New CFDA-Catalogue for Medical Devices

CFDA published a new catalog for the classification of medical devices.

The CFDA (China Food and Drug Administration) published a new classification catalog on 31.08.2017 (No. 2017-104). The new catalog, with more than 2,000 entries of product classifications, is much more extensive than the previous catalog, which featured only around 200 product examples. It is clear that many product classifications will change as of 1 August 2018, when the new catalog and its implementation regulations are put into effect. Excluded from this are in-vitro diagnostics reagents, as their currently used classification guidelines will remain valid.

  Old Classification Catalogue New Classification Catalogue
Entries of product examples

~200

>2,000

Categories

43

22

Class I subcategories

104

380

Class II subcategories

123

777

Class III subcategories

7

404

CFDA revised two regulations regarding food for special medical purposes

On 6 September 2017, CFDA published announcement (No. 2017-108), in which the „Application Documents and Requirements for the Registration of Food for Special Medical Purpose (Trial)“ and the „Stability Research Requirements on Food for Special Medical Purpose (Trial)“ are revised.

Certification requirement for all food imports to China is suspended until 30 September 2019

As mentioned in our Foreign Trade News from July 2017, food products should only be imported in China with an official certificate of clearance as of 01.10.2017. The WTO (Word Trade Organization) is now circulating a communication (dated 22 September 2017) on behalf of AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine) announcing that, on the basis of the comments received, a transitional period of 2 years will be granted.

For further information on the above topics, please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00
info@cisema.de
www.cisema.com