10. Exception for non-clinical use

Without prejudice to any other provision in this Division, the prohibition in section 15(1) of the Act against the supply of an unregistered health product shall not apply to the supply of a medical device that is imported, supplied or used for a non-clinical purpose, if the requirements in paragraph (1A) are satisfied.

The requirements mentioned in paragraph (1) are that the person who supplies the unregistered medical device —

must —

hold an importer’s licence or a wholesaler’s licence for the unregistered medical device; or

be able to provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling, storage and distribution of the unregistered medical device as are necessary to prevent the deterioration of the medical device while it is in the applicant’s ownership, possession or control; and

must not supply that medical device to another person except with the Authority’s prior approval.

In paragraph (1), “non-clinical purpose” means any purpose other than a purpose described in paragraph (a) of the definition of “Medical device” in the second column of item 1 of the First Schedule to the Act.

Without prejudice to any other provision in this Division, the prohibition in section 15(1) of the Act against the supply of an unregistered health product shall not apply to the supply of a medical device that is imported, supplied or used for a non-clinical purpose, if the requirements in paragraph (1A) are satisfied.

The requirements mentioned in paragraph (1) are that the person who supplies the unregistered medical device —

must —

hold an importer’s licence or a wholesaler’s licence for the unregistered medical device; or

be able to provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling, storage and distribution of the unregistered medical device as are necessary to prevent the deterioration of the medical device while it is in the applicant’s ownership, possession or control; and

must not supply that medical device to another person except with the Authority’s prior approval.

In paragraph (1), “non-clinical purpose” means any purpose other than a purpose described in paragraph (a) of the definition of “Medical device” in the second column of item 1 of the First Schedule to the Act.