Our Office is planning to issue a new Guidance Notes to cover the Listing of Local Responsible Persons (LRPs). The application for listing of LRP applies to entities intending to submit applications for listing their first medical device under the Medical Device Administrative Control System. Existing LRPs of listed medical devices do not need to apply for the listing.
In association with the issuance of the new Guidance Notes, the existing COP-01 Code of Practice for Local Responsible Persons will be updated.
Three briefing sessions with the same content but in different languages will be held. Details of the briefings are as follows:
Briefing Session No.1 (conducted in English) :
Date : 8 April 2019
Time : 2:15 p.m. to 3:15 p.m.
Venue: Lecture Hall, 3/F, Lam Tin Polyclinic, 99 Kai Tin Road, Lam Tin, Kowloon
Briefing Session No.2 (conducted in Cantonese) (FULL) :
Date : 8 April 2019
Time : 3:45 p.m. to 4:45 p.m.
Venue: Lecture Hall, 3/F, Lam Tin Polyclinic, 99 Kai Tin Road, Lam Tin, Kowloon
Briefing Session No.3 (conducted in Cantonese) :
Date : 8 April 2019
Time : 10:45 a.m. to 11:45 a.m.
Venue: Lecture Hall, 3/F, Lam Tin Polyclinic, 99 Kai Tin Road, Lam Tin, Kowloon
Enrolment is free. To enroll, please download and complete the enrolment form and submit it by fax to the Medical Device Control Office at (852) 3157 1286 or by email to mdco@dh.gov.hk on or before 1 April 2019.
The Guidance Notes and Code of Practice are now posted for comments. Briefing material is attached for reference.
Please send us your comment by fax (852) 3157 1286 or by email to mdco@dh.gov.hk on or before 18 April 2019.