Difference Between Health Food Registration (Big Blue Hat) and Filing (Small Hat)

Items

Registration

Filing

Applicable scope

I. Domestic health food of which the food raw materials are out of the scop e of Health Food Raw Material Directory

II. Imported health food (excluded nutrition supplement )

I.Domestic health food of which the food raw materials meet the requirements in Health Food Raw Material Directory.

II. Imported nutrition supplement of which the vitamins and (or) minerals meet the requirements in the Health Food Raw Material Directory.

Applicant's qualification

I.The registration applicant of domestic health food could be the legal person or other organization registered in China.

II. The registration applicant of Imported health food should be the manufacturer.

The filing applicant shall be the manufacturer.

Authority

CFDA

CFDA for imported nutrition supplement. And FDA for domestichealth food.

Format of the registration No. and filing No.

I. Format of the domestic registration No. is “ 国食健注 G+4 位年代号 +4 位顺序号 ”

II. Format of the imported registration No. is “ 国食健注 J+4 位年代号 +4 位顺序号 ”

I. Format of the domestic filing No. is “ 食健备 G+4 位年代号 +2 位省级行政区域代码 +6 位顺序编号 ”

II. Format of the imported filing No. is “ 食健备 J+4 位年代号 +00+6 位顺序编号 ”

Validity period of the certificate

5 years. And the applicant of health food registration should apply for certificate extension at 6 months before the expiry date.

Permanent

Application procedure

CFDA technical evaluation that is mandatory for registration, on-site inspection and re-test which may be required for registration are exempted for filing.

Dossier

Compared with the requirements of registration, R&D report, assessment materials regarding product safety and function or samples are not necessary to be provided when filing.

Cost

Compared with registration cost, the re-test cost (about 20,000 RMB) could be saved for filing.

Duration

Compared with registration duration, the technical evaluation (in 60 workdays), CFDA approval (in 25 workdays) on-site inspection if necessary for registration (in 30 workdays), re-test if necessary for registration (in 60 workdays) could be saved for filing.

Applicant's qualification

The applicants of imported health food registration and filing both shall be the manufacturers.

Authority

The authority of imported health food registration and filing both are CFDA.

Dossier

Except the exempted dossier for filling, other requirements of the submitted dossier required are the same when registration and filing.

Tests

Active ingredients test, hygiene test and stability test are necessary for both registration and filing.

Official administrative cost

No need for both registration and filing.

Agent for applying

Oversea manufacturer shall make the Chinese office or appoint a Chinese agent to deal with registration or filing.