Useful Information
How to Apply?
Applicant
According to section 7B(1) of the Human Organ Transplant Ordinance (Cap. 465) ("the Ordinance"), a person may apply for an exemption in respect of a regulated product by submitting an application to the Director of Health ("the Director").
If the applicant is not the manufacturer of the regulated product under application, a letter from the manufacturer to authorise the applicant to apply for an exemption is required.
Guidance Notes on Application for Exemption of Regulated Products
Detailed information on the legal requirements, application procedures and documents for exemption of regulated products under the Ordinance are set out in the Guidance Notes. A person who wishes to apply for an exemption in respect of a regulated product is recommended to read and follow the instructions in the Guidance Notes.
Submission of Application
The applicant should fill in all items of information requested in Application Form for Exemption of Regulated Products under the Human Organ Transplant Ordinance (Chapter 465), and provide supporting documents as specified in the application form.
The online form requires digital signature by either digital certificate or “iAM Smart”
For submission by post or by hand, the applicant should print and sign on the PDF application form with company chop (if applicable). Duly completed PDF application form and the required supporting documents should be submitted during office hours to the Department of Health ("the DH") at the following address:
| Address: |
Health Technology and Advisory Division Department of Health 21/F, Wu Chung House 213 Queen's Road East, Wanchai, Hong Kong |
|
Office hours- Mondays to Fridays (except public holidays): |
9:00 a.m. to 1:00 p.m.; and 2:00 p.m. to 5:30 p.m. |
Acknowledgement of Receipt
An acknowledgement will be issued to the applicant upon receipt of the application form and the required supporting documents. If the applicant does not receive the acknowledgement within 2 weeks after submission, he/she may contact us to check whether the submission has reached our office.
| Tel: | (852) 2961 8944 |
| Fax: | (852) 2127 7329 |
| Email: | hot_rpe@dh.gov.hk |
Offence
According to section 7B(7) of the Ordinance, any person who, in submission of application for exemption of regulated product, provides information that he/she 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.