NOTIFICATION
The following notification is being circulated in accordance with Article 10.6
| 1. |
Notifying Member: China If applicable, name of local government involved (Article 3.2 and 7.2): |
| 2. |
Agency responsible: National Medical Products Administration Name and address (including telephone and fax numbers, email and website 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): Medical Devices; (HS: 90); (ICS: 11) |
| 5. |
Title, number of pages and language(s) of the notified document: Provisions for Medical Devices Registration (31 page(s), in Chinese) |
| 6. |
Description of content: This document prescribes the relevant requirements for approval and filing of medical devices. |
| 7. |
Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety |
| 8. |
Relevant documents: - |
| 9. |
Proposed date of adoption: To be determined Proposed date of entry into force: To be determined |
| 10. |
Final date for comments: 60 days from notification |
| 11. |
Texts available from: National enquiry point[X] or address, telephone and fax numbers and email and website addresses, if available, of other body: WTO/TBT National Notification and Enquiry Center of the People's Republic of China
Tel: +86 10 57954633 / 57954627
Email: tbt@customs.gov.cn https://members.wto.org/crnattachments/2021/TBT/CHN/21_3178_00_x.pdf |
