee and confirmation fee as follows:
- Cases considered as a single application for confirmation of advertising content, including:
An advertising sample of a product, good, or service for one target audience;
An advertising sample of a product, good, or service for one target audience for multiple advertising formats (e.g., leaflets, posters, books, newspapers, etc.).
- Cases not considered as a single application for confirmation of advertising content, including:
Multiple different advertising samples of a product, good, or service for one target audience. In this case, each advertising sample is considered a separate application for confirmation of advertising content;
An advertising sample consisting of multiple different products, goods, or services for one target audience. In this case, each product, good, or service is considered a separate application for confirmation of advertising content.
15. Medical Equipment Advertising Content Certificate Issuance Procedures Service by Thien Di
- Consulting on procedures and legal issues related to the Medical Equipment Advertising Content Certificate Issuance procedure.
- Receiving documents from clients.
- Drafting complete and comprehensive documentation.
- Submitting the application to the competent authority.
- Accompanying clients during the file review and site inspection process.
- Receiving the results and delivering the originals to the client.
16. Reasons to choose Thiên Di's services:
Enthusiastic and timely customer support in all situations.
Our team consists of:
- Experienced and professional experts and staff.
- Regularly updated on new regulations and policies.
- Continuously trained to improve professional skills and work experience.
- Capable of handling high work pressure.
- Always dedicated to self-improvement and professionalism, aiming for absolute customer satisfaction.
16.1. Human Resources
Human resources are the key to the success of any business. Therefore, Thien Di always focuses on building and developing a professional, serious, and customer-friendly human resource team - which has been the compass for our success over the past time.
Thien Di provides services for medical equipment import procedures, medical equipment classification services, application for medical equipment import licenses, import licenses for medical equipment, etc. in Vietnam. Currently, we provide this service in most provinces and cities across the country, completing the application and procedures on behalf of clients to submit to state agencies, so clients will not have to spend time doing administrative procedures.
16.2. Additional services:
In addition to consulting on import license procedures for medical equipment, Thiên Di also offers a wide range of other services, including:
- Business registration and licensing
- Food safety certification
- Cosmetic registration
- Animal feed and aquatic feed registration
- Intellectual property registration
- Consulting on advertising permits
- Consulting on Free Sale Certificates (CFS)
- Health certificate application
- Contact us today to learn more about our services or to request a free consultation.
Contact Info:
THIEN DI TRADING SERVICES COMPANY LIMITED
Address: No. 36 Street A4, Ward 12, Tan Binh District, Ho Chi Minh City
Hotline: 0981317075
Phone: 028.6293 9377
Email: info@luatthiendi.com
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