Our company is planning to import and distribute condoms in Vietnam. The packaging process is expected to be carried out at a factory in Hai Duong, which currently manufactures boots and abdominal belts. What legal conditions must our company meet, and what types of permits are required to legally conduct this activity in Vietnam?
Answer
Regarding issues related to importing, trading and packaging condoms, please refer to the following:
1. Conditions for Importation and Trading of Condoms
Condoms are classified as Class B, C, or D medical devices and are traded as ordinary goods in accordance with Circular 05/2022 issued by the Ministry of Health.
In the event that your enterprise imports condoms into Vietnam for repackaging, the following customs documents must be prepared to obtain import permission:
- Customs declaration or equivalent substitute documents;
- Relevant documents, including: contracts, commercial invoices, packing lists, bills of lading, certificates of origin;
- Import license for medical devices;
- Certificate of Free Sale (CFS);
- Technical documents and user manuals;
- Quarantine certificate (if applicable).
(Article 24 of the Customs Law 2014, Article 37 of the Law on Foreign Trade Management 2017)
Pursuant to Decision No. 27/2018/QĐ-TTg on the Vietnamese economic sector classification system, there is no specific classification for the packaging service of this particular product. However, relevant standards related to condoms may be applied during the packaging and distribution process of this product in the market.
2. Packaging Requirements for Condoms
Pursuant to the applicable regulations, investors are required to strictly comply with the legal standards and requirements related to product packaging and labeling. Specifically, the following must be observed:
a. Standards for Individual Packaging:
- Packaging Material: Each condom must be individually packaged using aluminum foil.
- Design: The packaging must have pre-cut edges for easy opening.
- Size:
For square packaging: Dimensions must range from 5.5 to 6 cm.
For rectangular packaging: Dimensions must be 3 cm x 6.5 - 6.9 cm.
- Sealing: The packaging must be airtight, ensuring no air leakage or seepage.
(Article 4, Decision No. 714/QĐ-BYT)
b. Product Labeling Information:
The product label must include the following minimum required information:
- Name of the product;
- Name and address of the entity responsible for the product;
- Country of origin;
- Other information as required by applicable laws.
(Decree No. 43/2017/NĐ-CP and Decree No. 111/2021/NĐ-CP)
3. Requirements for the Condom Packaging Facility
Currently, the company’s manufacturing facility in Hải Dương specializes in the production of rubber boots and waist belts. However, condom packaging falls under Industry Code 8292 (Packaging Services), which is classified as a distinct business activity from the company’s existing registered business lines.
If the company has not yet registered this industry code, it must amend its business registration certificate to include this activity.
Business Registration Amendment Cerificatate, consist of:
- Notification of changes to business registration;
- Resolution or decision of the Board of Members (for a limited liability company) or the General Meeting of Shareholders (for a joint-stock company).
(Article 56, Decree No. 01/2021/NĐ-CP)
To proceed with the condom packaging business, the company must ensure compliance with legal requirements regarding business registration in the relevant industry sector. Adding Industry Code 8292 to the company’s business registration is a mandatory requirement if it has not yet been included.
4. Conditions for Circulation of Packaged Condoms
a. Conditions for Circulation
Condoms are classified as medical devices; therefore, to be legally circulated in the market, the product must meet the following conditions:
- Circulation number and related documents: The product must have a circulation number, a registration number, a circulation registration certificate, or an import license in accordance with regulations on the management of medical devices;
- Product labeling: The product label must provide complete information as required by current legal regulations on product labeling;
- User manual: The product must be accompanied by a user manual in Vietnamese, in compliance with regulations applicable to medical devices.
(Article 22 of Decree 98/2021/NĐ-CP)
b. Regulations on Storage and Transportation
- Storage facilities:
+ The storage area must be suitable for the quantity of products to be stored;
+ The storage area must ensure ventilation, dryness, cleanliness, and must not be located near sources of pollution.
(Point a, Clause 2, Article 40 of Decree 98/2021/NĐ-CP)
- Transportation and distribution means:
+ The means of transportation must be appropriate for the type of medical device being transported;
+ If the company does not have its own transportation means, it must enter into a contract with a transportation unit that meets the required legal conditions.
(Point b, Clause 2, Article 40 of Decree 98/2021/NĐ-CP)
The legal regulations on circulation conditions, storage, and transportation aim to ensure that condoms are legally circulated, remain stable, and maintain their quality when reaching consumers.
Conclusion
To legalize the packaging and distribution of condoms, businesses must undertake the following procedures and prepare the necessary legal documents:
1. Customs documentation:Obtain an import license for condoms in accordance with applicable regulations;
2. Business sector registration update:If the business has not yet registered under industry code 8292 – Packaging Services, it must update this industry in its business license.
Additionally, businesses must ensure compliance with packaging, storage, and transportation standards to meet legal requirements and achieve lawful market circulation. Full compliance with these regulations not only enables businesses to operate legally but also ensures their credibility and the quality of their products.
