Outside the medical device market has been permitted for the fir

发布时间：[2007-11-02]     点击次数：2192

Name of the Project: The first registration of imported medical devices
Second, licensing content: has been listed on offshore medical device license for the first time outside the medical device registration

Third, set up and the legal basis for licensing:
"Medical Devices Regulations," Article, "Medical Device Registration"

4, Charges: 3,000 RMB / month.
Charges based on: the Ministry of Finance, State Development Planning Commission document "Review of Medical Devices on the change of name of the reply of fees" (Cai Zong Zi [2000] 15), the State Price Bureau, Ministry of Finance document "on the release of central management of the medical system administrative fees and standards of notice "([1992] price fee 534 words).

5, quantitative restrictions: no limit on the number of the licensed items.

6, the applicant submitted materials directory:
Data No. 1, outside the medical device registration application form;
Data No. 2, medical equipment manufacturers, Certification;
Information on number 3, or report a copy of business license granted to the agency and production company registered power of attorney;
Data No. 4, outside the government department in charge of medical devices approved or endorsed the product as a medical device into the country (region) documents the market;
Data No. 5, the applicable product standard (two);
Data No. 6, instructions for use;
Data No. 7, the medical device testing institutions and product registration test report (for the second, three types of medical devices);
Data No. 8, the medical device clinical trials;
Data No. 9, issued by the manufacturers guarantee product quality;
Data No. 10, manufacturers in China, the designated agent of the power of attorney, the agent of the undertaking and the business license or registration certificate;
Information No. 11, the designated service agency in China, power of attorney, by the commission of commitment and qualification documents;
Data No. 12, submitted a statement the truthfulness of self-assurance.

7, information on the application requirements:
(A) general requirements for disclosure of information:
1, reporting information page for the project claims data directory, the directory data items reported by "Medical Device Registration" Annex 6 of the order. Information page for each seal, indicate the product name on the cover page, the applicant name, the upper right corner indicate the name of the data. Should be used between the data a clear distinction between signs, and marked the two, one copy of claims data, reporting data should use A4 size paper to print, the contents of a complete, clear, shall not be altered, the Government and other organizations issued by the original size of the file provide.
3 copies of claims data should be clear.
4, the (public approval documents, standards, test reports, manuals) to declare the information in the product name should fill out the application form in the substantive content of the product name corresponds to. If trade names, trade names should be marked. Declarations shall be in Chinese, translation of foreign materials according to claims data, should provide the original. Chinese signature implementation [2004] 499 Man.
5, reporting the information received, the enterprise may not add their own applications, but are "Medical Device Registration" 38th Article circumstances, you can add applications.
(B) specific requirements for disclosure of information:
1, outside the Medical Device Registration Application Form
(1) medical device registration application form can be downloaded from the www.sda.gov.cn;
(2) Medical Device Registration Application Form is one of the important information on application for registration, form complete description of the requirements should be consistent.
2, Medical Device Manufacturing Enterprise Certification
(1) production of medical devices can be legally eligible for documentation;
(2) copies of a certification authority shall be the original signature or by the local notary notarized;
(3) in the period (if any).
3, or report a copy of business license and production company registered power of attorney granted to the agent
(1) Applicant's business license
① can copy, but must be stamped with official seal certificates owned enterprises;
② in the period.
(2) proxy signature registered power of attorney by the manufacturer.
4, outside the government department in charge of medical devices approved or endorsed the product as a medical device into the country (region) documents the market (or as medical devices in China, has been in the overseas market as proof of legal drugs.)
(1) The original copy shall be subject to a certification authority or by the local notary signature notarized;
(2) within the validity period (if any).
5, product standards
(1) standard text;
(2) the preparation of instructions (for registered product standards);
(3) The declaration shall be included in the product standard product range;
(4) adoption of national standards, industry standards as a product of the applicable standards of:
① manufacturer shall provide the requested products meet national standards, industry standards, a statement by the manufacturer signature;
② manufacturers take responsibility for the quality of after-market statement, signature by the manufacturer;
③ manufacturer of the product models, specifications classification description by the manufacturer signature.
(5) registered product standard should be the manufacturer or its representative office in China, signature or production company commissioned the drafting of the standard unit of signature, the production company commissioned the drafting of the standard power of attorney should be marked "Product Quality by the production company responsible for" by the manufacturer signature.
6, instructions for use
(1) should provide instructions; omit the description of the documentation issued by the manufacturer by manufacturer signature;
(2) Category II, Class III medical devices by the manufacturer or its description should be representative office in China, signature, and the first instructions for use can not seal.
7, test report (for category II, Class III medical devices)
(1) the seized product specifications and models should be within the scope of this application for registration;
(2) test type should be registered test or full performance of state supervision and random testing;
(3) original;
(4) period (implementation of the "Medical Device Registration" Annex 6, 7).
Note: The implementation of the "Medical Device Registration" Article, Article XII, Article XIII, it shall provide the appropriate documentation by the manufacturer or its representative office in China, office or signature.
(5) implementation of the "Medical Device Registration" of Article XV, manufacturers should be proposed to suspend the testing of applications and commitment to signature by the manufacturer.
8, the medical device clinical trials
(1) in accordance with the "Medical Device Registration" in the provisions of Annex 12 to submit the report within the clinical
① should two or more enterprises (including 2) "National Drug clinical research base" for clinical trials;
② The clinical trial data in clinical trials should include contracts, clinical trial, clinical trial reports:
a, clinical trials, clinical trials, the contract should bear the medical institutions and practitioners signed and sealed;
b, clinical trial program of the Ethics Committee should undertake clinical trials of medical institutions and practitioners seal;
c, clinical trial reports should be responsible for clinical trials and clinical trial staff who signed stamped and certified by the testing authorities.
(2) in accordance with the "Medical Device Registration" in Annex 12 requiring the submission of foreign clinical reports to be submitted to foreign government approval of the competent medical device product or (similar product) when the registration of clinical trials listed by the production business or office or representative office in China signature.
9, the production company should guarantee the product quality
Signature by the manufacturer.
10 manufacturers in China, the designated agent of the power of attorney, the agent of the undertaking and the business license or registration certificate
(1) power of attorney agent signing by the manufacturer;
(2) the agent undertaking signature by an agent;
(3) business license or registration certificate of the signature by the certificate owned enterprises.
11, the designated service agency in China, power of attorney, the undertaking by the commission and qualification documents
(1) service of the power of attorney signature by the manufacturer;
(2) the undertaking by the commission by the commission by the signature;
(3) certificate of qualification documents owned enterprises by the signature.
12, the authenticity of the materials submitted by the self-assurance statement
(1) by the manufacturer or its representative office in China issued by the manufacturer or its representative office in China, signature;
(2) The statement should contain a list of materials submitted;
(3) includes liability commitments.

8, bid process diagram:




9, permit procedures:
(A) accepted:
Applicants accepted to the Administrative Service Center to apply, in accordance with the "Guide" directory listed in Article VI to submit application materials, receiving center staff in accordance with the "territory of the third category, foreign medical device registration standards for disclosure of information received" (State armed Drug Administration [2005 ] 111) requires the form of review of application materials. For matters not subject to administrative licensing law, it shall immediately inform the applicant of the rejection; matter applied for is not within the scope of executive authority, shall immediately make a decision of rejection, and inform the applicant to the relevant administrative organ; application materials that can be corrected on the spot the error, it shall allow the applicant on the spot corrections; application materials are incomplete or do not meet the statutory form, on the spot or within five days, inform the applicant to make corrections of all, those who do not tell, from the collection to the date of the application materials shall be accepted; for matters within the administrative organs of the terms of reference, application materials are complete and comply with the statutory form, or the applicant in accordance with the requirements of the executive to submit all application materials to make corrections, it shall application for administrative license.
(B) review:
Administrative accept service center received the case, the application materials will be sent for Medical Devices Evaluation Centre, the technical review, technical review, including product testing and expert review, the technical review can not exceed 60 days. However, peer-reviewed, make correction to the applicant, the applicant is not included in licensed rectification period of time.
(C) permit decisions:
Receive the Medical Devices Evaluation Center of the technical review of information, the State Food and Drug Administration to be registered within 30 days of the decision or not registered, not registered, it shall give reasons in writing.
(D) be served:
Since the administrative licensing decision within 10 days from the date, SFDA administration accepted the decision of administrative licensing service center will be served on the applicant.

10, promised time frame: the date of acceptance, to make administrative licensing decision within 90 days.

11, implementation of the authority:
Implementation of the authorities: the State Food and Drug Administration
Accepted Location: State Food and Drug Administration accepted the executive service center

12, for a change:
Medical devices listed in the contents of a certificate of registration changes, changes in the license, shall, within 30 days from the date of the application change processed or re-register.

13, license validity period and renewal:
Medical device product registration certificate valid for four years. Unit holder shall before the expiry of registration certificate within 6 months to apply for new registration.

14, license or annual inspection examined: None

15, received inquiries and complaints by:
Advisory: State Food and Drug Administration Medical Device Companies Registry
Complaint: State Food and Drug Administration Resident Supervision Bureau, Policy and Regulation Department, law enforcement supervision
Note: The duration of the notes to working days, excluding legal holidays

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