Circular No. 31/2017/TT-BYT issues the List of products and goods that may cause safety risks within the scope of management of the Ministry of Health, including groups such as finished pharmaceutical products, vaccines, medical devices, contraceptives, insecticides and bactericides, and traditional medical equipment. This document provides detailed regulations on the quality management of products and goods in each group.
Đối tượng áp dụng
Production and business establishments of products and goods within the scope of management assigned to the Ministry of Health; organizations and individuals related to quality inspection and supervision activities of products and goods.
Các điểm cốt lõi
- Finished pharmaceutical products, vaccines, and therapeutic biological products must comply with national technical standards issued by the Minister of Health (Article 2.1).
- Raw materials for drugs and packaging that come into direct contact with drugs must also meet similar quality requirements (Article 2.1).
- Medical devices classified as types B, C, and D are managed under Decree No. 36/2016/NĐ-CP (Article 2.3).
- Contraceptive devices must comply with quality and safety usage regulations (Article 2.1).
- Insecticides and bactericides used in household and healthcare sectors are managed under Decree No. 91/2016/NĐ-CP (Article 2.4).
🌐 Tác động xã hội từ văn bản này
- Strengthening quality control of products and goods that may cause safety risks in the healthcare sector.
- Reducing health risks to consumers due to strict management of products and goods.
- Organizations and individuals involved must comply with new regulations, which may encounter difficulties during implementation.
❓ Câu hỏi thường gặp
Which list of products and goods is issued?
Circular No. 31/2017/TT-BYT issues the List of products and goods that may cause safety risks within the scope of management of the Ministry of Health.
What medical devices are specified in the list?
Medical devices classified as types B, C, and D according to Decree No. 36/2016/NĐ-CP.
How are insecticides and bactericides used in household areas managed?
According to the provisions of Decree No. 91/2016/NĐ-CP on the management of chemicals, insecticides, and bactericides.
What regulations must raw materials for drugs and packaging that come into direct contact with drugs comply with?
Must meet national technical standards issued by the Minister of Health (Article 2.1).
When does this circular take effect?
From September 15, 2017.
Toàn văn
| MINISTRY OF HEALTH |
SOCIALIST REPUBLIC OF VIET NAM Independence - Freedom - Happiness |
| Number: 31/2017/TT-BYT | Hanoi, July 25, 2017 |
CIRCULAR
ISSUING THE LIST OF PRODUCTS AND GOODS WITH POTENTIAL TO CAUSE SAFETY RISKS UNDER THE SCOPE OF MANAGEMENT ASSIGNED TO THE MINISTRY OF HEALTH
Pursuant to the Law on Product Quality and Commodities dated November 21, 2007;
Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing implementation of certain provisions of the Product Quality Law;
At the proposal of the Director of the Science, Technology and Training Department, Ministry of Health, the Minister of Health issues this Circular to issue the List of products and goods with potential to cause safety risks under the scope of management assigned to the Ministry of Health,
Article 1. Issuing the List
Attached hereto is the List of products and goods with potential to cause safety risks under the scope of management assigned to the Ministry of Health (hereinafter referred to as the List of products and goods group 2), including six groups of products and goods as follows:
1. Finished pharmaceutical products, vaccines, therapeutic biological products.
2. Raw materials for pharmaceutical products, packaging that directly contacts pharmaceutical products.
3. Medical devices classified as types B, C, and D as stipulated in Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on medical device management.
4. Contraceptive devices.
5. Insecticides and bactericides for household use (residences, schools, public buildings, offices, aircraft) and healthcare.
6. Traditional medical equipment.
Article 2. Quality Management of Products and Goods
1. The quality management of products and goods listed in the List of products and goods group 2 stipulated in this Circular shall be implemented through conformity declaration according to national technical regulations issued by the Minister of Health.
2. For products and goods listed in the List of products and goods group 2 stipulated in this Circular which have not yet been issued corresponding national technical regulations, quality management shall be implemented through compliance declaration according to standards published by the manufacturer.
3. For medical devices group 2 stipulated in this Circular, quality management of products shall be carried out in accordance with the provisions of Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on medical device management.
4. For insecticides and bactericides for household use (residences, schools, public buildings, offices, aircraft) and healthcare group 2 stipulated in this Circular, quality management shall be carried out in accordance with the provisions of Decree No. 91/2016/NĐ-CP dated July 1, 2016 of the Government on chemical substance, insecticide, and bactericide management for household use and healthcare.
Article 3. Effectiveness
This Circular takes effect from September 15, 2017.
Circular No. 44/2011/TT-BYT dated December 6, 2011 of the Minister of Health on issuing the List of products and goods with potential to cause safety risks under the scope of management assigned to the Ministry of Health shall cease to be effective from the date this Circular takes effect. During implementation, if there are any arising issues, difficulties, or obstacles, agencies, organizations, and individuals should promptly report them to the Ministry of Health for consideration and resolution within their authority.
During the implementation process, if there are arising issues, difficulties, or obstacles, agencies, organizations, and individuals shall promptly report to the Ministry of Health for consideration and resolution within their authority./.
|
Place of Receipt: |
THE MINISTER |
LIST
PRODUCTS AND GOODS WITH POTENTIAL TO CAUSE SAFETY RISKS UNDER THE SCOPE OF MANAGEMENT ASSIGNED TO THE MINISTRY OF HEALTH
(Attached to Circular No. 31/2017/TT-BYT dated July 25, 2017 of the Minister of Health)
|
No. |
Name of Product or Good |
|
1. |
Finished pharmaceutical products, vaccines, Therapeutic biological products |
|
2. |
Raw materials for pharmaceutical products, packaging that directly contactspharmaceutical productsspecialized agency under the People's Committee of the province/city. |
|
3. |
Medical devices classified as types B, C and D as stipulated in Decree No. 36/2016/NĐ-CP dated May 15, 2016 of the Government on medical device standards |
|
4. |
Contraceptive devices |
|
4.1. |
Contraceptive devices implanted/subcutaneously inserted. |
|
4.2. |
Contraceptive devices placed in the uterine cavity. |
|
4.3. |
Condoms and lubricants. |
|
4.4. |
Contraceptive devices applied on skin, placed, injected into the vagina. |
|
5. |
Insecticides and bactericides for household use (residences, schools, public buildings, offices, aircraft) and healthcare |
|
5.1. |
Incense sticks (incense) to repel and kill insects for household use and healthcare. |
|
5.2. |
Chemical-soaked pads to repel and kill insects (electric or non-electric) for household use and healthcare. |
|
5.3. |
Vaporizing insect repellents and killers for household use and healthcare. |
|
5.4. |
Insect repellent and insecticide sprays for household and medical use. |
|
5.5. |
Insect repellent and killer formulations in paste, powder, gel, cream, paint form for household use and healthcare. |
|
5.6. |
Insect repellent creams, gels, sprays, patches, bracelets for people. |
|
5.7. |
Insect repellent screens, curtains, hammocks, fabrics, papers soaked in chemicals for household use and healthcare. |
|
5.8. |
Insecticide sprays for household use and healthcare. |
|
5.9. |
Insect larvicide for household use and healthcare. |
|
5.10. |
Hand sanitizer without water for household use. |
|
5.11. |
Bathing solutions for bacterial control for patients and staff in healthcare. |
|
5.12. |
Surface and object disinfectants for household use excluding surfaces in direct contact with food and cleaning agents primarily for cleaning purposes. |
|
5.13. |
Water disinfectants for households. |
|
5.14. |
Skin disinfectants for healthcare (excluding antiseptics for wounds and mucous membranes; pre- and post-injection skin disinfectants; surgical site skin disinfectants). |
|
5.15. |
Surface and air sterilizers for healthcare. |
|
5.16. |
Insecticides and bactericides for aircraft. |
|
6. |
Traditional medical equipmentTraditional medical equipment |
|
6.1. |
Herbal decoction machines. |
|
6.2. |
Dry steam sauna machines. |
|
6.3. |
Wet steam sauna machines. |
|
6.4. |
Electro-acupuncture machines. |
|
6.5. |
Acupuncture needles. |
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