KOREA CHANGES MEDICAL DEVICE QUALITY SYSTEM REQUIREMENTS

The Korean Ministry of Food and Drug Safety (MFDS) announced changes to the requirements for Korea Good Manufacturing Practice (KGMP) certification.  Any company applying for new or renewal KGMP certificates after July 1, 2019 will be subject to the following new requirements:

  1. KGMP reference standard will be changed from ISO 13485:2003 to ISO 13485:2016
    • While certification to the standard is not required, quality systems must demonstrate compliance to the same
  2. On-site inspection of contract manufacturing sites will increase
    • The provision requiring only one contract manufacturer to be subject to an on-site inspection has been eliminated. Formerly, when a legal manufacturer employed two or more contracting manufacturers, an on-site auditing would be conducted to one contract manufacturing site and the other sites would only be subject to document audits. This change has the potential to add significant time and cost to the compliance requirements for manufacturers that employ multiple outsourced manufacturing facilities.
  3. Additional documents will be made mandatory for KGMP application
    • Several documents have been added to the certification application aimed at closing the gap between paper audit and on-site audit requirements. The MFDS is expected to provide guidance on the format for items 5 and 6 before July 1, 2019. The additional documents are:
1Organization chart
2Document log listing the quality documents
(document name an revision information must be identifiable)
3Quality control summary
4Declaration of conformity
5Summary of Validation of Processes for Providing Production and
Services related to the product for KGMP certification
6Summary of Control of Monitoring and Measuring Equipment
related to the product for KGMP certification

Korea has a unique quality system assessment process for medical device manufacturers.  Since April of 2012, KGMP certificates are a required element of Class 2, 3 and 4 medical device registration applications for foreign manufacturers. Certificates are product category, facility and license holder specific; and must be renewed every three years. Certificates are required for the legal manufacturing site as well as any contract manufacturing site involved with a critical manufacturing process.

Medical device manufacturers active or interested in the Korean market should be prepared for these changes.

Contact us!

Asia Actual has a strong regulatory team in Seoul to help device manufacturers stay informed and compliant with regulatory changes. Please contact us with questions or support requests.

Korea Announces Plans for Unique Device Identification (UDI) Requirements Starting in 2019

The Korean Ministry of Food and Drug Safety (MFDS) published a draft amendment to the Medical Device Act that mandates a new Management System for Controlling Medical Device Information (MCMI) to record information on the overall life cycle of the medical devices from manufacturing to end-use.

When implemented, manufacturers or importers must input the following information into the MCMI prior to product release into the Korean market:

  1. UDI (Unique Device Identification) of each model
  2. Basic information of the model
  3. Information on the manufacturer and importer
  4. Miscellaneous information required by applicable MFDS notification

Implementation deadlines are assigned by risk classification starting with high-risk Class 4 devices on January 1, 2019; followed by Class 3 device on January 1, 2020; Class 2 device on January 1, 2021; and finally Class 1 devices on January 1, 2022.

Manufacturers or importers are responsible to keep MCMI information up to date for three years from the date of ceasing product sales in Korea.

MEDICAL DEVICE REGISTRATION FEES INCREASE IN KOREA

The Korean government increased fees charged by the Ministry of Food and Drug Safety (MFDS) and Medical Device Information and Technology Assistance Center (MDITAC) for processing medical device conformity assessment applications in May of 2017.  Fees are now US$1,000 for a Safety and Efficacy Review (SER) and US$500 for a Substantial Equivalent (SE) review. Processing fees for a device license amendment will be increased to US$700 for an SER device and US$400 for an SE device.

Official fees for Class 2 technical document review and KGMP certification will maintain at the same level, but the official fees for Class 1 devices and for minor changes will increase slightly (by US$3/application).

Korea Intends to Increase Medical Device Registration Fees in 2017

The Korean government has announced intentions to increase the official fees charged by the Ministry of Food and Drug Safety (MFDS) and Medical Device Information and Technology Assistance Center (MDITAC) for processing medical device conformity assessment applications. Fees will more than double to US$1,000 for a Safety and Efficacy Review (SER) and US$500 for a Substantial Equivalent (SE) review. Processing fees for a device license update will be increased similarly.

Official fees for Class 2 technical document review and KGMP certification will maintain at the same level, but the official fees for Class 1 devices and for minor changes will increase slightly (by US$3/application).

The new fees schedule is expected to take effect in the first half of 2017.

4 Product Development Decisions that Impact Sales Performance in Asia

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US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.

Incorporate Asian Requirements into Product Testing
Conformance testing certificates are a common element of medical device registration applications. In most Asian regulatory systems, test reports used for US and European device registration are sufficient, with notable exceptions. South Korea and other markets require CB Scheme certification for electrical safety testing certificates. Further, testing records should be generated based on a country’s electrical supply (e.g., 220V/60Hz and/or 380V/60Hz). In Indonesia, Certificates of Analysis require numeric test values as well as a pass/fail designation. In China, in addition to having a complete set of test certificates to international standards, registration of Class II and III devices will require test certificates generated from one of ten local CFDA-certified test laboratories.

Design Your Clinical Trial to include Asian Requirements
If you must conduct a clinical trial in support of FDA Approval or CE Marking, confirm the data generated will also be acceptable for device registration in Asia. The Pharmaceutical and Medical Devices Agency in Japan offers a Clinical Trial Consultation just for this purpose. You may also consider the Harmonization by Doing program in Japan, which is designed to reduce the cost and time to register novel devices significantly by shifting 25% of your patient sample from a US clinical trial to Japan. The CSCSO in India will generally accept clinical data from outside India (except for drug-eluting stents, etc.), but may want to see ethnicity data. Again, Chinese registration of Class II and III devices will require a limited local clinical trial data.

Select a Fully Recognized Notified Body
Pick an ISO 13485 Registrar and CE Mark Notified Body that is recognized by competent authorities in Asia to avoid redundant QMS inspections and product conformity assessment fees. The Australian government has a mutual recognition treaty with the European Union whereby medical devices with CE Mark avoid local conformity assessment, greatly accelerating market listing in Australia. However, the Australian government has begun to deny recognition of certain Notified Bodies. In Japan, if your device qualifies for Pre-Market Certification (most Class II and some Class III devices), conformity assessment will be performed by a private Registered Certification Body. Seven of the fourteen RCBs also provide CE Mark in Europe. In Korea, a similar situation applies to most Class II devices. In Malaysia’s new and evolving regulatory system, all devices must undergo local conformity assessment, though the assessment for devices with reference country approval is greatly expedited. In these cases, manufacturers may request synergies if their Notified Body is also their RCB in Japan or Third Party Reviewer in Malaysia and South Korea.

Budget to Control Your Registration Certificate in Asia
In the US, Europe and Canada, the manufacturer on the labeling is considered the owner of the product registration certificate. In all other regulatory systems, the license/certificate/listing is owned or fully controlled by a local agent. In these markets, foreign manufacturers can only change or add distributors with the cooperation of the incumbent license holder. If the license is held by a commercial distribution partner, it is difficult to add, change or influence distributors in that market. Also, start-up companies with acquisition strategies have added incentive to control registration certificates to enhance acquisition value and enable the acquiring company to integrate new device/s into its direct sales channel. This situation can only be assured through an independent license holder.

Consult with Asia Actual for specific conditions that apply to your devices in Asia.

Medical Device Sales in Asia

29 countries in the Asia Pacific sales region do not have a national medical device regulatory review system.

Asia Pacific Sales Region – Medical Device Registration Systems:
44 countries
3.74B people
$31B device market
29 countries without regulatory review systems
15 countries with regulatory systems
9 countries with reference country approval requirements
Note: hospital purchasing managers in these countries may require products to have home or reference country approval.