航海王733集:The evolution of the registration of medical devices

A, 1995 (1989-1994) before in carrying out the product registration of medical devices, before recognition method is identification management, divided into national and provincial two-level identification. As countries YiXie terengganu word, X (province abbreviation) YiXie terengganu word, its effect and now product registration certificate is equivalent. If YiXie terengganu word anhui 98 ago for old medicine administrative bureau approval is registered, three characteristics: 1, 2, classification and implement prison now reversed, such as class 1 apparatus is now three classes, 3 class is now a category 1. 3, (1995-1996) began to implement registration management, registration Numbers: clamps its X1 pill prison X2 word XX3 first X4XX5XXX6 number 6 digits. Clamps its X1 said an accepting institution (national, provincial or city divided into districts shall) X2 said registered form (must), respectively, into, xu: it is suitable for domestic medical equipment into: foreign products hui: Hong Kong, Macao and Taiwan products XX3 indicate approval register after two years (said) X4 management category note: product management category for product 3, 2, 1 (3 said class 1, 1 if the class 3) XX5 said product variety coding, But if X2 (try it) for XX5 is terminated year XXX6 said registered for 3 digit serial number, if X2 as "into" "xu", then X4XX5XXX6 unification as a serial number (4 digits) such as approval: anhui province pill prison (must) words first 326002 date; 95. Lu pill prison (must) words (96) is the first 326003 number enterprise prison (quasi-optimal) words 126008 number GuoQi 95 first prison (into) words, for example: 1027 96 first approved by the state administration for medicine: enterprise implement prison (quasi-optimal) words (97) first 125006 number two, 98-2004 renamed called drug administration 1, try name appears characteristic is overdue time 2, instead of tube, 123 classification to spurt current classification 3, promoted to seven since 1997 (1997-1999.3) and the state administration for medicine makes 16 clamps its X1 pill XX3 first X4XX5XXX6 prison X2 word, but instead X4 1, 2, 3 class (-1) class 1... 1999.4-2000.4 (is rare) pill prison instead of medicine tube clamps its X1 medicine tube spurt spurt XX3 X4XX5XXX6 such as the first word X2 spurt (try) tube enterprise 2000.4 after the first word 99 301009 XX3 instead of four digits year, XXX6 instead of four digits serial number (national regulators to the 16th) tube clamps its X1 medicine XXXX3 first X4XX5XXXX6 spurt X2 word now X2 (into, xu), no unified for X4XX5XXXX6) serial number (for example: lu medicine tube spurt (try) words the first 200500195 (2005) audition expired robust medicine tube spurt (quasi-optimal) 2003 2260015 number enterprise first word gave (make) words tube 2400027 number 2001 first gave (into) tube enterprise 2002 the first word 2400815 date 3, 2004 by the food and drug administration approed 1, 2, instead of food developto spurt in August 2004 after 9 no longer approval try typefaces product device registration certificate by the state food and drug administration shall be uniformly printed by the examination and approval, the corresponding contents of registered (food and drug supervision and administration departments to fill out. Number of layout risk for: * (x) 1 (food) developto the butterfly (x 2) words x subjcet 3 article x 4 x 5 x x 6. Among them: * 1 for registered examination and approval department is located within the territory of the abbreviation: the third kind medical equipment, medical equipment and outside Taiwan, Hong Kong and Macao regions of medical devices for "nation" words, Within the second medical instrument for registration in the examination and approval departments of provinces, autonomous regions and municipalities abbreviation, Domestic class I medical devices for registered examination and approval department province, autonomous region, municipality directly under the central government where the level of district-constituted municipalities add referred to as the administrative area abbreviation, for x 1 (not corresponding the level of district-constituted municipalities administrative regions, only for the provinces, autonomous regions and municipalities directly under the central government abbreviation); X 2 for registration form (accurate, into, xu) : "quasi" the word is suitable for domestic medical devices, "Into" the word is applicable to foreign medical devices, "Make" the word is applicable to Taiwan, Hong Kong and Macao regions of medical devices, X subjcet 3 year for approval is registered, X 4 for product management category, X 5 for the variety of product coding, Subjcet x 6 for registered serial number. 2004 August 9 after the state food and drug supervision bureau issued registration number (national food regulators to 16) : clamps its X1 food developto XXXX3 first X4XX5XXXX6 spurt X2 words which X2 registered in the form of "quasi" "into" "xu" generally no "test" word, but also have exceptions, such as in transition, regulators entertained, food regulators examination and approval, can appear "test" word.