A few weeks ago, I had a meeting with overseas manufacturer to place on Korea medical device.
I inform the pre-check points to prepare on the initial development stage.

 

 

1.All the documents should be English or Korean. Or it needs translated

2.Class 1 device is not GMP audit area but it can be applied to GMP if needed.

3.Overseas manufacture address, company name should be exact.

4.Overseas Test reports for medical device registration should be tested in qualified test lab to meet the MFDS requirements.

5.For implantable device should be covered the Product Liability insurance

6.For GMP, on the Quality manual, it should be described such as Medical device Act Korea on the scope.

7.QMR should be designated on Korea importing company, if not, the medical device importing license cannot be acquired.

8.Some devices could not be a medial device scope, thus it should be check to MFDS Korea in advance.

9.Some medical device might be required the medical device clinical trials data.

10.All the process should be done local company in Korea.

11. Some devices can required the additional tests in Korea.
   (ex : Different voltage each country, 220V, 110V, 230V etc)

12. Recently, the device license renewal regulation established every 5 years.
   (similar as CE marking TF review)

13. In principle for GMP,
   1) new manufacturer – GMP audit required
   2) In case of many overseas manufacturers,
      - One manufacturer as representative (high class or quantities)
      - Others document audit

If you want to know more details, please email to chk3424@naver.com