Official transition from policy-based classification to risk-based classification for Class 1 medical device started from March 17, 2021, onwards. There are a total of three announcements primarily focusing on Listing (Class 1) Medical Device with content as follow:
- The exemption of Technical documents during the grace period of Listing Medical Device.
Please refer to the table below for your reference:
|
No. |
Document lists |
Listing MD Partial Route* |
|
1 |
Device description e.g. Device description and features |
√ |
|
2 |
Product specification |
√ |
|
3 |
Device labeling |
√ |
|
4 |
Certificate or a letter indicating commercial marketing history |
х |
|
5 |
Sterilization test report if medical devices are sterile products |
х |
|
6 |
Calibration test report if medical devices are measurement products (Metrological requirements) |
х |
|
7 |
Declaration of Conformity |
х |
|
8 |
Letter of Authorization for Authorized representative |
√ |
|
9 |
Declaration letter of grouping medical devices registration |
If any |
*Remark: Partial Route: Applicable for Import Permit with less than 1-year validity from March 17, 2021, onward.
2. Listing Medical Device License Renewal. The list of requirements is as follows:
(a) Establishment Importer License No. or Establishment Manufacturer License No.
(b) Listing License No.
(c) Name and Address of Manufacturer or Importer
(d) Letter of Authorization for Authorized Representatives and copy of Company Certificate in case of an authorized representative
Registrant shall proceed with document compliance within the timeframe otherwise the application will be rejected. Authority will issue the new License upon approval. In case of rejected application, the authority will inform the applicant stating the justification. The applicant shall appeal within 15 days of the rejection date.
3. Listing Medical Device Change Notification. Applicable changes are as follows:
(a) Manufacturer name and address (location is not applicable for change notification)
(b) Legal owner name
(c) Legal owner name and address
(d) Declaration of conformity from the manufacturer or legal owner
(e) The information demonstrates in device labeling or packaging insert (intended use and indication is not applicable for change notification)
(f) Medical device grouping
Other amendments apart from the above shall be subject to the authorized committee’s consideration. Approval of change will come in the form of an annex of license or a letter to the applicant. Change notification procedures shall be submitted electronically.
References:
Food and Drug Administration Announce the Change Notification of Listing Medical Device Registration