How the EU MDR’s Changes Will Affect Licenses in Asia

While each Asian market has their own regulatory nuances, most ASEAN member countries have harmonized with the Medical Device Directive (ASEAN MDD) and will have similar requirements. For the most part, each market will have 2 levels of amendments, typically referred to as “notification” or a “change.” A notification is used for administrative updates while a change, like a Technical Change in Singapore, is usually required for more technical requirements, such as expansions to the indications for use. Since most of the applicable EU MDR-related changes will affect labeling and IFU, the changes can usually be addressed through a notification amendment in the local markets.

Some of the common items that may cause manufacturers to adjust their labeling or documentation include the following items:

1. CE Number may be different
2. Changing the “Intended use” to “Intended Purpose” per MDR definition.
3. Additions of new symbols (according to ISO 15223-1:2021 and generally recognized symbols).
4. Clinical Benefit section to the IFU
5. Additional performance characteristics per MDR requirements
6. Additional assembly information (if applicable)
7. Devices shipped to the UK after June 2023 will need to carry a UKCA marking

Manufacturers with existing stock with old labeling can still import with the old labeling but will need to amend their license(s) before importing product with the new labeling and/or IFU.

India Amendment Process

In India, there are two types of amendments available, a Minor or a Major Post Approval Change (PAC). Any change to the product’s labeling or IFU other than changes to its design, color, or layout is considered a Major change. Major PACs, as well as Minor PACs, require approval prior to importation. More than 1 change to the label and/or IFU can be submitted under one application but separate applications will be needed for each product on the Import License. Most Post Approval Changes don’t require review fees but since it’s up to the reviewers, government fees are sometimes required.

For example, a significant change in the intended purpose of an already approved device may trigger the requirement of re-registration with a review fee. Post Approval Changes are typically approved in 3-6 months. With changes in the CE mark, the Indian regulator may check the current Free Sales status in an EU nation (Free Sales Certificate), if the current approval is based on an EU reference.

Changes That Require a Major Post Approval Change

Changes in respect to the following are considered a major change in India:

1. material of construction;
2. design which shall affect quality in respect of its specifications, indication for use; performance and stability of the medical device;
3. the intended use or indication for use;
4. the method of sterilization;
5. the approved Shelf life;
6. the name or address of
   1. the domestic manufacturer or its manufacturing site;
   2. overseas manufacturer or its manufacturing site (for import only);
   3. authorised agent (for import only);
7. label excluding change in font size, font type, colour, label design;
8. manufacturing process, equipment or testing which shall affect quality of the device;
9. primary packaging material.

Thailand Amendment Process

Changes to the labeling or IFU will require a Minor Change in Thailand. Manufacturers are able to submit under the minor change route to update the labeling or IFU as long as it doesn’t affect the efficiency or safety of the medical device such as changing colors, adding/cancelling/changing formats, images, symbols, barcodes or altering text without affecting its overall meaning. Additionally, manufacturers can update the labeling or IFU to improve the safety of the medical device such as adding warnings or precautions. The latest amendment guidance, released in March 2022, is found here.

This process is relatively quick and can be completed in less than a month and costs about US$15 with an additional US$680-850 if a Specialist Review if required.

Minor Changes Permitted in Thailand

Minor changes are available in Thailand, cost about US$15, and are typically approved in one month.

Permitted Minor changes:

1. Increase/decrease/change sterilization facilities where the sterilization
   process has not changed
2. Add or remove the list of medical devices in the same medical device group
   without changing in a grouping category
3. Change physical manufacturer, but legal manufacturer/product owner remains
   the same.
4. Name or address of the product owner without changing a physical
   manufacturer
5. Name of physical manufacturer without changing the location
6. Decrease shelf life or increase the degree of strictness of storage.
7. Update Label or IFU without affecting the efficiency or safety of the medical device
8. Update Label or IFU, to improve safety of medical devices like warnings or precautions
9. Update Product codes, still the same medical device.
10. Software updates that does not affect efficiency and safety of medical device.

Indonesia Amendment Process

Indonesia’s MOH will also require an amendment, locally known as a Variation, to the license for changes to the labeling and IFU. This process is completed within 1o days and requires a fee of US$75. One amendment per license will be required. Indonesia’s Decree of Ministry of Health No. 62 /2017; article no. 30 provides for amending an existing product license to account for changes to packaging dimension, packaging size, labeling (includes IFU), and/or the local license holder’s address. All other product changes would require a new registration submission.

Variations Permitted in Indonesia

Manufacturers can submit a Variation application to an existing product license is any of the following are updated:

1. size;
2. packaging;
3. labelling;
4. accessories/annex of the product license; and/or
5. name and/or address of representative authorized by Manufacturer.

Any other change will require a new license.