Considering the complexity of the importing test samples and the risk of test laboratories losing accreditation, it is important for manufacturers seeking medical or diagnostic device registration in Russia work with an experienced, local partner who can make an informed selection of test laboratories and take fast corrective action should the selected lab be affected.
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 Central Drugs Standard Control Organization (CDSCO) 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.
Contact Asia Actual for specific conditions that apply to your devices in Asia.
On the May 31st Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor) published Decree No. 633 which includes provisions that significantly improve the registration process for medical and IVD devices. The changes go into full effect on June 13th, 2018.
Main points from Decree No. 633 impact:
- Combination Device Registrations
Medical devices which contain pharmaceuticals (e.g., bone materials, drug eluting stents, dermal fillers, glues, etc.) can now be registered in Russia if the pharmaceuticals component is registered in its country of origin. Since March of 2017, such devices could only be registered in Russia if the pharmaceutical component was registered in Russia.
- IVD Device Registrations
The requirement to obtain permission from Roszdravnadzor to conduct clinical trials in Russia as part of the registration process has been removed. By eliminating the required permission, the manufacturers may move directly to conducting trails whereby saving 2 to 3 months in the registration process for Class 2a, 2b, 3 IVD devices. The updated procedure now includes Technical File and IFU development to Russian standards, technical and EMC testing (if required), clinical trials arrangement; and application submission to Roszdravnadzor.
- License Amendments
Decree No. 633 clarifies the requirements and procedures to amend current registration certificates. Previously without clear guidance changes to a certificate may have resulted in the need for re-registration. Now changes such as adding/deleting new models, or accessories, changing the Authorized Representative, labeling changes, etc. are available according to the law and in accordance with EAEU guidelines.
The decree amends the Rules of State Registration of Medical Devices № 1416 which were approved by the Government of the Russian Federation on December 27, 2012.
Asia Actual has a strong regulatory team in Moscow to provide efficient, transparent management of device registrations, post market vigilance and Authorized Representative services.
Please contact either of us with questions or service requests.
Asia Actual is excited to announce the extension of regulatory and commercial services to support client operations in Russia.
Medical device manufacturers must appoint, and grant Power-of-Attorney to a local, registered company in Russia to submit registration applications and act as Authorized Representative (AR). The Russia AR will be listed on the local labeling and be responsible for post market vigilance reporting.
Appointing a reliable, professional Authorized Representative is critical to a successful business strategy in Russia.
Please contact us or visit our updated website for more information.