The Amendment to the Procedures for Special Examination and Approval of Innovative Medical Devices (Draft) G/TBT/N/CHN/1271

1.

Notifying Member: China

If applicable, name of local government involved (Article 3.2 and 7.2):

2.

Agency responsible: China National Drug 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 [ ], 2.10.1 [ ], 5.6.2 [X], 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): Drugs; Medicaments (ICS 11.120.10).

5.

Title, number of pages and language(s) of the notified document: The Amendment to the Procedures for Special Examination and Approval of Innovative Medical Devices (Draft) (14 page(s), in Chinese)  

6.

Description of content: This Amendment is the revision of the Procedures for Special Examination and Approval of Innovative Medical Devices. It modified the application documents, procedures, notification method, etc..

7.

Objective and rationale, including the nature of urgent problems where applicable: Prevention of deceptive practices and consumer protection

8.

Relevant documents: None

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 84603889/84603950
Fax: +86 10 84603811
E-mail: tbt@aqsiq.gov.cn

https://members.wto.org/crnattachments/2018/TBT/CHN/18_2515_00_x.pdf