31 Duty of licensees, suppliers and registrants to comply with enforcement orders

32 Duty to comply with conditions of licence or registration

33 Duty of manufacturer

34 Duty of importer

35 Duty of wholesaler

35A Duty of supplier of unregistered Class A medical devices to furnish information

36 Duty of registrant to ensure compliance with safety and performance requirements

36A Duties of sponsor, etc.

37 Offence for contravention of duties

38 Duty to maintain records of manufacture

39 Duty to maintain records of supply

39A Duty to maintain records of receipt and supply in relation to medical devices for clinical research

39B Duty to maintain records of use and disposal, etc., in relation to medical devices for clinical research

40 Qualified practitioners to maintain records of implantable medical devices

41 Duty to maintain records of complaints

42 Reporting of defects and adverse effects

43 Reporting of information adversely affecting quality, safety or efficacy of medical device

44 Notification to Authority concerning recall

45 Duty to furnish report on recall

46 Notification to Authority concerning field safety corrective action

47 Duty to furnish report on field safety corrective action

48 Changes affecting licence

49 Changes concerning registered medical device