Suggest a correction

Information to be provided with medical devices

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) For the purposes of section 18(1) of the Act, no person shall supply any medical device unless the following information accompanies the medical device when it is supplied:(a)the trade or brand name of the medical device;(b)where the medical device is supplied for use in any investigational testing, the statement “For Clinical Trial Use” or any other statement in English that conveys the same meaning;(c)[Deleted by S 318/2018 wef 01/06/2018](d)where the medical device is contained in a package and the contents of the package are not readily apparent, an indication of what the package contains, expressed in terms appropriate to the medical device, such as the size, net weight, length, volume or number of units;(e)the expiry date of the medical device, if the medical device has one, as determined by the product owner of the medical device on the basis of the component of the medical device that has the shortest projected useful life; (f)the product owner’s name or trading name, address, telephone number and electronic mail address;(g)an appropriate control number, such as a batch code, lot number or serial number.(2) The information mentioned in paragraph (1) must be provided in the manner specified on the Authority’s website.

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.