New NMPA Classification Catalogue for Medical Devices

NMPA published a new classification catalogue for medical devices.The NMPA (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 CatalogueNew Classification CatalogueEntries of product examples

~200

>2,000

Categories

43

22

Class I subcategories

104

380

Class II subcategories

123

777

Class III subcategories

7

404

NMPA revised two regulations regarding food for special medical purposes On 6 September 2017, NMPA 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 2019As 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.Contact Cisema for further information on the above topics.