Change Notification guidance incorporate all 4 classes of medical devices in Thailand.

Change types that are applicable for Thai FDA;

  1. 1. Change Notification for Listing:
       Turnaround time shall be subject to the auto approval

Change Notification Scope

Required Documents

Change in manufacturing/product owner/grouping details

1) Name and address of the manufacturers in case that there is no change in the site location.

• Labelling and IFU

• Declaration Letter indicating that the manufacturer's location in another country has not changed from the product owner

• DoC

2) Name of Product owner

(In case of merger).

• DoC

• LoA

•Declaration Letter from the product owner indicating that there is no change to the manufacturer.

3) Name and address of product owner

(Physical manufacturer shall remain).

• DoC

• LoA

• Declaration Letter from the product owner indicating that there is no change to the manufacturer.

4) DoC from Product Owner or physical manufacturer.

• DoC

5) Labelling or IFU amendment that do not affect device intended and indication.

• Labelling and IFU

• Declaration Letter from the product owner clarifying labelling and IFU amendment.

6) Medical device grouping (e.g., additional color, size, add or remove medical device list in the same group)

(The change shall not affect the existing grouping).

• Labelling and IFU

• DoC

• LoA

Change in product details

1) Amendment of shelf-life or raise severity level of storage.

• Design Verification and Validation

• Risk Analysis

2) Labelling or IFU amendment (The change shall not affect medical device efficiency or safety.) e.g., change of color, picture, sign, barcode, or message that in conclusion will not affect the overall meaning.

• Labelling and IFU, highlighting the amendment, along with the recent update Labelling and IFU.

• Declaration Letter indicating that the amendment does not affect medical device efficiency or safety

3) Labelling or IFU amendment of safety escalation

e.g., amendment of warnings, cautions, contraindications and/or adverse effect.

•Labelling and IFU, highlighting the amendment, along with the recent update Labelling and IFU.

•Declaration Letter indicating that the amendment does not affect medical device efficiency or safety

• Risk Analysis

4) Product code amendment

e.g. product code amendment for post market surveillance control.

• Declaration letter comparing the original and new (amended) medical device code from the product owner.

•Labelling and IFU, highlighting the amendment, along with the recent update Labelling and IFU.

• DoC

• LoA

• Declaration Letter from the product owner indicating that there is no amendment on the medical device appearance, shape, intended use, technical specifications and/or sterilization process

5) Product list or accessory table due to typo.

Declaration Letter of incorrect input of data or accessories from importer

  1. 2. Change notification for Notified Medical Device and Licensed Medical Device:
    • Major Change: Turnaround time 35 working days
    • Minor Change: Turnaround time 5 working days

Change Notification Scope

Required Documents

Major change

1) Add indication/intended use

1.1 Request to amend an approved indication or adding new indications, such as change in design characteristics, product specifications.

• Evidence of approval to add or amend product indications by a foreign medical device agency

• Labelling and IFU, highlighting the amendment, along with the recent update Labelling and IFU.

• DoC

• Design Verification and Validation

• Clinical Evidence

• Risk Analysis

1.2 Request to amend an approved indication or adding new indications due to software amendments (for active medical device) affecting the main operational control mechanism, the sterilization process of primary packaging, and or amendment in the design of the medical device.

• Evidence of approval to add or amend product indications by a foreign medical device agency

• Labelling and IFU, highlighting the amendment, along with the recent update Labelling and IFU.

Device verification and validation (e.g., Summary of software changes, Overview of all verification, validation, and testing, Summary all unresolved variances in the release version of the software, Evidence to demonstrate that the software issue has been resolved)

• Clinical Evidence

• Risk Analysis

2) Adjust the principal ingredients or components that do not affect product specification

2.1 Amendment in the type, origin, production process of biological materials (including cells, tissues and/or derivatives of animal, human, microbial or recombinant origin) without changing the purpose of use of the biological materials.

Device verification and validation

• Biological Safety Data

• Information of Sources/Donors

• List of material(s) making direct/indirect contact with the human body

2.2 Amendment in raw materials for medical device manufacturing or Raw materials supplier amendment for medical device manufacturing.

Device verification and validation

• List of material(s) making direct/indirect contact with the human body

3) Product specification

Device verification and validation

(e.g., Physical Test)

• Risk Analysis

• Labelling and IFU, highlighting the amendment, along with the recent update Labelling and IFU.

• Product Specification

4) Amendment of shelf-life or raise severity level of storage.

Device verification and validation

(e.g., Stability Test)

• Risk Analysis

5) Primary packages which affect the quality of medical devices or Sterile primary packaging.

Device verification and validation

(e.g., Stability Test)

• Risk Analysis

•Labelling and IFU, highlighting the amendment, along with the recent update Labelling and IFU.

6) Manufacturing process that affects product efficiency and safety

6.1 Amendment in manufacturing process leading to an amendment of the product specification.

• Summary of new manufacturing process

Device verification and validation

• Product Specification

6.2 Amendment in the sterilization method

• ISO 13485 or medical device GMP of  the manufacturer

• Labelling and IFU with highlighting the amendment, and the most recent updated Labelling and IFU

• Sterilization Validation Report including EO Residuals Report (if any) and Evidence of continuous sterilization validation

Device verification and validation

 (e.g., post-sterilization functional, biocompatibility)

Minor Change

1) Add/reduce/amend the sterilization facilities that there is no change in the sterilization process.

• Declaration Letter from the product owner indicating that there is no amendment in the medical device appearance, shape, intended use, technical specifications and/or sterilization process

2) Add/reduce product list in the same grouping that shall not affect the existing grouping.

• Labelling and IFU

• DoC

• LoA

3) Physical manufacturer amendment

(no amendment in the legal manufacturer/ product owner).

• Declaration Letter from the product owner indicating that there is no amendment in the medical device appearance, shape, intended use, technical specifications and/or sterilization process

• DoC

• ISO 13485 or medical device GMP of the amended manufacturing site.

• Labelling and IFU with highlighting the amendment, and the most recent updated Labelling and IFU

4) Name and address of the product owner amendment

(No amendment in physical manufacturer).

• DoC

• LoA

• Declaration Letter from the product owner indicating that there is no amendment in the manufacturer's location

5) Name of the physical manufacturing amendment (no change in site location).

• Labelling and IFU

• Declaration of Conformity

• Declaration letter from product owner indicating that there is no amendment to the manufacturing site.

• A letter from a government agency or agency in that country indicating amendment in the name of the owner or product without amendment in the manufacturing site location

• In case of merger, please provide a merger contract

6) Amendment of shelf-life or raise severity level of storage.

Device verification and validation

• Risk Analysis

7) Labelling or IFU

(The amendment shall not affect the medical device’s efficiency or safety).

• Labelling and IFU with highlighting the amendment, and the most recent updated Labelling and IFU

• Details + pictures showing the packaging (in case of change in packaging size)

• Declaration Letter indicating that the labelling and the IFU amendment will not affect the medical device’s efficiency or safety

8) Labelling or IFU

(Amendment in safety escalation)

• Labelling and IFU with highlighting the amendment, and the most recent updated Labelling and IFU

• Risk Analysis

• Declaration Letter indicating that the labelling and the IFU amendment will not affect the medical device’s efficiency or safety

9) Product code

• Declaration letter comparing the original and the new (amended) medical device code from the product owner

• Labelling and IFU with highlighting the amendment, and the most recent updated Labelling and IFU

• DoC

• LoA

• Declaration Letter from the product owner indicating that there is no amendment in the medical device appearance, shape, intended use, technical specifications and/or sterilization process

10) Software amendment

(The amendment shall not affect the medical device’s efficiency or safety).

Proof of approval of the amendment from the product licensing authority

• Labelling and IFU with highlighting the amendment, and the most recent updated Labelling and IFU

Device verification and validation (e.g., Summary of the software changes, Overview of all verification, validation, and testing, Summary of all unresolved anomalies in the release version of the software, Evidence to demonstrate that the software issue has been resolved)

 

 

References:
Thailand FDA - Guidance on Change Notification for Medical Device 1 March 2022

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