Outdated啦！泰国注册不再需要FSC

Many companies in China don’t know that FSC, Free Sales Certificate, is no longer required. Here I gather some information about Thailand FDA registration for your reference.

In 2019, the total market size of medical devices in the country reached approximately 1.8 billion U.S. dollars and is forecast to amount to over 3.3 billion U.S. dollars in 2027. As for imports, the United States was also the major source country for medical devices imported to Thailand. This was followed by China.

With its large pharmaceutical market, nationwide health care access, and foreign-friendly regulatory environment, Thailand presents great opportunities for medical companies looking to enter the Thai markets. In addition, as the country’s population grows older and its dependence on medical imports continues to increase, and Thailand’s domestic medical device manufacturers generally only make basic medical products such as syringes and gloves; thus, the country is dependent on foreign imports for complex or high-end medical devices. This provides significant importation opportunities for Chinese medical device manufacturers.

If you are looking to register your medical device product in Thailand, PureID is here to help. Our regulatory consultants can help you through the Thai registration and licensing processes and secure approval for your medical device in the shortest possible time frame.

The new regulations provide for 4 classes of risk (unlike the previous 3) and they apply to both Medical Devices (DM) and in Vitro Diagnostic Medical Devices (IVD).

Thailand’s medical device registration is managed by the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (FDA). The regulatory process is based on the Medical Device Act B.E. 2551 (2008) and updated by the Medical Device Act/Ordinance B.E. 2562 (2019) (Issue 2). New regulations recently went into effect on February 15, 2021, bringing closer alignment with the ASEAN Medical Device Directive (AMDD).

An import license must be obtained from the Thai FDA before the device can be imported to, or sold in Thailand.Conformity Assessments under the new regulations will require applications for Class 2-4 products be submitted in the Common Submission Dossier Template (CSDT) format while Class 1 Listed products require less documentation. An Establishment License issued by the Thai FDA of the local registrant and license holder is also required.

In Thailand, the product license holder could be the same importer and distributor. PureID can help companies to obtain product license and import products to Thailand.

Application process

1. Applicants must submit the required documents to the Thai FDA service center;

2. The submitted documents are reviewed and recorded by a regulator of the Medical Device Control Division;

3. A staff member records the applicant’s files into a database system, and the applicant is provided with a reference number and receipt;

4. The applicant obtains the letter of approval for importation.

5. The Certificate of Free Sale is no longer required for the registration of medical device in Thai.

Benefits of Using PureID as Your Independent License Holder

· Increase transfer pricing

· Improve leverage in distributor negotiations/responses

· Add or change distributors as required

· Keep intellectual property away from local commercial agents

· Assure expert handling of post market vigilance and license maintenance

注册流程图如下：

使用 PureID 作为您的泰国许可证持有者的好处

• 提高转让定价

• 发挥经销商谈判/响应中的杠杆作用

• 根据需要添加或更改分销商

• 让知识产权远离当地商业代理

• 确保专家处理上市后的警惕性和许可证维

Contact PureID with questions or a request for support in Thailand. PureID has a fully licensed offices in Bangkok staffed by experienced, bi-lingual regulatory and commercial professionals to offer medical device registration, independent license holding, importing and sales support services in Thailand.

如有问题或在泰国寻求支持，请联系下方普瑞纯证官方客服微信。普瑞纯证拥有经验丰富的双语监管和商业专业人员，可为您在泰国提供医疗器械注册、独立许可持有、进口和销售支持等服务。