Ministry of Food and Drug Safety Notice No. 2014-155 was published on MFDS website. The Korean Good Manufacturing Practice (KGMP) being revised and this is a public consultation. South Korea medical device registration will be affected by this publication.
The purpose here is clearly to improve the way KGMP is managed.
Below is a summary of what the publication is about.
The term “evaluation of conformity” was changed to “conformity compliance”. The inspection definition is updated by distinguishing “initial” and “follow-up” inspections.
Re-schedule of the Korean KGMP inspection
Under the current regulation, importers and manufacturers have to notify any change in scheduling less than 37 days after requesting the inspection. In the future, the preliminary control over inspection schedule will be improved in such a way that the whole process will be smoother and irregular practice will be eliminated.
3rd Party Review
MFDS acknowledge the fact that due to its limited manpower, third party inspectors have to be involved. The differentiation of the entity performing the inspection will be made depending on the class of the product. MFDS will concentrate on high risk products.
3rd party inspection shall be performed only in the case of class 2 products.
In the case of low risk medical devices and those devices having a high GMP inspection rate (60%). However joint inspection with KGMP will take place in case the manufacturer has quality concerns.
Simplification of the submitted data for KGMP inspection
So far the Device Master Record (DMR) was submitted for each product along with the site preliminary data in the case of : initial, additional, modification inspection (except follow-up). This results in a lot of resources required when preparing the material.
The regulation will be simplified by aligning the data submitted in the case of initial, additional, modification to the data submitted in the case of follow-up inspection. The DMR is to be submitted for a representative product per product group.
Notification details for the KGMP inspection
On the KGMP certificate product group and product name both appear currently even though the KGMP inspection is done for one product group. Whenever a product belongs to a specific group but not listed on the certificate, it is mistaken for a product not having been inspected, giving difficulties for companies during sales. Therefore it is planned to indicate only the product group on the KGMP certificate.
Validity period of the KGMP certificate
KGMP inspection is performed with 3 year cycle and the effective date for the compliance certificate is calculated to be 3 years from the issuing date. Most manufactures/importers request KGMP inspection 90 days before expiration date and receive KGMP inspection before the expiration date in order not to affect the sales. An inequality of the remaining effective dates expiring exists because the compliance certificate effective date is recalculated from the issuing date.
The companies that pro actively participate in KGMP system are no longer disadvantaged by adjusting the regulation on calculating the effective date on the KGMP certificate from issuing date to expiration date.
Issuing and managing KGMP certificates
A rule is defined in order to clarify the standard, management method and details to be recorded regarding the issuing of the KGMP certificate.
Self management of KGMP compliance certificate
There is a problem of separately remitting the fee and reissuing the compliance certificate or the necessity of companies even though it is not subject to KGMP inspection with regards to modifying details such as changing the manufacturer’s name and the representative.
To simplify the process companies will be allowed to independently manage minor details that are not subject to KGMP inspection such as modification of manufacturer’s name or representative.
Quality Manager and training facility
Provisions already exist regarding the details of the adoption of quality manager for the importer. Details such as designation, standard, evaluation method, training content and requirement for the training facility of the quality manager are defined.
If you wish to sell in South Korea you can contact us for a preliminary discussion. See also our services for the registration of medical devices in South Korea.