Tiếng Việt- 1 Law No. 05/2007/QH12 of November 21, 2007, on product and goods quality.
- 2 Decree No. 188/2007/ND-CP of December 27, 2007, defining the functions, tasks, powers and organizational structure of the Ministry of Health.
- 3 Decree No. 132/2008/ND-CP of December 31, 2008, detailing the implementation of a number of articles of the Law on Product and Goods Quality.
- 4 Decree No. 67/2009/ND-CP of August 03, 2009, amending a number of articles of The Government''s Decree No. 127/2007/ ND-CP of August 1, 2007, detailing a number of articles of the law on standards and technical regulations, and The Government''s Decree No. 132/2008/ND-CP of December 31, 2008, detailing a number of articles of the law on product and goods quality
| THE MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIET NAM |
| No. 44/2011/TT-BYT | Hanoi, December 6, 2011 |
CIRCULAR
PROMULGATING THE LIST OF PRODUCTS AND GOODS LIKELY TO BE UNSAFE SUBJECT TO THE MANAGEMENT ASSIGNED TO THE MINISTRY OF HEALTH
THE MINISTRY OF HEALTH
Pursuant to the November 21, 2007 Law on Product and Goods Quality; Pursuant to the Government’s Decree No. 188/2007/ND-CP of December 27, 2007, defining the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to the Government’s Decree No. 132/2008/ND-CP of December 31, 2008, detailing a number of articles of the Law on Product and Goods Quality;
Pursuant to the Government’s Decree No. 67/2009/ND-CP of August 3, 2009, amending a number of articles of Decree No. 127/2007/ND-CP of August 1, 2007, detailing a number of articles of the Law on Technical Standards and Regulations, and Decree No. 132/2008/ND-CP of the Government, detailing a number of articles of the Law on Product and Goods Quality;
At the proposal of the director of the Science and Training Department, the Ministry of Health,
STIPULATES:
Article 1. To promulgate the list
Promulgated together with this Circular is the list of products and goods likely to be unsafe subject to the management assigned to the Ministry of Health (below referred to as the list of products and goods of group 2), including 6 categories of products and goods:
1. Finished medicines, vaccines, biological products for treatment.
2. Medicine ingredients, pharmaceutical ingredients, adjuvants, capsules, packages in direct contact with medicines.
3. Medical equipment.
4. Chemicals, insecticides and germicides for household and medical use.
5. Toxic traditional herbs.
6. Traditional medical equipment.
Article 2. Management of quality of products and goods
The quality of products and goods on the list of products and goods of group 2 specified in this Circular shall be managed under relevant national technical regulations promulgated by the Minister of Health and other related regulations.
Article 3. Effects
This Circular takes effect on March 1, 2012.
Any problems arising in the course of implementation should be reported to the Ministry of Health for study and appropriate amendments and supplementations.-
|
| THE MINISTER OF HEALTH |
LIST
OF PRODUCTS AND GOODS LIKELY TO BE UNSAFE SUBJECT TO THE MANAGEMENT ASSIGNED TO THE MINISTRY OF HEALTH
(Promulgated together with Circular No. 44/2011/TT-BYT of December 6, 2011 of the Minister of Health)
| No. | Names of products and goods |
| 1 | Finished medicines, vaccines, biological products for treatment |
| 2 | Medicine ingredients, pharmaceutical ingredients, adjuvants, capsules, packages in direct contact with medicines |
| 3 | Medical equipment |
| 3.1 | X-ray diagnostic and treatment equipment |
| 3.2 | Endoscopy system |
| 3.3 | Infusion pump |
| 3.4 | Electric syringe pump |
| 3.5 | Surgical knife (high-frequency current, laser, ultrasound) |
| 3.6 | Newborn babies’ incubator |
| 3.7 | Newborn babies’ heater |
| 3.8 | Anesthesia, integrated anesthesia respiratory carestation |
| 3.9 | Respiratory support machines |
| 3.10 | Defibrillators, pacemakers |
| 3.11 | High-pressure oxygen chambers |
| 3.12 | Contact lenses (myopic, hyperopia, astigmatism) |
| 3.13 | Equipment and materials for long-term implanting (more than 30 days) in the body |
| 3.14 | Equipment and materials for body intervention, for vascular cardio, neurological, intracranial and cerebral diseases |
| 3.15 | Central medical gas systems |
| 4 | Chemicals, insecticides and germicides for household and medical use |
| 4.1 | Mosquito incenses |
| 4.2 | Mosquito repellent tablets |
| 4.3 | Insecticidal sprays |
| 4.4 | Insect poisons |
| 4.5 | Mosquito repellent creams |
| 4.6 | Electrically-activated mosquito repellent solutions |
| 4.7 | Mosquito nets with mosquito repellents and killers |
| 4.8 | Insecticidal chemicals and preparations |
| 4.9 | Chemicals and preparations for killing mosquito larvae |
| 4.10 | Chemicals and preparations for antiseptic hand washing |
| 4.11 | Chemicals and preparations for sterilizing medical instruments |
| 4.12 | Chemicals and preparations for cleansing medical instruments |
| 4.13 | Chemicals and preparations for sterilizing daily-life water and swimming pool water |
| 4.14 | Chemicals and preparations for skin antiseptic |
| 4.15 | Chemicals and preparations for surface antiseptic |
| 4.16 | Preparations for fruits and foods for use as household germicides |
| 5 | Toxic traditional herbs |
| 5.1 | Moc thong - Caulis aristolochiae Manshuriensis, C. armaandii, C.monttana |
| 5.2 | Phu tu - Radix Aconitii lateralis |
| 5.3 | O dau - Radix Acontitii fortunei, armichaeli |
| 5.4 | Te tan - Herba Asari |
| 5.5 | Ma tien - Semen Strychni |
| 5.6 | Quang phong ky - Radix Aristolochia Fangchi |
| 5.7 | Cam toai - Radix Euphorbiae Kansui |
| 5.8 | Ba dau - Fructus Crotonis |
| 5.9 | Than sa - Cinnabaris |
| 5.10 | Hung hoang - Realger |
| 5.11 | Bang sa - Natri tetraborat (Nabh4) |
| 5.12 | Thuong luc - Radix Phytolaccae |
| 5.13 | Dai kich - Radix Euphorbiae |
| 5.14 | Ma dau linh - Aristolochia contorta; A debilis |
| 5.15 | Thien nam tinh - Arisaema erubescens; A. heterophylium |
| 5.16 | Ca doc duoc (duong kim hoa) - Datura metel |
| 5.17 | Chu sa - Mercury Sulfur (HgS) |
| 5.18 | Xa huong - Moschus |
| 5.19 | Voi voi - Heliotropium indicum |
| 6 | Traditional medical equipment |
| 6.1 | 16-tube medicament cookers |
| 6.2 | Packing machines |
| 6.3 | Medicament cookers |
| 6.4 | Dry-heat sauna machines |
| 6.5 | Steam sauna machines |
| 6.6 | Electric acupuncture machines |
| 6.7 | Acupuncture needles |
- 1 Circular No. 42/2016/TT-BTTTT dated December 26, 2016, on the list of potentially unsafe goods and products under the management of the Ministry of information and communications
- 2 Circular No. 39/2016/TT-BGTVT dated December 06, 2016 on the list of potentially unsafe commodities under the management of the Ministry of Transport
- 3 Decree No. 132/2008/ND-CP of December 31, 2008, detailing the implementation of a number of articles of the Law on Product and Goods Quality.
- 4 Decree No. 188/2007/ND-CP of December 27, 2007, defining the functions, tasks, powers and organizational structure of the Ministry of Health.
- 5 Law No. 05/2007/QH12 of November 21, 2007, on product and goods quality.
- 1 Circular No. 42/2016/TT-BTTTT dated December 26, 2016, on the list of potentially unsafe goods and products under the management of the Ministry of information and communications
- 2 Circular No. 39/2016/TT-BGTVT dated December 06, 2016 on the list of potentially unsafe commodities under the management of the Ministry of Transport