泰國(guó)醫(yī)療器械法規(guī)（Medical Devices Act, B.E.2551 (2008) and (No. 2), B.E. 2562 (2019)）規(guī)定，任何打算制造或進(jìn)口醫(yī)療器械的人都應(yīng)向許可授予人辦理機(jī)構(gòu)注冊(cè)（establishment registration）。本文為大家介紹機(jī)構(gòu)注冊(cè)證明書申請(qǐng)人要求，一起看正文。

根據(jù)Medical Devices Act, B.E.2551 (2008) and (No. 2), B.E. 2562 (2019)法規(guī)，

Section 16. The permission grantor may issue an establishment registration certificate, for the manufacture or import of medical devices, to the applicant for the establishment registration when it is apparent that the applicant for the establishment: 

許可授予人可以向企業(yè)注冊(cè)申請(qǐng)人簽發(fā)用于制造或進(jìn)口醫(yī)療器械的企業(yè)注冊(cè)證，前提是企業(yè)設(shè)立的申請(qǐng)人顯然符合以下條件：

 (1) is the owner of the business in respect of an establishment registration certificate is sought;

（1）是所尋求的機(jī)構(gòu)注冊(cè)證明的業(yè)務(wù)的所有者;

 (2) is of not lower than twenty years of age; 

（2）年齡不低于 20 周歲;

 (3) has a residence in Thailand; 

（3）在泰國(guó)有住所;

 (4) is not a bankrupt; 

（4）并非破產(chǎn)人;

 (5) has never been sentenced to imprisonment by a final judgment for an offence which is provided by law to be constituted by an element of a dishonest act or for an offence under this Act, unless the applicant has been discharged from the penalty for more than two years prior to the date of the application for registration;

（5）從未因法律規(guī)定構(gòu)成不誠(chéng)實(shí)行為要素的罪行或本法規(guī)定的罪行而被終審判決判處監(jiān)禁，除非申請(qǐng)人在申請(qǐng)注冊(cè)日期前已獲解除處罰超過兩年;

 (6) is not a person of unsound mind or an incompetent person or a quasiincompetent person;

（6）不是心智不健全的人或無行為能力的人或準(zhǔn)無行為能力的人;

 (7) does not have diseases as prescribed in the Notification of the Minister;

（7）沒有部長(zhǎng)通知中規(guī)定的疾病;

 (8) has places of manufacture or places of import of medical devices and equipment used for the manufacture, storage and control or preservation of the quality of medical devices, in accordance with such descriptions and number as prescribed in the Notification of the Minister; 

（8）具有用于制造、儲(chǔ)存和控制或保持醫(yī)療器械質(zhì)量的醫(yī)療器械和設(shè)備的銷售地或進(jìn)口地，按照部長(zhǎng)通知中規(guī)定的描述和編號(hào);

 (9) does not use the name, in the operation of commercial business, which is identical or similar to any name used in the operation of commercial business of the establishment registrant who is under suspension of an establishment registration certificate or revocation of an establishment registration certificate, when less than one year has elapsed therefrom;

（9）在商業(yè)業(yè)務(wù)經(jīng)營(yíng)中，未使用與被吊銷營(yíng)業(yè)執(zhí)照或吊銷營(yíng)業(yè)執(zhí)照的機(jī)構(gòu)注冊(cè)人在經(jīng)營(yíng)商業(yè)業(yè)務(wù)時(shí)使用的名稱相同或相似的名稱，且該名稱已超過一年;

(10) is not a person who is under suspension of an establishment registration certificate under this Act; 

（10）不是根據(jù)本法被暫停機(jī)構(gòu)注冊(cè)證的人;

 (11) has never had an establishment registration certificate revoked under this Act except that more than two years have elapsed since the revocation thereof prior to the date of the application for registration of an establishment.

（11）從未根據(jù)本法撤銷過場(chǎng)所登記證，但在申請(qǐng)機(jī)構(gòu)注冊(cè)之日前，自撤銷該證明書之日起已超過兩年。

 In the case where a juristic person is an applicant for registration of an establishment, its manager or representative in charge of the operation of the business shall have the qualifications under (2) and (3) and be under no prohibitions under (4), (5), (6), (7), (10) or (11).

如果法人是機(jī)構(gòu)注冊(cè)的申請(qǐng)人，則其負(fù)責(zé)業(yè)務(wù)運(yùn)營(yíng)的經(jīng)理或代表應(yīng)具有第（2）和第（3）項(xiàng)的資格，并且不受第（4）、（5）、（6）、（7）、（10） 或（11）項(xiàng)的禁止。

如有泰國(guó)醫(yī)療器械注冊(cè)咨詢服務(wù)需求，歡迎您隨時(shí)方便與杭州證標(biāo)客醫(yī)藥技術(shù)咨詢有限公司聯(lián)絡(luò)，聯(lián)系人：呂工，電話：18058734169，微信同。