AUTHORIZED REPRESENTATIVE (MEDICAL DEVICES - THAI)

REGULATING MEDICAL DEVICES

To place medical devices on the market in Thailand, non-local companies must comply with regulatory requirements set by the Thai Food and Drug Administration (FDA).

Each organisation wishing to import medical devices into Thailand must have an authorized representative available. The role of the authorized representative is essential in this process.

The regulations are governed under Medical Devices Act, B.E.2551 (2008) and (No. 2), B.E. 2562 (2019).

Medical devices will be required to undergo one of three registration routes to acquire an Import License depending on their classification. Class 1 products will require a Listing, Class 2 and 3 will require a Notification and Class 4 (highest risk) will require a License.

COUNTRY AUTHORIZED REPRESENTATIVE RESPONSIBILITIES

Non-local companies are required to appoint a local authorized representative in Thailand.

In order to sell into Thailand, the Thai FDA require a local registrant and license holder.

These will be issued with an import license, who will take ownership and control of the license.

The authorized representative acts as a liaison between the non-local company and the Thai FDA.

The authorized representative may also be held responsible for ensuring compliance with Thai regulations.

Here is a summarized overview of the key compliance requirements with an emphasis on the role of the authorized representative:

1. Product Registration:

• Non-local companies must register their medical devices with the Thai FDA before they can be legally marketed and sold in Thailand.
• Registration involves submitting detailed documentation about the device's safety, quality, and efficacy.

2. Authorized Representative:

3. Quality Management System (QMS):

• Medical device companies must establish and maintain a QMS compliant with international standards, such as ISO 13485.
• The Thai FDA may inspect and audit the QMS to ensure compliance.

4. Labeling and Packaging:

• Medical device labeling and packaging must comply with Thai regulations, including language requirements.
• The authorized representative may assist in ensuring proper labeling and packaging.

5. Clinical Data and Testing:

• Depending on the risk classification of the device, clinical data and testing may be required to demonstrate safety and efficacy.
• Non-local companies must provide this data as part of the registration process.

6. Post-Market Surveillance:

• Companies must have a system for monitoring and reporting adverse events or product defects to the Thai FDA.
• The authorized representative may help with reporting obligations.

7. Fees and Payments:

• Non-local companies are typically required to pay registration fees and annual renewal fees.
• The authorized representative can assist in handling these financial transactions.

8. Compliance with Thai Laws:

• Non-local companies must adhere to all Thai laws and regulations related to medical devices.
• The authorized representative plays a role in ensuring ongoing compliance.

9. Notification of Changes:

• Any changes to the medical device or its manufacturing process must be promptly reported to the Thai FDA through the authorized representative.

10. Periodic Inspections:

• The Thai FDA may conduct periodic inspections of the manufacturing facilities, storage facilities, and records of non-local companies through the authorized representative.

In summary, non-local companies looking to place medical devices on the market in Thailand must adhere to a range of regulatory compliance requirements, with the authorized representative serving as a crucial link between the company and Thai authorities. The authorized representative assists

In various aspects of compliance, including registration, communication with the Thai FDA, and ongoing regulatory responsibilities. It's essential for non-local companies to work closely with their authorized representative to navigate the complex regulatory landscape in Thailand effectively.