Increased regulatory status of breast implants from Notified to Licensed (Class 4) will increase cost and time required to obtain an Import License.
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 August 20, Hong Kong’s Medical Device Control Office (MDCO) posted information about a pilot program for the expedited review for Class II, III and IV medical device listing applications. Qualified applications will be accepted from this September 1st to June 30th of next year. The expedited review is expected to shorten the target review time to 8 weeks.
In addition to the standard documentation requirements, the Expedited scheme also requires a Device Profile Form (see template here) and Declaration Letter.
To summarize qualifications, products must have:
- no reported deaths or serious injury associated with the device (local and worldwide)
- no active recalls, field safety corrective actions or adverse incidents (local and worldwide)
- two or more valid reference country approvals for at least three years from Australia, Canada, the EU, Japan, or the US (note Australian approval based on the Mutual Recognition with the EU approval will not be counted as a separate approval)
- at least one substantially equivalent device listed in the Hong Kong Medical Device Administrative Control System (MDACS)
Each Local Responsible Person can have 2 expedited applications in process at one time.
Application queries by the MDCO must be closed within 2 weeks of receiving notice. If not, the application may be moved to a standard application review, but will remain against the 2-application quota for the LRP until approved.
Likewise, if the application is withdrawn, the applicant’s quota will be frozen for 1 year from the date the application reached MDCO. So only applications with high confidence of success should be submitted.
Asia Actual has fully licensed office in Hong Kong (including a Radio Dealers License for importing devices that include wireless technology) staffed by high level regulatory professionals. Please contact us with questions about the new program or our regulatory and Local Responsible Person (license holding) services.
Today (February 11, 2019) the Medical Device Control Office (MDCO) opened the voluntary device registration system to Class B and C IVD devices. Previously only Class D (high risk) IVD devices were include under the Medical Device Administrative Control System (MDACS).
A copy of the Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Devices (GN-06E (2019) can be found here.
The regulatory systems for IVD and medical devices is currently voluntary in Hong Kong and now open all but and Class A IVD devices Class I medical devices.
Manufacturers typically participate in the voluntary system to (1) gain a sales advantage as the Hospital Authority requires or gives preference to registered devices in public hospital purchasing decisions and (2) avoid confusion and delays that will come when the system becomes mandatory. To date more than 5,000 devices have been registered by the MDCO under the voluntary system.
Asia Actual has a office in Hong Kong staffed by experienced regulatory professionals. Please contact us with questions or support
Legislation for the creation of mandatory medical device regulations was introduced into the current legislative session in Hong Kong. Regulations and requirements are expected to be very similar to those under the current voluntary system. If passed into law before the close of session in July, implementation is expected in the beginning of 2018.
Because the voluntary Medical Device Administrative Control System (MDACS) has been in place since 2004, the Department of Health is not expected to provide for a transition period. Devices that are not registered by the implementation date will loose access to the Hong Kong market. Manufacturers are encouraged to participate in the voluntary system to avoid any potential loss of market access.
Contact Asia Actual with any questions or support needs.
A large number of medical device listings in Hong Kong are coming to the end of their 5-year validity period and must undergo a re-registration process in order to maintain an active Medical Device Listing.
The Hong Kong Medical Device Control Office (MDCO) is reminding industry that re-registration applications must be submitted at least three months prior to the expiry data to ensure continuous listing. Medical and IVD devices that are within 3 months of their listing validity date, or that have had a major change, must submit a new registration application. This could add significantly to the documentation requirements in support of the application. Individual reminders will not be issued by the MDCO, so manufacturers are advised to confirm with their Local Responsible Person about their specific deadlines and action plans.
While medical device registration is currently voluntary in Hong Kong, public hospital tenders will advantage or require listed medical devices. There are around 4,175 active medical devices listed in Hong Kong as of June 1, 2016.
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:
$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.