Self-cancellation of the first type of medical equipment filing procedures

Medical network February 9 hearing to clear the first type of medical equipment to cancel their own record of the information requirements and working procedures to guide the record holder to carry out related work, the General Administration of Medical Device Registration Management Division has formulated "to cancel the import of the first category of medical equipment Filing procedures "(see annex).

Special announcement.

Annex: Self-cancellation of the first type of medical equipment registration procedures

State Administration of Food and Drug Administration reception service hall

February 8, 2018

annex

First, the project each said: to cancel the import of the first category medical instruments For the record.

Second, the scope of acceptance: filing a proposed cancellation of the first category of medical equipment for the record.

Third, charging basis: no charge.

Fourth, handling conditions: made by the filing of applications.

Fifth, application information requirements:

(A) the signing of the signature of the cancellation of the filing of the statement, the statement should include the record number of the record to cancel the filing, cancel the record of the reasons and circumstances.

(B) the record holder enterprise The original or a copy of the notarized copy of the qualification certificate.

(C) the original medical device record voucher.

(4) Self-assurance statements concerning the authenticity of the information submitted by the record holder, including the list of materials submitted and the commitment of the record holder to bear legal liabilities.

(E) The specific handler should be submitted to the record holder or its proxy Man power of attorney and a copy of his ID card.

Six, procedures:

(A) food drug The Administrative Service of Accepting Administrative Substances of the General Administration of Administration and the Center of Reporting and Complaint Reporting formally examine the application materials for the cancellation of the filing and accept the application materials that meet the application requirements.

(B) of the Food and Drug Administration Administrative Services Receiving complaints and complaints reporting center receiving department within 10 working days since accepting the relevant information to the Food and Drug Administration Information Center, the Food and Drug Administration Information Center will Food and Drug Administration website The published record information is marked as '* * month * day to cancel the record' (which cancels the record time for the record filing time).