Good Manufacturing Practice for Medical Device (Exposure Draft) G/TBT/N/CHN/2073

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 [ ], 2.10.1 [ ], 5.6.2 [X], 5.7.1 [ ],3.2 [ ], 7.2 [ ], other:

4.

Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Medical device (HS code(s): 90); (ICS code(s): 11)

5.

Title, number of pages and language(s) of the notified document: Good Manufacturing Practice for Medical Device (Exposure Draft); (35 page(s), in Chinese)

6.

Description of content: The document standardizes the quality management of medical device production, and ensures the safety and effectiveness 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

E-mail: tbt@customs.gov.cn