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Southeast Product Certification

Southeast Product Certification


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Thailand medical device registration
Southeast Asia product certification introduction



태국 의료기기 등록-국기



Licensing procedure


In order to handle imported medical devices in Thailand, business registration, medical device import license (Thai FDA), and certification procedures according to the classification of medical devices are required.


Licensing procedure

    The conformity assessment of medical devices is regulated by the Medical Device Act 2008 and is under the jurisdiction of the Food and Drug Administration (FDA) under the Ministry of Public Health.

    Regarding product certification, the Thai Food and Drug Administration categorizes medical devices into three categories: General Medical Device, Notified Medical Device, and Licensed Medical Device. Is 5 years, and an extension is required after 5 years.

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1. General Medical Devices Certification_Class l

    Producers, importers, or distributors of products in this category do not need to obtain a separate license. However, they are required to submit a Certificate of Free Sale issued by the government of the country of origin. As an exception, for the following medical devices that are used directly on the human body among general medical devices, ISO 13485 or GMP certificates must be submitted.

    ✡ Implant

    ✡ Tissue origin medical device

    ✡ Radiation equipment for diagnosis and treatment In vitro diagnostic equipment (In Vitro Diagnostic Products)

    ✡ Medical equipment disinfection supplies

    ✡ Tooth filling, prosthetic-related devices

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2. Notified Medical Devices Certification_Class ll

    In addition to the certificate of free sale issued by the government of the country in which the product is produced, producers, importers or distributors of products falling under this category must submit product technical documentation together with a declaration form (Jor Nor 1), which must include:

      ✪ Product technical documentation: product instructions, instructions, specifications, labels, names of producers and distributors

      ✪ Target medical device

      Rehabilitation treatment medical equipment

      Blood alcohol diagnostic tool

      Medical silicone

      Other diagnostic tools

      Silicone breast implants

      Ophthalmic Viscosurgical Devices; OVD

      Metamphetamine screening test in urine

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3. Licensed Medical Device Class III

    Producers, importers, or distributors of products falling under this category must obtain a license to produce, import and sell products. The Thai Food and Drug Administration requires the licensee to submit information on the production process, import, sale, and side effects of the product. Also, the Thai Food and Drug Administration requires a Certificate of Free Sale and an application for permission (Khor Por 1) issued by the government of the product producing country. ) Must be submitted.

      There are 8 types of medical devices in this category:

      HIV diagnostic tool

      condom

      Lab gloves

      surgical gloves

      Medical blood bag

      Contact lens

      Disposable hypodermic syringe

      Disposable insulin syringe


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Related Services from IGC

  • 01System Certification (ISO 13485, ISO 15378, ISO 14155)

  • 02Product certification (European CE certification, clinical evaluation, medical device registration [Eurasia, China, USA, Thailand, Taiwan])

  • 03Certification of screening qualifications

  • 04Professional manpower training education

Taiwan medical device registration
Taiwan product certification introduction

Medical devices exported to Taiwan must be licensed and registered in accordance with the registration requirements required by TFDA (Taiwan Food and Drug Administration). Since February 2004, Taiwan has compulsory requirements for medical device GMP for medical devices sold in Taiwan, and this certification was established based on the contents of ISO 13485.

The medical device market in Taiwan is showing continuous growth as awareness of the need for medical system development spreads, and the market growth will be further promoted by the advancement of the health care system and the government's support for the medical device industry.



Medical device definition and classification

    According to the Pharmaceuticals Affair Law of Taiwan, medical devices include equipment, machinery, instruments and accessories, and are defined as products that can affect diagnosis, treatment, healing, disease alleviation, disease prevention, or body function or structure.

    The classification of medical devices in Taiwan basically follows the classification of the US FDA. It is largely divided into general medical devices and in vitro diagnostic medical devices, and is classified into 17 categories according to the function, purpose, use and operating principle of the product. It is classified into three classes (Class I, II, III) according to the characteristics and risk of medical devices.

      Class I (Low risk)
      A medical device that does not sustain or prolong life, is not used for a very important purpose in preventing human damage, and does not have the potential for risk of disease or injury.

      Class II (Medium risk)
      Medical devices recognized as being used to sustain or extend life.

      Class III (High risk)
      A device that sustains or prolongs life, or a device that is of great importance to prevent human damage, or that may present a potential risk of illness and injury.

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Registration process

    The procedure for registration of medical devices in Taiwan is as follows.

      1. Classification of medical devices
      ✧The Taiwan medical device registration process is essential for all classes of medical devices, and the documents to be submitted differ depending on the class of medical devices. Therefore, the product must be properly classified prior to application.

      2. Designated as a local representative in Taiwan
      ✧For overseas manufacturers who wish to sell medical devices in Taiwan, they must appoint a local representative in Taiwan. The Taiwan agent must reside in Taiwan and have a sales license in Taiwan. Agents register medical devices on behalf of the business, contact TFDA directly, and conduct business.

      3. Product Permit/Report Application
      ✧ Application for a product license varies depending on the medical device class.

      4. QSD (GMP) preparation and application
      ✧For local manufacturers in Taiwan, certification must be obtained according to the procedure for obtaining GMP for medical devices, and for overseas manufacturers, if they have ISO 13485 certificates, they must undergo a QSD (Quality System Documentation) review.

      5. TFDA audit
      ✧Prepare a quality system certification document and submit it to the agency designated by TFDA, and the audit agency will conduct the review. Overseas manufacturing site audits are conducted as needed.

      6. Issuance of final certification
      ✧After registration of medical devices with TFDA is completed, products can be distributed in Taiwan.


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Required information and documents

    The Taiwan medical device approval process consists of product license/report application and quality system certification.

    1. The documents to be prepared by the medical device manufacturer when applying for product approval/declaration differ by medical device class.

      1) Class I
      ✻ Application
      ✻ Copy of medical device manufacturing business license
      ✻ For Taiwanese local manufacturers, GMP conformity certificate
      ✻ For overseas manufacturers, QSD conformity certificate

      2) Class II / III
      ✻ Application
      ✻ Copy of medical device manufacturing business license
      ✻ For Taiwanese local manufacturers, GMP conformity certificate
      ✻ In the case of overseas manufacturers, the original QSD certificate of conformity and approval for manufacturing and marketing in the relevant country
      ✻ Chinese instruction leaflet, catalog packaging, labeling, usage, product appearance photo
      ✻ Test records and reports
      ✻ Technical documentation
      ✻ Papers and data
      ✻ Clinical trial report
      ✻ In the case of radiation products, safety information data

    2. When applying for medical device quality system certification, Taiwanese local manufacturers must acquire the certification according to the medical device GMP acquisition procedure, and in the case of overseas manufacturers, if they have ISO 13485 certification, the audit is conducted through the Quality System Documentation (QSD). QSD is classified into three categories:

      1)European CE certified manufacturers and US FDA registered products: Subject to QSD simplification
      ✻ Application
      ✻ manufacturer documentation
      ✻ For CE certified manufacturers, a copy of the ISO 13485 certificate, the most recent audit report, CFG (Certificate to Foreign Government)
      ✻ For manufacturers of FDA-registered products in the U.S., factory investigation report issued by FDA, certificate of conformity verification registration, and CFG of FDA manufacturing and sales certificate

      2)Medical device licensed products from other foreign countries: General QSD target
      ✻ Application
      ✻ manufacturer documentation
      ✻ Factory layout
      ✻ Process area for the product
      ✻ List of major production facilities
      ✻ Process process
      ✻ Manufacturing factory quality manual and procedure
      ✻ List of quality documents

      3)If the above does not apply: Subject to field inspection by overseas manufacturers

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IGC’s Competency

    ❅ IGC is contributing to the continuous development of customers by accurately evaluating the suitability of the medical device product quality management system through the technology and expertise accumulated over the years.

    ❅ IGC has up-to-date knowledge of a wide range of specific scopes and legal requirements to assist customers with medical device certification in major markets around the world.

    ❅ IGC provides a variety of certification-related services in the medical device field by establishing cooperative relationships with overseas product certification organizations.

    ❅ IGC provides a variety of certification-related services in the medical device field by establishing cooperative relationships with overseas product certification organizations.


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Related Services from IGC

  • 01System Certification (ISO 13485, ISO 15378, ISO 14155)

  • 02Product certification (European CE certification, clinical evaluation, medical device registration [Eurasia, China, USA, Thailand, Taiwan])

  • 03Certification of screening qualifications

  • 04Professional manpower training education