WORLD TRADE
ORGANIZATIONG/TBT/N/JPN/3
16 January 2001
(01-0213)
Committee on Technical Barriers to Trade Original:  English
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   JAPAN
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Ministry of Health, Labour and Welfare
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of  agency or authority designated to handle comments
regarding the notification shall be  indicated if different from above:           
3. Notified under Article 2.9.2 [ X], 2.10.1 [    ], 5.6.2 [    ], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Lung ventilators for
medical use (HS:  90.19)
5. Title, number of pages and language(s) of the notified document:   Alarm and other
requirements for lung ventilators for medical use under Article 42 Paragraph 2 of the
Pharmaceutical Affairs Law (1 page, available in English)
6. Description of content:   Alarm and other requirements for lung ventilators for medical use
will be established under Article 42, Paragraph 2 of the Pharmaceutical Affairs Law.  The
new standards will be applied to ventilators used for patients who cannot ventilatespontaneously.  No ventilator which is not in conformity with the new standards shall be
sold, manufactured, imported etc. under Article 65 of the Pharmaceutical Affairs Law.
7. Objective and rationale, including the na ture of urgent problems where applicable:
The objective is to prevent medical accidents related to lung ventilators for medical use
caused mainly by the failure of their alarms possibly after the airway suction treatment to
ventilated patients.
8. Relevant documents: Pharmaceutical Affairs Law
The new standards will appear in "KAMPO" (Official Government
Gazette) when promulgated
9. Proposed date of adoption:  April 2001
Proposed date of entry into force:  April 2001
10. Final date for comments:   20 March 2001
11. Texts available from:  National enquiry point [ X] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body:  Evaluation and
Licensing Division, Pharmaceutical and Medical Safety Bureau, Ministry of Health, Labourand Welfare
Tel: +81-3-3595-2431
Fax:: +81-3-3597-9535