Suggest a correction

Duty to maintain records of use and disposal, etc., in relation to medical devices for clinical research

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) The sponsor referred to in regulation 36A(2) or (4) must —(a)maintain a record of the putting to some other use, disposal or export of a medical device under that provision; and(b)produce such record for inspection by the Authority or an enforcement officer as and when required by the Authority or enforcement officer.(2) The sponsor referred to in paragraph (1) must ensure that every record referred to in that paragraph —(a)contains all of the following information in relation to each medical device which is put to some other use, disposed of or exported:(i)the proprietary name or description of the medical device;(ii)the date on which the medical device was put to the other use, disposed of or exported;(iii)the name and address of the person responsible for the putting to the other use, disposal or export, of the medical device;(iv)the quantity of the medical device put to the other use, disposed of or exported;(v)the identification number or mark (including the control number, lot number, batch number or serial number) of the medical device; and(b)is retained —(i)for any registered medical device used in a regulated clinical trial or any medical device used in any clinical research that is not a regulated clinical trial, for 2 years after the time when the medical device is put to some other use, is disposed of or is exported, as the case may be; or(ii)for any unregistered medical device used in a regulated clinical trial, for the period for which records must be kept under regulation 23(2)(c) of the Health Products (Clinical Trials) Regulations 2016 (G.N. No. S 331/2016) or regulation 23(2)(c) of the Medicines (Clinical Trials) Regulations 2016 (G.N. No. S 335/2016), as the case may be.(3) Any person who contravenes paragraph (1) or (2) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 6 months or to both.(4) Any person who, in compliance or purported compliance with paragraph (1), furnishes the Authority or an enforcement officer with any record which the person knows is false or misleading shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both.

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.