Increased regulatory status of breast implants from Notified to Licensed (Class 4) will increase cost and time required to obtain an Import License.
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Likewise, if the application is withdrawn, the applicant’s quota will be frozen for 1 year from the date the application reached MDCO.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