Medical Device Registration Vietnam

1. Medical Device Registration in Vietnam
20th July 2015

2. Medical Device Registration in Vietnam
 Regulatory Authority in Vietnam
• Department of Medical Equipment and Health Works (DMEHW) under Ministry
of Health (MOH)
 Main Legislation Document
• Circular No. 24/2011/TT-BYT issued by the Ministry of Health on 21 June 2011
regulates import of medical devices
• Circular No. 07/2002/TT-BYT issued by the Ministry of Health on 30 May 2002,
 guidance on registration for circulation of medical devices made in Vietnam.

3. Medical Device Registration in Vietnam
 Licensing Requirement
Establishment License
• Enterprise Registration
Certificate (Domestic Company)
• Investment Certificate (Foreign-
Invested Company)
Product License
• Import Permit (For certain
imported medical device)
• Circulation Registration Number
(For all locally manufactured
medical device)

4. Medical Device Registration in Vietnam
 Licensing Requirement
Establishment License
• Enterprise Registration Certificate
(Domestic Company)
• Investment Certificate
(Foreign-Invested
• License issue by Department
of Planning and Investment
• Company must be
incorporated & operating in
Vietnam

5. Medical Device Registration in Vietnam
Product License
• Import Permit (For certain
imported medical device)
• Circulation Registration
Number (For all locally
manufactured medical device)
• Medical device listed in the Appendix 1 of Circular
No. 24/2011/TT-BYT
• Medical device not listed, but
 Utilizes new methods of diagnosis/ treatment
 Imported into Vietnam for the first time
• Application form
• Enterprise Registration Certificate / Investment
Certificate
• ISO 13485/ISO 9001 Certificate
• Certificate of Free Sale / Certificate to Foreign
Government of FDA / CE-Marked Certificate
• Authorization letter
• Product catalogue
• Technical documentation
• Clinical trials report (For devices with new
diagnosis/therapy method or devices that are
imported to Vietnam for the first time)
Approve
Review
Import Permit
Valid for 1 year
Non-renewable

6. Medical Device Registration in Vietnam
Product License
• Import Permit (For certain
imported medical device)
• Circulation Registration
Number (For all locally
manufactured medical device)
• All locally manufactured medical device
• Application form
• Enterprise Registration Certificate
• Declaration of goods quality standard /
compliance with relevant quality standard
• 3 tests results
• Chemical, physical and safety test results
• Technical documentation and instruction manuals
• Product label
Approve
Review
Circulation Registration
Number
Valid for 3 year
Renew 30 days before expiry
15 working
days

7. Medical Device Registration in Vietnam
1 Grant of licenses for the import of medical
equipment and instruments:
Unit of
calculation
Fee (VND
1,000)
a Imported medical equipment valued at under
VND 1 billion
Commodity per
evaluation
500
b Imported medical equipment valued at between
VND 1 and 3 billion
Commodity per
evaluation
1,000
c Imported medical equipment valued at over VND
3 billion
Commodity per
evaluation
3,000
d Imported medical instruments Commodity per
evaluation
200
Evaluation for the grant of Circulation Registration Number
for medical equipment and instrument
Dossier 300

8. Thank You