THE MINISTRY OF HEALTH
Circular No. 31/2017/TT-BYT dated July 25, 2017 of the Ministry of Health on the List of potentially unsafe goods under the management of the Ministry of Health
Pursuant to the Law on Goods Quality dated November 21, 2007;
Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 on functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to the Government’s Decree No. 132/2008/ND-CP dated December 31, 2008 specifying the implementation of certain articles of the Law on Goods Quality;
At the request of the Director of the Administration of Science Technology and Training affiliated to the Ministry of Health, the Minister of Health promulgates a Circular on the list of potentially unsafe goods under the management of the Ministry of Health,
Article 1. Promulgation of the list
This Circular shall enclose the list of potentially unsafe goods under the management of the Ministry of Health (hereinafter referred to as “list of group 2 goods ") including 6 categories of goods as follows:
1. Commercial medicines, vaccines, biological products for disease treatment.
2. Medicine ingredients, primary packages of medicines.
3. Type B, C and D medical equipment specified in the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016 on the management of medical equipment.
4. Contraceptives.
5. Insecticides andgermicides for domestic use (housing, schools, public works, office buildings or airplanes) and medical use.
6. Traditional medical equipment.
Article 2. Management of goods quality
1. The management of quality of group 2 goods specified herein shall be published in line with the national technical regulation promulgated by the Ministry of Health.
2. The management of goods on the list of group 2 specified herein that have not applied the corresponding national technical regulation shall be published according to regulations of law on standards of producers.
3. Quality of group 2 medical equipment stipulated herein shall be managed in accordance with the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016 on management of medical equipment.
4. Quality of group 2 insecticides and germicides for domestic use (housing, schools, public works, office buildings or airplanes) and medical use prescribed herein shall be managed according to provisions of the Government’s Decree No. 91/2016/ND-CP dated July 01, 2016 on management of chemicals, insecticides and germicides for domestic and medical uses.
Article 3. Effect
This Circular takes effect on September 15, 2017.
The Circular No. 44/2011/TT-BYT dated December 06, 2011 by the Ministry of Health on the list of potentially unsafe goods under the management of the Ministry of Health shall be replaced by this Circular from the effective date.
Any problems arising in the course of implementation shall be promptly reported to the Ministry of Health.
The Minister
Nguyen Thi Kim Tien
LIST OFPOTENTIALLY UNSAFE GOODS UNDER THE MANAGEMENT OF THE MINISTRY OF HEALTH
(Attached to the Circular No.31/2017/TT-BYT dated July 25, 2017 by the Ministry of Health)
No. | Names of goods |
1. | Commercial medicines, vaccines, biological products for disease treatment |
2. | Medicine ingredients, primary packages of medicines |
3. | Type B, C and D medical equipment specified in the Government’s Decree No. 36/2016/ND-CP dated May 15, 2016 on the management of medical equipment |
4. | Contraceptives |
4.1. | Implants. |
4.2. | Intrauterine devices (IUDs). |
4.3. | Condoms and lubricants. |
4.4. | Transdermal contraceptive patches, vagina rings and injections. |
5. | Insecticides and germicides for domestic use (housing, schools, public works, office buildings or airplanes) and medical use |
5.1. | Insect repellent incenses. |
5.2. | Electric or non-electric insect repellent and killer mats. |
5.3. | Insect repellent and killer solutions. |
5.4. | Insecticidal sprays. |
5.5. | Insect poisons in the form of powder, gel or spray. |
5.6. | Insect repellent lotions, gel, sprays, mats or bracelets for human. |
5.7. | Insect repellent or killer nets, curtains, hammocks, fabric or paper impregnated with chemicals. |
5.8. | Insecticidal chemicals and preparations. |
5.9. | Preparations used for killing mosquito larvae. |
5.10. | Gel hand sanitizer for domestic use. |
5.11. | Antiseptic lotions for patients and medical officers. |
5.12. | Disinfectants applied to tools, surfaces or household utensils not including surfaces in direct contact with food and preparations mainly used for cleaning purposes. |
5.13. | Anti-bacteria chemicals used for domestic water. |
5.14. | Skin antiseptics for medical use (excluding human wound and mucous membrane antiseptics; skin antiseptics used for patients before and after they are given an injection; skin antiseptics after undergoing a surgery). |
5.15. | Germicides used for surfaces and air for medical purposes. |
5.16. | Insecticides and germicides used on airplanes. |
6. | Traditional medical equipment |
6.1. | Medicament cookers. |
6.2. | Dry-heat sauna machines. |
6.3. | Steam sauna machine. |
6.4. | Electric acupuncture machines. |
6.5. | Acupuncture needles. |
Vietnamese
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