Medical Device Regulation - Cambodia

J

jasminelaw

Guest
#1
My questions are:
1) At this moment, is Medical Device Registration mandatory in Cambodia?
2) If yes,
a. what is the registration fee for Class A, B, C and D products respectively?
b. What is the product registration process ?
3) If not mandatory, then any indication that product registration will become mandatory?
 

sreenu927

Quite Involved in Discussions
#3
Hi Jasminelaw,

Yes. Regulations are implemented in Cambodia since Nov 2012. I got this information from one of the Industry association meetings that I had attended in Singapore, early this year. I don;t have the slides; however, below are the details:
- Registration is mandatory
- Classification based on GHTF - Class A, B, C & D; A being the low risk and D,the high risk
- For Class A, application form with FSC from Country of Origin, ISO 13485 Cert and authorization letter to your importer.
- For Class B, C & D, besides above, Common Submission Dossier has to be submitted with all test reports or summary of tests.
- Processing time: around 3 months
- Validity: 3 years

Also, take note that Cambodia is part of ASEAN Countries and ASEAN is planning to implement ASEAN Medical Device Directive w.e.f 2015. At this moment, first draft was released for comments from Industry and comments were provided.

Hope this helps!

Regards,
Sreenu
 
J

jasminelaw

Guest
#4
Thanks sreenu927.

Any idea what is the registration cost?

I was told by someone that Cambodia product registration is by size, and not by product group. and each size have to pay a separate registration fee. is that true?

what is the registration fee for each class of product respectively?
 
S

seeker1

Guest
#6
Hi Sreenu

Do you have any document regarding the import of medical devices to Cambodia. Is there any law/ regulation?
What is the process of registration currently (I suppose ASEAN Medical Device Directive is not enforced yet)
I am not able to find any related information on Ministry of Health portal. Please share if you have any reference links.

Thank you in advance
 
Last edited by a moderator:
#7
We are going through our first licensing process in Cambodia for Class A as an OEM. The sample authorization letter seems to be: (i) pharma and (ii) based upon the Japanese MAH model. Does anyone know whether MDs are separately regulated? What is the proper nomenclature for the manufacturer and distributor?

Bonus: Can we have more than one registration for our factory if we're selling under different brands?
 

Top