Vietnam - Authorized Medical Device Representative Change

celticfrosting

Starting to get Involved
#1
Hello, the company that I work for exports US Class I and II medical devices to Vietnam. We have an authorized representative that distributes for us there. We want to discontinue them as our representative. In doing so how will we be affected? Can said registration be held by another company or a third-party agency? Ideally, we do not want to re-register all over again. Thank you.
 
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celticfrosting

Starting to get Involved
#2
I should note that we have not been issued with marketing authorization (MA) numbers for our devices. We were registered in Vietnam up until the deadline of Decree No. 36/2016/ND-CP on December 31, 2017.
 
#3
Medical Device Registration in Vietnam | Andaman Medical

I don't think their information will directly answer your question but maybe it is a start.

http://www.tilleke.com/sites/default/files/2012_Nov_JMDR_Vietnam_Overview.pdf (PDF warning!)

This article from my former law firm shows that the product registration is tied to the importer of record but doesn't go into details about any sort of transfer process. In Indonesia, for example, some changes to medical device licenses are allowed by way of amendment but others require re-issuances. So you may be facing a re-issue situation.

We have subsidiary in Vietnam that acts as our representative, so I can't help you from my direct experience. Sorry and good luck!
 

jon.loo

Starting to get Involved
#4
Decree 36's implementation for Class BCD devices (based on AMDD classification) had been postponed to 1st Jan 2019, while Class A devices are already enforced.
For Class A, you will require re-registration but the registration requirement is extremely easy so it should not be a worry.
For Class BCD, it will be advisable to get your new distributor to start registering the device under decree 36 for the new cut-in or even get a licence holder.
 

celticfrosting

Starting to get Involved
#5
Decree 36's implementation for Class BCD devices (based on AMDD classification) had been postponed to 1st Jan 2019, while Class A devices are already enforced.
For Class A, you will require re-registration but the registration requirement is extremely easy so it should not be a worry.
For Class BCD, it will be advisable to get your new distributor to start registering the device under decree 36 for the new cut-in or even get a licence holder.
Thank you for the information.

How would I find out what classification our product falls under in Vietnam? Our products are US Class I and II, EU Class IIa and IIb.

From a regulatory point of view, if my company's products fall under classes B, C or D how easy is it to register with a new company as opposed to staying with our current distributor/holder? Are they both the same process and length even if I have already established prior registration falling under Circular No 30/2015/TT-BYT? Ideally I would like to change to another distributor/holder. I'm trying to assess the path of least resistance.
 

jon.loo

Starting to get Involved
#6
@celticfrosting - You can read up on the AMDD (Asean Medical Device Directive). The classification is almost identical to the EU MDD (less so for MDR). If your device is already registered in Singapore, it will greatly help as the early batch of Viet regulators were trained by Singapore on classification using the AMDD risk classification rules.
 

celticfrosting

Starting to get Involved
#7
Yes, we are registered in Singapore. We will most likely keep the existing registration (under Circular No 30/2015/TT-BYT) with our present holder, but in that time seek and establish registration (under Decree No. 36/2016/ND-CP) with a new partner.
 
#8
Yes, we are registered in Singapore. We will most likely keep the existing registration (under Circular No 30/2015/TT-BYT) with our present holder, but in that time seek and establish registration (under Decree No. 36/2016/ND-CP) with a new partner.
Via Decree No.36/2016/ND-CP for VietNam Medical Devices managerment. You can hold licences by your Representative Office in VietNam, then you issue authorized letter to your distributors to use your free sales licences (class A, B, C, D) to import and trading. This is a new point of new rule.
Via Decree No.169/2018/ND-CP, all import licence (issued under Circular 30/2015/TT-BYT) will expired on 31 Dec 2019. From 2020, all medical devices (class A, B, C, D) have to use free sales (FSC) to import.

Hello, the company that I work for exports US Class I and II medical devices to Vietnam. We have an authorized representative that distributes for us there. We want to discontinue them as our representative. In doing so how will we be affected? Can said registration be held by another company or a third-party agency? Ideally, we do not want to re-register all over again. Thank you.
The strategy to discontinue your local partner is: just issued 1 year LOA
1 product can be register by many local distributor to get domestic FSC (valid 5 years)
 

Murni Ahmad

Involved In Discussions
#9
Hi All,

I am trying to outline the documentation for the importation of medical devices into Vietnam, as follows,

1. Letter of Authorization (quoted from ANNEX VI of Decree No. 36/2016/NĐ-CP dated May 15, 2016)
2. Certificate of Local Service Center (not sure where this requirement quoted from)​
3. Free Sales Certificate (FSC) from the country of origin (need to be legalized and notarized by Vietnam embassy)​
- Will Vietnam authority accepts a legalized and notarized of the FSC copy? (not the original copy, trying to cut the cost applying multiple FSC for another SEA country)
- Any other document can replace FSC, can an EC certificate or Certificate of Conformity, or Chamber of Commence replace FSC?
4. ISO 13485
- Will Vietnam authority accepts the softcopy? Does this document need to be legalized and notarized? Can we do it on a copy and not the original certificate? (same reason to cut cost)
5. Catalogue and Product data (assuming they will accept either CSDT, manual or IFU)​
- what are the details they needed in this product data? can CSDT fulfill this requirement?​
Anyone experience handling the import documentation in Vietnam? What is the current status and projected timeline on the import license, registration? Maybe I should create another topic specifically on Vietnam medical device regulation,
 
#10
Hi Murni Ahmad,

This link I posted some time ago may answer some of your questions:

http :// www .tilleke. com /sites/default/files/2012_Nov_JMDR_Vietnam_Oerview.pdf - DEAD LINK

I generally do a lot of work in Vietnam but not with medical devices anymore - they are very strict so I doubt they will accept copies or otherwise deviate from the requirements, but this also depends upon your distributor's skills and experience. If your other SEA country is Thailand (where I'm located), then they're also pretty strict about the documentation (and also not a member of the Hague Apostille Convention).

Hope this is somewhat helpful.
 
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