Can condoms be bought and sold like ordinary goods? What are the specific technical standards for male condoms?
Are condoms bought and sold like regular goods?
Based on the provisions of Article 42 of Decree 98/2021/ND-CP, the regulations are as follows:
Buying and selling medical devices without having to meet conditions and carrying out procedures for announcing eligibility to buy and sell
1. Medical devices of types B, C, D on the list of medical devices issued by the Minister of Health can be bought and sold like regular goods.
2. The purchase and sale of medical devices according to the provisions of Clause 1 of this Article do not have to meet the conditions prescribed in Article 40 of this Decree and do not have to announce eligibility to buy and sell according to the provisions of Article 41 of this Decree but must still meet the conditions for preservation, storage, and transportation according to the regulations of the medical device owner.
Referring to the regulations in Article 4 of Circular 05/2022/TT-BYT as follows:
List of medical devices of types B, C, D that can be bought and sold like regular goods according to the provisions of Clause 1, Article 42 of Decree 98/2021/ND-CP
1. Personal blood pressure monitors.
2. Blood oxygen saturation monitors (SpO2) that use battery-operated fingertip clips.
3. Nasal aspirators for children.
4. Electronic thermometers, infrared thermometers.
5. Medical devices used for personal blood glucose measurement: blood glucose meters, blood sampling pens, test strips, lancets, calibration solutions, control solutions.
6. Nebulizers.
7. Personal medical bandages and gauze.
8. Artificial tears classified as medical devices.
9. Condoms.
10. Contraceptive film (non-drug-containing).
11. Vaginal lubricants classified as medical devices.
12. Electric hot and cold packs.
13. In vitro diagnostic medical devices for self-testing classified as type B.
14. In vitro diagnostic medical devices for self-testing for HIV, SARS-CoV-2.
According to the above regulations, condoms are in the list of medical devices that can be bought and sold like regular goods.
Are condoms bought and sold like regular goods? What are the specific technical standards for male condoms?
What conditions must a condom business meet?
Based on the provisions of Article 40 of Decree 98/2021/ND-CP, the regulations on the conditions for a condom business are as follows:
(1) There must be at least 01 technical staff member with a college degree or higher in engineering, medical, pharmacy, chemistry, biology, or medical equipment engineering or have a college degree or higher in a major that is suitable for the type of medical device that the business trades in.
(2) There must be storage and transportation facilities that meet the following minimum conditions:
Storage facilities:
- Have a suitable area for the types and quantities of medical devices to be stored,
- Ensure ventilation, dryness, cleanliness, and no proximity to sources of pollution,
- Meet other storage requirements of the medical device according to the user manual.
Transportation facilities for medical devices from the business to the delivery location must be suitable for the type of medical device that the business trades in.
If there are no storage or transportation facilities for medical devices, there must be a contract with a competent facility for the storage and transportation of medical devices.
What are the specific technical standards for male condoms?
Based on Article 4 of the Regulations on technical standards for contraceptive devices used in the national target program on population and family planning issued with Decision 714/QD-BYT in 2010, the specific technical standards for condoms are as follows:
Male condoms
1. Applicable standards
Apply ISO 4074-2002 and WHO 2003 standards;
2. Material: natural latex
3. Size:
- Length: not less than 170 mm
- Width: 49 ± 2mm or 52 ± 2mm
- Thickness: 0.065 ± 0.015mm
4. Volume and bursting pressure
(Before and after aging: aging at 168 ± 2 hours at a temperature of 70 ± 2ºC)
- Bursting 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 from 50mm to 54mm.
- Bursting pressure: not less than 1.0 kPa.
5. Lubricant: condoms are lubricated with silicone solution
- Viscosity from 200 - 350 CS.
- Lubricant content (including any flavoring powder): 550 ± 150 mg.
- The lubricant must be non-toxic and non-allergenic.
6. Color and transparency: translucent and colorless
7. Packaging
7.1. Individual packaging:
- Each condom must be individually packaged in an aluminum foil. Each package has a V-notch or pre-cut edge for easy tearing.
- Size: square type from 5.5-6cm or rectangular type from 3cm x 6.5-6.9cm.
- Packaging tightness: airtight, no leakage.
7.2. Condom storage box
7.2.1. Free distribution box
- Small box: each box holds 10 (ten) individually packaged condoms.
- Intermediate box: each box holds 20 (twenty) small boxes, a total of 200 condoms.
- Corrugated cardboard box: 25 (twenty-five) intermediate boxes, a total of 5,000 condoms packaged in 5-layer corrugated cardboard boxes.
7.2.. Condom distribution box for district-level towns
- Small box: each box holds 04 (four) or 03 (three) individually packaged condoms.
- Intermediate box: each box holds 36 (thirty-six) or 48 (forty-eight) small boxes.
Each intermediate box holds 144 individually packaged condoms.
- Corrugated cardboard box: 25 (twenty-five) intermediate boxes, a total of 3,600 condoms packaged in 5-layer corrugated cardboard boxes.
Male condoms must meet the above criteria.
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