Medical Device Registration in Vietnam

20th July 2015

Medical Device Registration in Vietnam

Regulatory Authority in Vietnam

• Department of Medical Equipment and Health Works (DMEHW) under Ministryof 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.

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)

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

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 yearNon-renewable

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 yearRenew 30 days before expiry

15 working days

Medical Device Registration in Vietnam

1 Grant of licenses for the import of medicalequipment and instruments:

Unit of calculation

Fee (VND 1,000)

a Imported medical equipment valued at underVND 1 billion

Commodity perevaluation

500

b Imported medical equipment valued at betweenVND 1 and 3 billion

Commodity perevaluation

1,000

c Imported medical equipment valued at over VND3 billion

Commodity perevaluation

3,000

d Imported medical instruments Commodity perevaluation

200

Evaluation for the grant of Circulation Registration Numberfor medical equipment and instrument

Dossier 300

Thank You