What age is eligible to buy condoms in Vietnam?

What age is eligible to buy condoms in Vietnam?

Pursuant to Article 42 of the Decree 98/2021/NĐ-CP stipulating trading in medical devices without satisfying eligibility requirements and following procedures for declaration of eligibility for medical device trading as follows:

1. Class-B, C, D medical devices included in the list of medical devices promulgated by the Minister of Health shall be traded as normal goods.

2. Establishments trading in the medical devices prescribed in Clause 1 of this Article shall not be required to satisfy eligibility requirements laid down in Article 40 of this Decree and follow procedures for declaration of eligibility for medical device trading as prescribed in Article 41 of this Article but must still meet the storage and transport requirements as prescribed by product owners.

Pursuant to Article 4 of the Circular 05/2022/TT-BYT stipulating list of class B, class C, and class D medical devices purchased and sold as common commodities mentioned under Clause 1 Article 42 of Decree 98/2021/ND-CP as follows:

...

6. Nebulizers.

7. Medical tape, gauze pads.

8. Artificial tears classified as medical devices.

9. Condoms.

10. Vaginal contraceptive film (contains no drugs).

...

As regulations above, condom can be sold as common commodities. There is no age limit to buy condoms.

Therefore, people at any age can buy condoms in Vietnam.

What are requirements for trading condoms in Vietnam?

Pursuant to Article 40 of the Decree 98/2021/NĐ-CP stipulating requirements for trading in Class-B, C, D medical devices as follows:

To be permitted to trade in Class-B, C, D medical devices, an establishment must:

1. Have at least 01 employee who has an associate degree, or higher, in technology, medicine, pharmacy, chemistry, biology or medical devices, or an associate degree, or higher, suitable for the medical devices sold by the establishment.

2. Have warehouse and vehicles that satisfy the following requirements:

a) The warehouse must:

- have an area suitable for the categories and quantities of medical devices stored therein;

- be well ventilated, dry and clean, and separated from sources of pollution;

- satisfy storage requirements for the medical devices laid down in their user manuals.

b) The vehicle used for transporting medical devices to buyers must be suitable for categories of such medical devices;

A trading establishment that does not have a warehouse or vehicle may sign a contract with a qualified storage or transport service provider.

3. Requirements for trading in medical devices that contain narcotic substances or precursors:

a) The chief technician has a bachelor’s degree in medical devices, medicine, pharmacy, pharmaceutical chemistry or biology.

b) The trading establishment must have a warehouse that satisfies the requirements laid down in Article 7 of the Government’s Decree No. 80/2001/ND-CP dated November 05, 2001.

c) There is an inventory monitoring system for medical devices containing narcotic substances and precursors.

As regulations above, shops trading condoms must have at least 01 employee who has an associate degree, or higher, in technology including condoms. In addition, the shops must have warehouse and vehicles that satisfy above requirements.

What are technical requirements for condoms in Vietnam?

Pursuant to Article 4 of the Regulation on technical standards for contraceptives used in the national target program on population and family planning promulgated together with Decision 714/QD-BYT in 2010, specific technical requirements for condoms are as follows:

1. Applicable standards

Apply standards of ISO 4074-2002 and WHO 2003;

2. Material: natural latex

3. Size:

- Length: not less than 170 mm

- Width: 49 ± 2mm or 52 ± 2mm

- Thickness: 0.065 ± 0.015mm

4. Explosion volume and pressure

(Before aging and after aging: at 168 ± 2 hours with temperature 70 ± 20C)

- Explosion volume: not less than 16 liters (16dm3) for condoms with a width of less than 50mm; not less than 18 liters (18dm3) for condoms with a width of 50mm to 54mm.

- Blast pressure: not less than 1.0 kPa.

5. Lubricant: condoms are lubricated with silicone solution

- Viscosity from 200 - 350 CS.

- Lubricant content (including flavoring powder): 550 ± 150 mg.

- Non-toxic, allergen-free lubricant.

6. Color and transparency: translucent and colorless

7. Packaging

7.1. Individual bags:

- Each condom must be packaged in a single aluminum foil bag. Each pack has a V-knife or pre-cut at the edge for easy tearing.

- Size: square type from 5.5-6cm or rectangular type from 3cm x 6.5-6.9cm.

- Packing tightness: sealed, not tampered.

7.2. Condom box

7.2.1. Free condom box

- Small box: each box contains 10 (ten) condoms packed in individual bags.

- Intermediate box: each box contains 20 (twenty) small boxes, including 200 condoms.

- Cardboard carton: 25 (twenty-five) intermediate boxes of 5,000 condoms packed in a 5-layer corrugated cardboard box.

7.2.. Social marketing condom box

- Small box: each box contains 04 (four) condoms or 03 (three) condoms packed in individual bags.

- Intermediate box: each box contains 36 (thirty-six) small boxes or 48 (forty-eight) small boxes.

Each intermediate box contains 144 condoms packed in individual bags.

- Cardboard carton: 25 (twenty-five) intermediate boxes of 3,600 condoms packed in a 5-layer corrugated cardboard box.

Above are technical requirements for condoms in Vietnam.

Best regards!