Suggest a correction

Duty of importer

Health Products (Medical Devices) Regulations 2010

Match the official source exactly.

What needs fixing?

Wrong or mistyped textWrong structure or numberingWrong title or detailsDuplicated content

Proposed text

—(1) Despite any other provision in this Part, an importer of a medical device —(a)must ensure, and maintain objective evidence to establish, that the medical device complies with the safety and performance requirements for the medical device set out on the Authority’s website;(b)must provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling and storage of the medical device as are necessary to prevent the deterioration of the medical device while it is in the importer’s ownership, possession or control;(c)if the importer is the holder of an importer’s licence for the medical device —(i)must, if required under these Regulations, ensure, and maintain objective evidence to establish that, the handling and storage of the medical device complies with the requirements of the Good Distribution Practice Standard for Medical Devices or ISO 13485; and(ii)must not use, for any purpose mentioned in sub‑paragraph (b), any premises other than the premises specified in the licence, or any other premises that the Authority may approve from time to time; and(d)must import only medical devices that are authorised to be imported by —(i)the registrant of the medical device;(ii)the product owner of the medical device; or(iii)any other person approved by the Authority.(2) Paragraph (1)(d) does not apply to the import of any medical device in accordance with regulation 4C.

What's the problem? (required)

Source link (optional)

Describe the problem (and edit the text or pick an issue type) to submit.

Suggestions are submitted anonymously. No account or personal information is required or sent.