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A kind of medical equipment is what mean

Font Size: [Big][Mid][Small] 2017-2-15    Views: 143    

  Class I medical devices within the territory by the (food) drug supervision and administration institution under the district-constituted municipalities review, medical device registration certificate shall be issued after approval.

  In the second category of medical devices shall be determined by various provinces, autonomous regions and municipalities directly under the central government (food) drug supervision and administration department, medical device registration certificate shall be issued after approval.

  In the third class medical instrument by the state food and drug administration review and approval after the medical device registration certificate shall be issued.

  Overseas medical instrument by the state food and drug administration review and approval after the medical device registration certificate shall be issued.

  Taiwan, Hong Kong, Macao medical device registration, except as otherwise provided in the present measures, refer to overseas medical equipment to deal with.

  Medical device registration certificate valid for 4 years.

  Medical device registration certificate shall be uniformly printed by the state food and drug administration, the corresponding content by the examination and approval of registration (food) drug supervision and administration department to fill out.

  The registration number arrangement way is:

  X (x) 1 (food) drug safety machinery (x 2) words the first x 4 x x x x x 3 x 5 x x x x 6. Among them:

  Short for x 1 to register for examination and approval department is   located:

  Domestic third class medical equipment, medical apparatus and instruments overseas, Hong Kong, Macao and Taiwan regions of medical apparatus and instruments for the word "China";

  In the second category of medical apparatus and instruments for registration for examination and approval departments of provinces, autonomous regions and municipalities directly under the central government for short;

  Class I medical devices for registered within the territory of examination and approval departments of provinces, autonomous regions and municipalities directly under the central government or add in short for   administrative areas, the level of district-constituted municipalities for x 1 (without the corresponding administrative regions, the level of district-constituted municipalities is only short for provinces, autonomous regions and municipalities directly under the central government);

  X 2 for registration form (must), into, xu:

  "Quasi" word is suitable for the domestic medical apparatus and instruments;

  "Into" the word is suitable for the overseas medical apparatus and instruments;

  "Xu" is suitable for Taiwan, Hong Kong, Macao medical apparatus and instruments;

  X x x x 3 year of registration for approval;

  X 4 for product management category;

  X x 5 to varieties of products;

  X x x x 6 for the registered serial number.

  Medical device registration certificate attached to the medical device registration registration form "(see appendix 1) of these measures, used in conjunction with medical device registration certificate.

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