PART II | DUTIES AND OBLIGATIONS OF MANUFACTURERS, IMPORTERS, ETC., OF MEDICAL DEVICES |
| Duty to maintain records of supply |
4.—(1) Every manufacturer, importer or wholesaler of a medical device shall —| (a) | keep records of any supply made by him of the medical device; and | | (b) | produce such records for inspection by the Authority or an enforcement officer as and when required by the Authority or enforcement officer. |
(2) The records referred to in paragraph (1) shall —| (a) | contain the following information:| (i) | the proprietary name or description of the medical device that was supplied by the manufacturer, importer or wholesaler, as the case may be; | | (ii) | the date on which the medical device was so supplied; | | (iii) | the name and address of the person to whom the medical device was so supplied; | | (iv) | the quantity of the medical device so supplied; and | | (v) | the identification number or mark (including the control number, lot number, batch number or serial number) of the medical device so supplied; and |
| | (b) | be retained for the longer of the following periods:| (i) | the projected useful life of the medical device; or | | (ii) | 2 years after the date on which the medical device is so supplied to another person. |
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| (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)(b), furnishes the Authority or an enforcement officer with any record which he 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. |
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| Duty to maintain records of complaints |
5.—(1) Every manufacturer, importer or wholesaler of a medical device shall —| (a) | keep a record of every complaint received by him pertaining to the medical device; 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 record referred to in paragraph (1) shall —| (a) | contain the following information:| (i) | the proprietary name or description of the medical device that is the subject of the complaint; | | (ii) | the date on which the complaint was received; | | (iii) | the name and address of the complainant or, if unavailable, a unique identifier for the complaint; | | (iv) | the identification number or mark (including the control number, lot number, batch number or serial number) of the medical device; and | | (v) | the nature of the problem that is the subject of the complaint; and |
| | (b) | be retained for at least 5 years after the expiry of the projected useful life of the medical device. |
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| (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)(b), furnishes the Authority or an enforcement officer with any record which he 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. |
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| Reporting of defects and adverse effects |
6.—(1) For the purposes of section 42(1) of the Act, every manufacturer, importer or wholesaler of a medical device shall, upon becoming aware of any event or other occurrence that reveals any defect in the medical device or that concerns any adverse effect arising from the use thereof, report the event or occurrence to the Authority within the following period:| (a) | if the information relates to an event or other occurrence that represents a serious threat to public health — 48 hours after the manufacturer, importer or wholesaler first becomes aware of the event or occurrence; | | (b) | if the information relates to an event or other occurrence that has led to the death, or a serious deterioration in the state of health, of a patient, a user of the medical device or any other person — 10 days after the manufacturer, importer or wholesaler first becomes aware of the event or occurrence; | | (c) | if the information relates to an event or other occurrence a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the medical device or any other person — 30 days after the manufacturer, importer or wholesaler first becomes aware of the event or occurrence. |
(2) For the purposes of paragraph (1)(a), an event or other occurrence relating to a medical device represents a serious threat to public health if —| (a) | the event or other occurrence is a hazard arising from a systematic failure of the medical device that becomes known to the manufacturer, importer or wholesaler of the medical device; | | (b) | the event or other occurrence may lead to the death of, or a serious injury to, a patient, a user of the medical device or any other person; | | (c) | the existence of, probable rate of occurrence of, or degree of severity of harm caused by, the hazard was not previously known or anticipated by the manufacturer of the medical device; and | | (d) | it becomes necessary for the manufacturer of the medical device to take prompt action (including the recall of the medical device) to eliminate, or reduce the risk of, the hazard. |
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(3) For the purposes of paragraph (1)(b) and (c), an event or other occurrence leads to a serious deterioration in the state of health of a person if the event or other occurrence causes, or contributes to —| (a) | a life-threatening illness or injury suffered by that person; | | (b) | a permanent impairment of a bodily function of that person; | | (c) | any permanent damage to any part of the structure of the body of that person; or | | (d) | a condition requiring medical or surgical intervention to prevent such permanent impairment or damage. |
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| Notification to Authority concerning recall |
7.—(1) For the purposes of section 44(1) of the Act, every manufacturer, importer or wholesaler of a medical device shall, before carrying out the recall of a medical device, notify the Authority of the intended recall.| (2) The notification referred to in paragraph (1) shall be made in such form and manner as the Authority may require. |
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| Duty to furnish report on recall |
8.—(1) Every manufacturer, importer or wholesaler of a medical device shall —| (a) | within 24 hours from the commencement of the recall of a medical device, furnish to the Authority a preliminary report stating the reasons for the recall; and | | (b) | within 21 days from the date of the commencement of the recall or such longer period as the Authority may allow, furnish to the Authority a final report on the recall. |
| (2) The preliminary and final reports referred to in paragraph (1) shall be made in such form and manner and contain such information relating to the recall as the Authority may require. |
| (3) Any person who contravenes paragraph (1) 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 with any report which he 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. |
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