泰国医疗器械法规（Medical Devices Act, B.E.2551 (2008) and (No. 2), B.E. 2562 (2019)）规定，任何打算制造或进口医疗器械的人都应向许可授予人办理机构注册（establishment registration）。本文为大家介绍机构注册证明书申请人要求，一起看正文。

根据Medical Devices Act, B.E.2551 (2008) and (No. 2), B.E. 2562 (2019)法规，

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: 

许可授予人可以向企业注册申请人签发用于制造或进口医疗器械的企业注册证，前提是企业设立的申请人显然符合以下条件：

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

（1）是所寻求的机构注册证明的业务的所有者;

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

（2）年龄不低于 20 周岁;

 (3) has a residence in Thailand; 

（3）在泰国有住所;

 (4) is not a bankrupt; 

（4）并非破产人;

 (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）从未因法律规定构成不诚实行为要素的罪行或本法规定的罪行而被终审判决判处监禁，除非申请人在申请注册日期前已获解除处罚超过两年;

 (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无行为能力的人或准无行为能力的人;

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

（7）没有部长通知中规定的疾病;

 (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、储存和控制或保持医疗器械质量的医疗器械和设备的销售地或进口地，按照部长通知中规定的描述和编号;

 (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）在商业业务经营中，未使用与被吊销营业执照或吊销营业执照的机构注册人在经营商业业务时使用的名称相同或相似的名称，且该名称已超过一年;

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

（10）不是根据本法被暂停机构注册证的人;

 (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）从未根据本法撤销过场所登记证，但在申请机构注册之日前，自撤销该证明书之日起已超过两年。

 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).

如果法人是机构注册的申请人，则其负责业务运营的经理或代表应具有第（2）和第（3）项的资格，并且不受第（4）、（5）、（6）、（7）、（10） 或（11）项的禁止。

如有泰国医疗器械注册咨询服务需求，欢迎您随时方便与杭州证标客医药技术咨询有限公司联络，联系人：吕工，电话：18058734169，微信同。