medical device

Question 1

need manu license if develop lab test for clinical lab or blood banking?

Answer 1

no

Question 2

record of manu keep how long

Answer 2

projected useful life of medical device OR 2y after date which device is supplied to another person

Question 3

keep complaints for how long

Answer 3

at least 5y after expiry of projected useful life

Question 4

report in how many days when licensee receives info on bad quality of device

Answer 4

within 15d

Question 5

furnish report on recall when

Answer 5

no latet than 21st day after recall date

Question 6

class A med device need register?

Answer 6

nope but need notify, BCD yes

r10B
r15 part 7, r25

Question 7

what is SS620

Answer 7

singapore standard for good distribution practice for med devices

Question 8

reporting of defects and adverse effects
- serious threat
- led to death
- might lead to death

Answer 8

48h
10d
30d

Question 9

furnish report on field safety corrections by

Answer 9

21st day after the date of field safety corrective action