Tsamaiso ea Tsamaiso ea Lijo le Lithethefatsi ea China e lokolitse mofuta o mocha oa "Lethathamo la Khethollo ea Lisebelisoa tsa Meriana" e sebetsang ho tloha ka la 1 Phato 2018.

Ka la 4 Loetse 2017, Tsamaiso ea Naha ea Lijo le Lithethefatsi (eo ka mor'a moo e bitsoang "Tsamaiso e Akaretsang") e ile ea tšoara seboka sa boralitaba ho lokolla ka molao "Classification Catalog for Medical Devices" (eo hamorao e tla bitsoa "New Classification Catalog". ”).E sebetsa ho tloha ka la 1 Phato 2018.

Tsamaiso ea likarolo tsa lisebelisoa tsa bongaka ke mohlala oa tsamaiso o amoheloang ke machaba, 'me ho aroloa ha lisebelisoa tsa bongaka tsa saense le tse utloahalang ke motheo oa bohlokoa oa tlhokomelo ea ts'ebetso eohle ea ho ngolisa, tlhahiso, ts'ebetso le tšebeliso ea lisebelisoa tsa bongaka.

Hajoale, ho na le litifikeiti tse ka bang 77,000 tsa ngoliso ea lisebelisoa tsa bongaka le litifikeiti tse fetang 37,000 tsa ngoliso ea lisebelisoa tsa bongaka China.Ka tsoelo-pele e potlakileng ea indasteri ea lisebelisoa tsa bongaka le ho hlaha ho tsoelang pele ha theknoloji e ncha le lihlahisoa tse ncha, tsamaiso ea lihlopha tsa lisebelisoa tsa bongaka ha e khone ho finyella litlhoko tsa nts'etsopele ea indasteri le mosebetsi oa taolo.Phetolelo ea 2002 ea "Medical Classification Catalog" (eo ka mor'a moo e bitsoang "Classification Catalog" ea pele) Mefokolo ea indasteri e se e totobala le ho feta: Taba ea pele, "Catalog" ea mantlha ha e na lintlha tse lekaneng, 'me moralo ka kakaretso le boemo ba boemo ha li khone ho fihlela maemo a hajoale a indasteri le litlhoko tsa taolo.Ea bobeli, "Catalogue" ea mantlha e ne e se na tlhahisoleseling ea bohlokoa joalo ka tlhaloso ea sehlahisoa le ts'ebeliso e reriloeng, e ileng ea ama ho ts'oana le maemo a tumello ea ngoliso.Ntlha ea boraro, "Category Catalog" ea pele e ne e le thata ho koahela lihlahisoa tse ncha le lihlopha tse ncha.Ka lebaka la khaello ea mokhoa o matla oa ho lokisa, litaba tsa lethathamo la libuka ha lia ka tsa ntlafatsoa ka nako, 'me karohano ea sehlopha sa lihlahisoa e ne e sa utloahale.

E le ho kenya ts'ebetsong "Melao ea Tlhokomelo le Tsamaiso ea Lisebelisoa tsa Bongaka" e ntlafalitsoeng le e phatlalalitsoeng ke Lekhotla la Naha le "Maikutlo a Lekhotla la Naha mabapi le ho Fetola Tsamaiso ea Tlhahlobo le Kamohelo ea Lithethefatsi le Lisebelisoa tsa Bongaka", Lijo le Lithethefatsi tsa Naha. Tsamaiso e akaretsa le ho hlahlobisisa lisebelisoa tsa bongaka tse fanoeng ho theosa le lilemo ho latela phepelo ea lintlafatso tsa taolo ea lisebelisoa tsa bongaka.Lifaele tsa ho hlophisoa ha lisebelisoa le litlhaloso, ho hlophisa lintlha tsa lihlahisoa tse nepahetseng tsa ngoliso ea lisebelisoa tsa bongaka, le ho etsa lipatlisiso ka tsamaiso ea lisebelisoa tsa bongaka tse ts'oanang tsa kantle ho naha.Mosebetsi oa ntlafatso o ile oa thakholoa ka Phupu 2015, 'me ntlafatso ea kakaretso le tokiso ea moralo, sebopeho le litaba tsa "Classification Catalog" li ile tsa etsoa.Theha Komiti ea Botekgeniki ea Phapang ea Lisebelisoa tsa Bongaka le sehlopha sa eona sa litsebi, e bonts'itse ka mokhoa o hlophisehileng boitseanape le ho utloahala ha litaba tsa "Classification Catalog", le ho ntlafatsa "Classification Catalog" e ncha.

"Category Catalog" e ncha e arotsoe ka lihlopha tse nyenyane tsa 22 ho ea ka litšobotsi tsa theknoloji ea lisebelisoa tsa bongaka le tšebeliso ea meriana.Likaroloana li entsoe ka mekhahlelo ea lihlahisoa tsa boemo ba pele, mekhahlelo ea lihlahisoa tsa boemo ba bobeli, litlhaloso tsa lihlahisoa, ts'ebeliso e reriloeng, mehlala ea mabitso a lihlahisoa le lihlopha tsa tsamaiso.Ha ho khethoa sehlopha sa sehlahisoa, ho lokela ho etsoa qeto e felletseng ho latela boemo ba 'nete ba sehlahisoa, ho kopantsoe le tlhaloso ea sehlahisoa, tšebeliso e reriloeng le mehlala ea mabitso a sehlahisoa "Catalog" e ncha.Likarolo tse ka sehloohong tsa "Catalogue" e ncha ke tse latelang: Ntlha ea pele, sebopeho se na le saense haholoanyane 'me se lumellana le mekhoa ea bongaka.Ho latela lithuto ho tsoa ho sistimi e ikhethileng ea ts'ebeliso ea bongaka United States, e bua ka sebopeho sa "Framework Catalog for Notified Bodies of the European Union", likaroloana tse 43 tsa "Classification Catalog" ea hajoale e kopantsoe ho ba 22. dikarolo tse nyane, le dikarolo tse 260 tsa dihlahiswa di ntlafaditswe le ho lokiswa ho ya ho mekgahlelo e 206 ya dihlahiswa tsa boemo ba pele mme dihlopha tse 1157 tsa boemo ba bobedi di bopa sehlopha sa maemo a mararo a lethathamo la dihlahiswa.Ea bobeli, tšireletso e pharaletseng, e ruta le ho sebetsa.Ho ekelitsoe lihlahisoa tse ncha tse fetang 2,000 bakeng sa tšebeliso e lebeletsoeng le litlhaloso tsa lihlahisoa, 'me "Catalog" ea morao-rao e ekelitsoe ho mehlala ea 6,609 ea mabitso a lihlahisoa tsa 1008.Ea boraro ke ho lokisa mekhahlelo ea taolo ea lihlahisoa ka mokhoa o utloahalang, ho ntlafatsa ho ikamahanya le maemo ha maemo a teng indastering le tlhokomelo ea 'nete, le ho fana ka motheo oa ho ntlafatsa kabo ea lisebelisoa tsa tlhokomelo.Ho ea ka tekanyo ea kotsi ea sehlahisoa le tlhokomelo ea sebele, sehlopha sa tsamaiso ea lihlahisoa tse 40 tsa lisebelisoa tsa bongaka tse nang le nako e telele ea ho rekisoa, kholo e phahameng ea lihlahisoa le likotsi tse laolehang li fokotsehile.

Moralo le litaba tsa "Classification Catalog" e ncha li fetotsoe haholo, tse tla ba le tšusumetso likarolong tsohle tsa ho ngolisa lisebelisoa tsa bongaka, tlhahiso, ts'ebetso le tšebeliso.Bakeng sa ho netefatsa kutloisiso e kopaneng ea mekha eohle, phetoho e thellang, le ts'ebetsong e hlophisehileng, Tsamaiso ea Lijo le Lithethefatsi ea Naha ka nako e le 'ngoe e ile ea ntša le ho kenya ts'ebetsong "Tsebiso mabapi le ho Kenngwa Tshebetsong ha Ntlafatso e Ntjha”, ho fana ka nako e ka etsang selemo ea ho kenya tšebetsong nako ea phetoho.Ho tataisa balaoli ba tsamaiso le likhoebo tse amanang le tsona ho kenya tšebetsong.Mabapi le tsamaiso ea ho ngolisa, ho nahanisisa ka botlalo boemo ba indasteri ea lisebelisoa tsa bongaka, ho amohela mocha oa phetoho ea tlhaho ho kenya ts'ebetsong "Classification Catalog" e ncha;bakeng sa tlhokomelo ea ka mor'a 'maraka, tlhahiso le ts'ebetso ea ts'ebetso li ka amohela mekhoa e mecha le ea khale ea li-coding system ka ho tsamaisana.Tsamaiso ea Naha ea Lijo le Lithethefatsi e tla hlophisa koetliso ea tsamaiso eohle ho "Classification Catalog" e ncha le ho tataisa balaoli ba taolo ea lehae le lik'hamphani tsa tlhahiso ho kenya tšebetsong "Classification Catalog" e ncha.

2018 lethathamo le lecha la lihlopha tsa lisebelisoa tsa bongaka Mohloli oa litaba: Tsamaiso ea Lijo le Lithethefatsi ea Chaena, http://www.sda.gov.cn/WS01/CL0051/177088.html


Nako ea poso: Mar-02-2021