泰國醫(yī)療器械法規(guī)（Medical Devices Act, B.E.2551 (2008) and (No. 2), B.E. 2562 (2019)）規(guī)定，任何打算制造或進口醫(yī)療器械的人都應向許可授予人辦理機構注冊（establishment registration）。本文為大家介紹機構注冊證明書申請人要求，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)注冊申請人簽發(fā)用于制造或進口醫(yī)療器械的企業(yè)注冊證，前提是企業(yè)設立的申請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）是所尋求的機構注冊證明的業(yè)務的所有者;

 (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）在泰國有住所;

 (4) is not a bankrupt; 

（4）并非破產人;

 (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)定構成不誠實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，除非申請人在申請注冊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、儲存和控制或保持醫(yī)療器械質量的醫(yī)療器械和設備的銷售地或進口地，按照部長通知中規(guī)定的描述和編號;

 (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)務經營中，未使用與被吊銷營業(yè)執(zhí)照或吊銷營業(yè)執(zhí)照的機構注冊人在經營商業(yè)業(yè)務時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)本法被暫停機構注冊證的人;

 (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)本法撤銷過場所登記證，但在申請機構注冊之日前，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).

如果法人是機構注冊的申請人，則其負責業(yè)務運營的經理或代表應具有第（2）和第（3）項的資格，并且不受第（4）、（5）、（6）、（7）、（10） 或（11）項的禁止。

如有泰國醫(yī)療器械注冊咨詢服務需求，歡迎您隨時方便與杭州證標客醫(yī)藥技術咨詢有限公司聯(lián)絡，聯(lián)系人：呂工，電話：18058734169，微信同。