" standard of medical devices runs way " (try out) (bureau make the 31st

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" standard of medical devices runs way " (try out) (bureau make the 31st)

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The 3rd chapter.
Make and release of national level and occupation standard

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The 10th.
Method of the demand that the standard drafts an unit to answer a standard, experiment, test gauge criterion, begin scientific test and verify, have a technology

It is analysis, good to do collect of test and verify, by the regulation the draft standard that draft stalks of grain, write description for drawing up standard and concerned accessory.

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Eleventh.The specialized standard of each medical devices that level of state of medical devices and occupation standard establish by the country turns technical committee

Or the organization of committee of technology of standardization of medical devices that supervisory management department of medicines and chemical reagents of the State Council creates is made and examine and verify.

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Dozenth.
Authorized the standard after is revised by the requirement by the unit that draft, via check of corresponding secretariat of standardization technology committee

Hind, the newspaper sends medicines and chemical reagents of the State Council to supervise management department. Occupation standard is examined and approve by supervisory management department of medicines and chemical reagents of the State Council, number, release.

...........The 4th chapter. Register product level make and examine and verify

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Thirteenth.
Register product standard to should carry out national level, occupation standard and the requirement of concerned law, code, press state

Supervisory management department of courtyard medicines and chemical reagents announces " medical devices registers product standard to write a standard " ask to draft.

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The 14th.
Manufacturer should supervise management department to refer to medicines and chemical reagents when declaring a product to register register product standard text and level

The work out explains.

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Register product description for drawing up standard to should include following content:

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(one) whether is the material that contacts with human body already clinical on had applied, whether does its security, dependability get a proof;

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(2) the relative standard that cite or consults and data;

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(3) the basis with administrative firm category;

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(4) the basis with product introduction and main technique firm clause;

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(5) the product measures a report oneself;

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(6) the content that other needs to explain.

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The 15th.
The enrollment that imports medical devices product standard supervises management department check by medicines and chemical reagents of the State Council.

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The enrollment that churchyard produces the 3rd kind of medical devices product standard monitors management department first trial by medicines and chemical reagents of province, municipality, municipality directly under the Central Government, newspaper

Medicines and chemical reagents of the State Council supervises management department check.

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The enrollment that churchyard produces the 2nd kind of medical devices product standard supervises management department check by medicines and chemical reagents of province, municipality, municipality directly under the Central Government.

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The enrollment that churchyard produces the first kind of medical devices product standard supervises management department check by the city class drug that establishs a division.

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The 16th.
The main content that first trial and check register product level is:

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(one) whether to accord with active and significant state level, occupation standard to reach concerned law, code;

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(2) whether does product denomination accord with concerned regulation requirement;

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(3) those who expect use is affirmatory accurate;

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(4) the project is decided really and examine regular rationality;

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(5) method of test and verify and conclusion of test and verify are correct.

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The seventeenth.
Register a product to the standard is arranged according to check opinion by manufacturer or be revised, supervise management department by the medicines and chemical reagents of check

Number, put on record.

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Register product level number by register abbreviation of seat of orgnaization of check of product standard code name, standard (the country is fastened) , register product standard to arrange

Serial number and time date are comprised.

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Among them the medical devices that churchyard of correspondence of abbreviation of seat of standard check orgnaization produces, be or two Chinese characters, it is to point to country, province,

Abbreviation of municipality, municipality directly under the Central Government, or province, municipality ＋ sets area city abbreviation. The country fastens abbreviation to express to be 3 English letter, of corresponding entrance

Medical devices.

Give typical examples:

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YZB.
/ X (XXX). XXXX - XXXX

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╲ of ▔ ▔ ▔
▔ of ▔ of ▔ of ▔ ▔ ▔
╲ of ▔ of ▔ ▔ ▔
▔ of ▔ ▔ ▔ releases the title of an emperor‘s reign

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│..
│......│

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│......│........─ of ─ of ─ of └ ─ ─
Register product standard to arrange serial number

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│..
│

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│......─ of ─ of ─ of ─ of ─ of ─ of ─ of ─ of ─ of └ ─ ─
Abbreviation of seat of standard check orgnaization (the country is fastened)

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│

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─ of ─ of ─ of ─ of ─ of ─ of ─ of ─ of ─ of ─ of ─ of ─ of ─ of ─ of ─ of ─ of └ ─ ─.Register product standard code name

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The 18th.
After every state level, occupation standard is released via editing, before be carried out formally, manufacturer should the basis edits, hair

The national level of cloth, occupation standard is revised register product level, fill in " medical devices registers product standard to revise sheet " , sign up for original review a case in which a death sentence has been passed by a lower court

Sectional review a case in which a death sentence has been passed by a lower court.

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The 19th.
The content that manufacturer should provide to registering product standard place is responsible