Overview of the Regulations and Guidance related to GDP in Taiwan
According to Medical Devices Act, article 24, in May 2020, , Taiwan FDA has launched the draft "Regulations of Medical Device Good Distribution Practice" which are promulgated pursuant to the Paragraph 3 of Article 24 of the Medical Devices Act.
In this article we list important compliance requirements of this upcoming regulation for medical devices below.
(1) Documentation standards
Documentation is required to include all written procedures, instructions, contracts, records, and data, in paper or in electronic form and must be able to track relevant operations during the distribution of medical devices. The documentation should also be readily available and should be made at each time of the distribution.
(2) Organization and Personnel Standards
Distributors must designate personnel responsible for GDP compliance. The relevant personnel of distribution activities should have appropriate competence and experience as well as knowledge and training in GDP regulations.
(3) Transportation Standards
The storage requirements for medical devices should be maintained during transportation within the defined limits as instructed on the relevant packaging information. Containers and packaging methods should be selected based on the storage and transportation requirements for each product.
(4) Premises and equipment standards
Distributors must have suitable and adequate premises, installations and equipment, so as to ensure proper storage and distribution of medical devices. All of the equipment affecting on storage and distribution of products should be designed, located, maintained, and cleaned to a standard which suit theirs intended purposes. Equipment and processes should be respectively qualified and validated before commencing the use and after any significant changes.
(5) Outsourced activities standards
Any activity covered by the GDP regulations that is outsourced should be correctly defined, agreed and controlled in order to avoid misunderstandings which could affect the integrity of the product. There must be a written contract between the distributor and contractor which clearly establishes the rights, obligations, and duties of each party.
(6) Complaints, returns, and recalls standards
All complaints, returns, and recalls must be recorded and handled carefully according to written procedures. An assessment of returned products should be performed by designated personnel before any approval for resale.
(7) Self-inspection standards
Self-inspections should be conducted in order to monitor implementation and compliance with the principle of GDP regulations and to propose necessary corrective measures.
(8) Corrective and prevention standards
Distributors should document the procedures to eliminate the cause of nonconformities.
Implementation Status of GDP and Transition Period
In May 2020, TFDA has launched draft guidance about GDP as well as defined high-risk categories of medical devices which will be inspected in the first stage. This draft will become effective in 2021. Domestic manufacturers and distributors who hold medical device dealer permits are required to apply for the inspection of Taiwan’s GDP and obtain the distribution license. The enforcement of the GDP is said to start two years later since its implementation.
How the Stakeholders (MFR, License Holder, Distributor) shall pay attention to
Distributors and License Holder should well-prepare GDP-related SOP and records to control throughout the distribution chain in Taiwan within 2 years. The documents including any business activities dealing with importing, wholesale, distribution and service must meet the GDP guideline and followed by stakeholders.
According to on-site inspection by TFDA/ITRI, how does TFDA regulate each stakeholders’ responsibilities?
Distributors and License Holder should submit relevant documents for conforming assessment, and TFDA/ITRI will take onsite inspection to ensure medical devices that are consistently stored, transported, handled under the suitable manners and conditions as required.
The companies are required to establish quality manuals and related SOP and keep related records throughout the entire distribution chain. The outsourced service providers also fall within the scope of this GDP guideline. Each stakeholder should establish the contracts to define their rights, duties and obligations.
In 2019, Qualtech has participated in a test run audit for Taiwan’s GDP and received an award from the TFDA for its performance. Qualtech can assist you with the GDP establishment and implementation in your company by utilizing our successfully audited experience with TFDA. Feel free to contact us for more detailed information.