### Human Organ Transplant Ordinance 《人體器官移植條例》

6. Information about transplant operations
(1) The board may by regulation require such persons as may be prescribed to supply prescribed information to it with respect to transplants that have been or are proposed to be carried out using organs removed from dead or living persons.
(2) The board shall keep a record of information supplied to it in pursuance of the regulations made under this section.
(3) Any person who—
(a) without reasonable excuse fails to comply with regulations made under this section; or
(b) in purported compliance with regulations made under this section, knowingly or recklessly supplies information which is false or misleading in a material respect,

is guilty of an offence and is liable upon conviction to a fine at level 5 and to imprisonment for 3 months.

7. Restrictions on transplants of imported organs
(1) No person shall in Hong Kong transplant an imported organ into a recipient unless—
(a) the person who carries out the transplant is a registered medical practitioner;
(b) that organ, when imported into Hong Kong, is accompanied by a certificate that complies with all the requirements in subsection (2) except those that have been waived by the board under subsection (4); and
(c) that registered medical practitioner or another person who is acceptable to the board has supplied the original of that certificate or a copy of it to the board.
(2) The certificate for an imported organ mentioned in subsection (1)(b) must—
(a) be signed in the specified place by a person who is acceptable to the board; and
(b) contain the following—
(i) a statement that, in obtaining the organ, all applicable laws of the specified place were complied with;
(ii) a statement that, at the time the donor of the organ was tested in the specified place, he was not shown to be infected with any disease that was known, at the time of the testing, to be transmissible to the recipient of the organ through transplanting;
(iii) a statement that the organ was removed in a hospital in which the government of the specified place has authorized organs to be removed for transplanting;
(iv) a statement that no person in the specified place made or received a payment for supplying the organ; and
(v) such other information as the board may, by regulation, require to be supplied.
(3) For the purpose of subsection (2)(b)(v), the board may require different information to be supplied in relation to different organs.
(4) The board may, by notice in writing, waive any of the requirements in subsection (2) in any particular case if it considers it appropriate to do so in the circumstances.
(5) In subsection (2), specified place

### Human Organ Transplant Ordinance 《人體器官移植條例》

7A. Exemption of regulated products from this Ordinance
(1) For the purposes of this Part—
(a) regulated product (受規管產品) means a product containing any structured arrangement of tissues that—
(i) falls within paragraph (a)(iii) of the definition of organ

7B. How to apply for exemption
(1) A person may apply for an exemption in respect of a regulated product under this Part by submitting an application to the Director in a form specified by the Director.
(2) A form specified for the purpose of subsection (1) may require that—
(a) it be completed in a specified way;
(b) specified information be included in or attached to it; or
(c) it be submitted in a specified manner.
(3) If any requirement under subsection (2) is not complied with in relation to a form, the form is not properly completed.
(4) The Director may, by written notice, require an applicant to provide, within a reasonable period specified in the notice, additional information and documents as are reasonably necessary to enable the Director to determine the application.
(5) If such a requirement is not complied with, the Director may reject the application.
(6) When the Director is satisfied that the form of an application has been properly completed and all the information and documents he requires for determining the application have been submitted, he shall issue a written acknowledgment to the applicant confirming the receipt of the application.
(7) Any person who, in purported compliance with this section, provides information that he knows to be false or misleading in a material respect, or recklessly provides information that is false or misleading in a material respect, commits an offence and is liable on conviction to a fine at level 5 and to imprisonment for 3 months.

### Human Organ Transplant Ordinance 《人體器官移植條例》

7C. Determination of applications for exemption
(1) After considering an application for exemption under this Part, the Director may decide to approve the application and grant the exemption, or to reject the application.
(2) The Director shall give the applicant written notice of the decision by registered post.
(3) In approving an application for exemption, the Director may—
(a) limit the validity of the exemption to a specified period; or
(b) grant the exemption only to the applicant, a specified person or a specified class of persons.
(4) The Director may grant the exemption subject to such conditions as the Director considers appropriate, including a condition limiting the exemption only for a particular occasion or for the purpose of a specified type of transplant.
(5) On the breach of a condition imposed under subsection (4), the Director may—
(a) revoke the exemption concerned so that it shall have no effect either on the breach or from such date as the Director may determine;
(b) vary that exemption in such manner as the Director may determine; or
(c) suspend that exemption so that it shall have no effect for such period or until compliance with such other conditions as the Director may determine.
(6) A determination under subsection (5)(a), (b) or (c) may be made at the time the condition concerned is imposed under subsection (4) or breached.
(7) If an exemption granted by the Director is subject to any condition imposed under subsection (4), he shall specify that condition and the applicable consequence of its breach under subsection (5) in the written notice given under subsection (2).
(8) The Director may specify different consequences for the breach of different conditions under subsection (5). The Director may specify that a consequence shall apply generally or to the person who breaches the condition.
(9) If the Director rejects an application for exemption, he shall include in the written notice given under subsection (2) a statement setting out the reasons for the decision.

7D. Director’s power in relation to exemptions granted
(1) At any time after an exemption has been granted under this Part, the Director may, on such grounds as he considers appropriate—
(a) revoke the exemption so that it shall have no effect from such date as the Director may determine;
(b) vary the exemption in such manner as the Director may determine; or
(c) suspend the exemption so that it shall have no effect for such period or until compliance with such conditions as the Director may determine.
(2) The Director shall give the person to whom the exemption is granted a written notice of any decision under subsection (1) by registered post. The notice shall include a statement setting out the reasons for the decision.