Taiwan

Medical Devices

In Taiwan Medical Devices are regulated by the Taiwan Food and Drug Administration (TFDA), Taiwan’s equivalent of the United States FDA. The TFDA rests under the authority of The Ministry of Health and Welfare (MOHW) who performs on-site inspection for local manufacturers and reviews Quality System Documentation (QSD) provided by foreign manufacturers. All imported medical devices must obtain a registration certificate from the TFDA. The regulatory process for new medical devices in Taiwan is often complicated and unclear. Most of Taiwanese regulations are in the Mandarin Chinese language and are constantly being changed by the TFDA health authorities.

 

Global Regulatory Partners Inc. (GRP) has a global presence with a team of local experts and affiliated partners in Taiwan who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your device in Taiwan’s market.

For more information of TFDA check website: http://www.fda.gov.tw/EN/

Authorized local agent

Medical companies without presence in Taiwan, should have a local agent that can register their products, maintain their product registrations, get the QDS approved, report all adverse events, and coordinate recalls on their behalf. Global Regulatory Partners, Inc. (GRP) can act as your local agent and provides the following medical device services:

 

GRP Medical Device Services in Taiwan:

  • Communication with the TFDA
  • Assistance with TFDA inspections
  • Adverse Effect Reporting
  • Importation of products
  • Organize and support TFDA consultation meetings
  • Product registration
  • Clinical Trial management
  • Support importation process
  • Post-market vigilance
  • Manage Distributors

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.

At Global Regulatory Partners Inc. (GRP), our team of professionals can provide you with tailored Regulatory Intelligence that includes the latest TFDA regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in Taiwan.

Regulatory Strategy

The regulatory process from product’s design to market entry for new medical devices is often complicated and unclear. Most of Taiwanese regulations are in Taiwanese language and are changing constantly.

Developing the right regulatory strategy is crucial for successful medical device registration in Taiwan. GRP regulatory team stays current with the latest medical devices’ legislation, regulatory requirements and industry initiatives, and always makes sure to communicate these changes to its clients. While developing regulatory strategies, GRP regulatory team takes into consideration the changes in the regulatory landscape.

GRP Medical Device Regulatory Strategy Services in Taiwan:

  • TFDA Regulatory Background
  • Product Assessment based on TFDA Requirements
  • Device Classification based on TFDA rules
  • Authorized Representation requirements for Taiwan
  • Medical Device Registration Requirements
  • Labeling Requirements
  • Costs and Timeframes
  • Regulatory Roadmap for Taiwan
  • Post-market Surveillance Requirements

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development and registration till commercialization. GRP regulatory affairs services in Taiwan include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product’s registration, products’ life cycle management and maintenance.

Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in Taiwan in order to successfully register and commercialize their products in Taiwan’s market and maximize the value of their assets.

Product registration

Device Class Risk Level
Class I Low risk
Class II Moderate risk
Class III High risk
New Medical Device (PMA) If there are no similar devices previously approved by the TFDA, your device will be considered a PMA device. This is the case even if your product has a Substantially Equivalent (SE) device approved by the U.S. FDA.

Pre-Market Approval Process in Taiwan

Determine medical device classification
Class I Class II Class III
Appoint Taiwan Agent
Must have a legal entity established in Taiwan, certified with a Pharmaceutical Sales License)

Prepare QSD application (manual an manufacturing application), ISO 13485 certificate, and QSD certtificate. Submit QSD application for approval. (Certain non-sterile Class I devices are exempt from QSD registration).

Submit QSD application for review by TFDA

Obtain QSD approval letter
*When approved – QSD approval letter will be valid for 3 years
Class II and III
Obtain a Certificate of Free Sale (CFS) or Certificate of Foreign Government (CFG)
Class II and III
Prepare registration application and dossier to the TFDA.
Class I
Prepare registration application for submission to TFDA. Documents include: product information such as labeling and IFU and QSD Approval Letter (if required).

Pay Application Fee

Receive TFDA approval

Appoint Licensed Distributor

Taiwan Agent Files and authorization application for importation of products

Distributor receives TFDA approval letter

Begin marketing of device in Taiwan

Medical writing

Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products in Taiwan. As Regulatory authorities, the TFDA, expect precise, clear and well-written documents, any bad writing or translation can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.

Health authority consultation

It is highly recommended to have a pre-consultation meeting with health authorities such as with the Taiwan Food and Drug Administration (TFDA), during the development of new pharmaceutical or biologic products. Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.

Global Regulatory Partners Inc., (GRP) regulatory affairs team has the expertise in preparing consultation meeting with the TFDA before starting key milestone of your product development.

GRP regulatory affairs team supports includes: writing, preparation and submission of the meeting package to the TFDA health authority, prepare the questions based on the status of your product’s development and future, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting. 

Clinical

Clinical data is required for all PMA devices and Class III IVD and DOH designated medical devices. Foreign clinical data from Western countries are generally acceptable.

Device Class Clinical Trial Requirement Description
Class I Not required Class I medical devices no longer need to be registered with the TFDA; instead, a notification must be filed with the relevant local level Chinese TFDA. However, for the notification application, more documents will be required than there were for Class I registration.
Class II and Class III Devices Required • Mandarin Chinese Specification Drafting (Dossier Preparation and Specification Drafting): 1 month
• Sample Testing: 6 Months
• Filing to the CFDA- Preliminary review and acceptance notice: 1 Month
• CMDE Review- Supplementary notice: 60-90 Business days (2-3 months)
• Supplementary Dossier preparation: 1 year
• CMDE Review: 60 Business days (2 months)
• TFDA Final review- Registration approval: 30 Business days (1 month)

Exceptions For clinical trials:

  • The product has a clear working mechanism, finalized design, and mature production technology. A medical device of the same variety is already on the market and has been used in clinical practice for many years without any record of serious adverse events. There will also not be any changes to the product’s conventional usage.
  • The safety and efficacy of the product can be proven through non-clinical evaluations.
  • The safety and efficacy of the product can be proven through the analysis and evaluation of data obtained from clinical trials or clinical application of other medical devices of the same variety.

An understanding of the regulatory requirements in Taiwan and experience in dealing with the local regulatory authorities (TFDA) is essential in administering a smooth, successful clinical trial in Taiwan. Global Regulatory Partners, Inc. (GRP) can act as your contract research organization (CRO) or help you identify a qualified CROs in Taiwan. Our local teams and affiliated partners located in Taiwan and all-around Asia are highly experienced with the related regulatory affairs and can locally manage the full clinical trial process to ensure that it is conducted effectively and successfully.

GRP’s clinical trials services for medical devices companies in Taiwan:

  • Clinical Trial Consulting Services
    GRP will provide clinical trial consulting services, including consultations with all local government. We can help you develop an effective Clinical Investigation Plan with clinical trial strategy, clinical trial study design, and clinical trial protocol.
  • Regulatory Support
    We can assist with clinical trial applications (CTA) and clinical trial notifications (CTN) as required for clinical trial initiation in Taiwan. Our on-the-ground teams consist of experienced professionals who will meet with the appropriate TFDA regulatory agencies on your behalf throughout the clinical study. We will provide guidance on meeting the Institutional Review Board (IRB) and Independent Ethics Committee (IEC) requirements.
  • Clinical Trials Management
    We can comprehensively manage the clinical trials process by conducting the trials and completing the clinical trial reports. Our experts will evaluate clinical trial and non-clinical trial data; conduct gap analyses; and determine safety and efficacy, along with primary and secondary endpoints, as required for your specific product.
  • Quality Compliance and Audits
    We can conduct on-site audits of your clinical trials and consult on the guidelines for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practices (GVP), Good Quality Practice (GQP), Good Manufacturing Practice (GMP), etc.
  • Adverse Events and Post Market Surveillance
    We will report adverse events and implement suggestions on additional tests and required data. We can assist in post-approval and post-clearance clinical trials to maintain the safety, efficacy, and performance of the product through its life cycle.

Quality

As part of medical device registration process in Taiwan, medical device companies must register their manufacturing facilities by submitting and getting approval for their Quality System Documentation (QSD). QSD registration is only waived for Class I (non-sterile) medical devices. A QSD license (received upon QSD registration approval) in Taiwan, is similar to Good Manufacturing Practice (GMP) for medical devices.

ISO 13485:2016

ISO 13485 quality system standard designed specifically for medical device companies. It is the most commonly chosen path for companies to meet the Quality Management System (QMS) medical device requirements serves as the basis for QMS compliance worldwide.

Advantages of ISO 13485 certification

If you manufacture or market medical devices you will need to be ISO 13485 certified. ISO certification offers many benefits for medical device companies:

  • It is the “de facto” standard for global medical device QMS compliance for medical devices and is a prerequisite for access to most major markets worldwide.
  • ISO 13485 certification requires effort to attain and maintain, so it gives you additional credibility and legitimacy with potential customers.
  • Increased efficiency, better product quality and improved customer service within your company.
  • Your commitment to quality will be evident to your consumers and partners

GRP ISO 13485 Services:

  • Customization of your ISO 13485 quality system to meet your specific needs,
  • Training on ISO 13485 requirements
  • Ensure that your QMS is implemented on time and on budget.
  • Provide qualified recommendations for third-party testing and certification firms that specialize in your category of devices.

Pharmaceuticals

In Taiwan pharmaceuticals are regulated by the Taiwan Food and Drug Administration (TDFA) that rests under the Ministry of Health and wellness (MOHW). Taiwan’s Pharmaceutical Affairs Act regulates the administration of pharmaceutical affairs, which includes drugs and medical devices, pharmaceutical firms, pharmacies, and other relevant matters. Various regulations were established pursuant to the Pharmaceutical Affairs Act to expand on the details not specifically covered in the Act. Pharmaceuticals in Taiwan are regulated into Western and Traditional Chinese Medicine. For Western medicine products, the Taiwanese system classifies them into the following categories: New drugs, generic drugs, bio-pharmaceuticals, substances (active pharmaceutical ingredients), radiopharmaceutical drugs.

 The regulatory process for new pharmaceuticals in Taiwan is often complicated and unclear. Most of Taiwanese regulations are in the Mandarin Chinese language and are constantly being changed by the TFDA health authorities.

Global Regulatory Partners, Inc. (GRP), provides end-to-end regulatory affairs services that allow our clients register their drug, biologic or generic products in Taiwan. Our regulatory services in Taiwan include regulatory intelligence, regulatory strategy, regulatory operations and publishing, products’ registration and products’ life cycle management. GRP has a global presence with a team of local experts and affiliated partners in Taiwan who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your device in Taiwan’s market.

Authorized local agent

Pharmaceutical companies without their own local Taiwan operations and who do not want to use their distributor as their agent can have an independent third party in Taiwan maintain their product registrations in the name of the foreign manufacturer.

The independent third-party agent must be a Taiwan-based entity in order to act as the holder of a medical product registration. The independent third-party agent is responsible for applying to Taiwan’s Department of Health (DOH) for product approval, reporting adverse events, and coordinating recalls. Global Regulatory Partners, Inc. (GRP), can act as your local agent and provide the following services:

GRP Pharmaceutical Services (Taiwan):

  • Communication with the TFDA
  • Assistance with HSA inspections
  • Adverse Effect Reporting
  • Importation of products
  • Organize and support TFDA consultation meetings
  • Product registration
  • Clinical Trial management
  • Support importation process
  • Post-market vigilance
  • Manage Distributors

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.

At Global Regulatory Partners Inc. (GRP), our team of professionals can provide you with tailored Regulatory Intelligence that includes the latest TFDA regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in Taiwan.

Regulatory Strategy

Aimed at foreign manufacturers, the functionality of Taiwan’s pharmaceutical registration process is well-known for its lengthy and time-consuming nature. In certain instances, consultation(s) with the MOHW consultation is a critical step in deeming whether the requirement for clinical trials or bridging studies exist.

GRP Medical Device Regulatory Strategy Services in Taiwan:

  • TFDA Regulatory Background
  • Product Assessment based on TFDA Requirements
  • Device Classification based on TFDA rules
  • Authorized Representation requirements for Taiwan
  • Medical Device Registration Requirements
  • Labeling Requirements
  • Costs and Timeframes
  • Regulatory Roadmap for Taiwan
  • Post-market Surveillance Requirements

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development and registration till commercialization. GRP regulatory affairs services in Taiwan include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product’s registration, products’ life cycle management and maintenance.

Our Regulatory affairs teams help pharmaceutical companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in Taiwan in order to successfully register and commercialize their products in Taiwan’s market and maximize the value of their assets.

Product registration

The Ministry of Health and Welfare (MOHW)  established the Taiwan Food and Drug Agency (TFDA) to implement/apply pharmaceutical regulations. The TFDA is Taiwan’s equivalent of the U.S. FDA. Obtaining TFDA approval is a mandatory requirement for all pharmaceutical imports marketed in Taiwan.

Recent MOHW regulation revision efforts simplified  and streamlined the drug  review process, sequentially increasing the number of high qualities, foreign manufactured drugs entering the Taiwanese market. For instance, Taiwan adopted the Pharmaceutical Inspection Co-operation Scheme (PIC/s) about the PMF; and a Drug Master File (DMF) system, allowing foreign drug manufacturers to register pertaining manufacturing/quality procedures of their APIs to the TFDA. Lastly, for certain drugs, U.S. or EU approvals are now acceptable substitutions for some local requirements.

TFDA New Drug Registration Programs:

Accelerated approval pathway, priority review designation and abbreviated review designation are programs of TFDA which intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.

The new qualifying criteria of accelerated approval, priority review and abbreviated review are as follows:

Accelerated Approval (all criteria need to be met)

  • New chemical entities, new combination, new indication and new administration route.
  • An application for a drug which addresses unmet medical need in the treatment of serious conditions and providing major clinical advance. OR

An application for a drug which addresses unmet medical need with orphan drug designation in advanced countries.

  • An application that demonstrates an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.

Priority Review (meet two of the following criteria)

  • New chemical entities, new combination, new indication and new administration route.
  • An application for a drug which addresses unmet medical need in the treatment of serious conditions and, if approved, would provide major clinical advance.
  • An application for a drug which addresses unmet medical need and is under special national scientific research and development programs.

Abbreviated Review

An application for new chemical entities which fulfills all the following criteria:

  • Approval by two of the three regulatory agencies (US FDA, EMA, or MHLW/PMDA) and with bridging study waiver.
  • Providing full review reports from two of the three regulatory agencies (US FDA, EMA or MHLW/PMDA).
  • Providing Risk Management Plans and updated Post-marketing Commitment reports requested by two of the three regulatory agencies (US FDA, EMA or MHLW/PMDA).

Health Authority Consultation

It is highly recommended to have a pre-consultation meeting with the Taiwan Food and Drug Administration (TFDA), during the development of new pharmaceutical or biologic products. Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.

Pre-NDA Meeting, Pre-ANDA Meeting and Module-Based Rolling Review are new consultation services initiated by TFDA/CDE to accelerate and encourage the new drug development in Taiwan. These new fee-charging services are described below:

Pre-NDA Meeting, Pre-ANDA Meeting

While preparing for new drug application and generic drug application, sponsors might be interested in the basic requirements or TFDA/CDE review processes. The purpose of the Pre-NDA or Pre-ANDA Meeting is to discuss filing and format (CTD format) issues prior to New drug application or abbreviated new drug application (NDA/ANDA) submissions. The meeting also addresses issues that may cause refuse-to-file or hinder the review process. TFDA/CDE can also be aware of upcoming applications and equipped with required resources.

Module-Based Rolling Review

Module-Based Rolling Review is another consultation service provided by the TFDA especially for those cases that have been enrolled in TFDA counseling projects and CDE index cases list, which allowing earlier submission and initiation of review. Sponsors can submit completed sections of its New Drug Application (NDA) or biologics license application (BLA) in CTD format for TFDA/CDE’s review, rather than waiting till all sections of the NDA/BLA are completed.

GRP Health Authority Consultation Services:

Global Regulatory Partners Inc., (GRP) regulatory affairs team has the expertise in preparing consultation meeting with the TFDA before starting key milestone of your product development. GRP regulatory affairs team supports includes: writing, preparation and submission of the meeting package to the TFDA health authority, prepare the questions based on the status of your product’s development and future, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting. 

Medical writing

Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products in Taiwan. As Regulatory authorities, the TFDA, expect precise, clear and well-written documents, any bad writing or translation can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.

Clinical

Local clinical trials must be conducted for certain drugs, such as new and unique drugs, and these trials must follow GCP (Good Clinical Practice) standards. If an imported pharmaceutical has already begun sales in its country of origin and a Free Sales Certificate for the product has been issued, foreign manufacturers are generally allowed to proceed with their clinical trials.

Clinical Trial Requirements:

  1. Designate a Taiwanese medical center or hospital doctor to monitor the trials as an investigator.
    2. Design trial protocol and submit it to the hospital’s ethical committee for approval.
    3. Submit the ethical committee approved trial protocol to the Department of Health (DOH) to obtain its ethical committee’s approval.
    4. Conduct clinical trial under the designated investigator’s control.
    5. Submit a report of the trial to the hospital’s ethical and drug committees for approval.
    6. Submit the trial results to the DOH for approval to obtain a license

Timeline: The procedure of a clinical trial normally takes 2 – 3 years

An understanding of the regulatory requirements in Taiwan and experience in dealing with the local regulatory authorities (TFDA) is essential in administering a smooth, successful clinical trial in Taiwan. Global Regulatory Partners, Inc. (GRP) can act as your contract research organization (CRO) or help you identify a qualified CROs in Taiwan. Our local teams and affiliated partners located in Taiwan and all-around Asia are highly experienced with the related regulatory affairs and can locally manage the full clinical trial process to ensure that it is conducted effectively and successfully.

We offer the following services for medical device and pharmaceutical companies looking to conduct clinical trials in Taiwan:

  • Clinical Trial Consulting Services
    GRP will provide clinical trial consulting services, including consultations with all local government. We can help you develop an effective Clinical Investigation Plan with clinical trial strategy, clinical trial study design, and clinical trial protocol.
  • Regulatory Support
    We can assist with clinical trial applications (CTA) and clinical trial notifications (CTN) as required for clinical trial initiation in Taiwan. Our on-the-ground teams consist of experienced professionals who will meet with the appropriate HSA regulatory agencies on your behalf throughout the clinical study. We will provide guidance on meeting the Institutional Review Board (IRB) and Independent Ethics Committee (IEC) requirements.
  • Clinical Trials Management
    We can comprehensively manage the clinical trials process by conducting the trials and completing the clinical trial reports. Our experts will evaluate clinical trial and non-clinical trial data; conduct gap analyses; and determine safety and efficacy, along with primary and secondary endpoints, as required for your specific product.
  • Quality Compliance and Audits
    We can conduct on-site audits of your clinical trials and consult on the guidelines for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practices (GVP), Good Quality Practice (GQP), Good Manufacturing Practice (GMP), etc.
  • Adverse Events and Post Market Surveillance
    We will report adverse events and implement suggestions on additional tests and required data. We can assist in post-approval and post-clearance clinical trials to maintain the safety, efficacy, and performance of the product through its life cycle.

Clinical trials that are conducted properly in Taiwan will facilitate a smooth registration approval process and expedite access to other Asian markets. If you need assistance with clinical trials for your medical product in Taiwan, contact us for a consultation with our regulatory experts.

Quality

Pharmaceutical Quality Systems for Drugs Products

Pharmaceutical companies are responsible for complying with TFDA regulations to maintain a high level of safety, efficacy and quality of their products. Compliance can be achieved by implementing a pharmaceutical quality system. Adherence to the internal PQS can ensure the identity, strength, quality and purity of drug products by requiring stringent control of every step in the lifecycle. It is important to know CGMPs only are minimum (baseline) standards. A well-designed PQS should exceed these standards

Our Pharmaceutical quality assurance (QA) and regulatory affairs (RA) outsourcing services include:

  • Full consulting GMP quality assurance and regulatory affairs.
  • Audits of your quality management system or a supplier’s quality system.
  • Review of corrective actions and recommendations for resolution.
  • Supporting quality metrics and analysis as part of the management review meetings.
  • Internal auditor training, risk management, quality system, or other training needs.
  • Complaint handling, contract review and surveillance audits.
  • Document control and maintenance of the quality system.

Nutraceuticals

In Taiwan, Nutraceuticals are known as health food products that offer health maintenance benefits (similar to the structure function claims) where the products promote the overall health or reduce the risk of disease or illness. Health foods are not therapeutic products and must comply with safety standards and their ingredients must be known to have a proven health benefit. Health food products are regulated by the “Taiwan Health Foods Control Act” (HFCA). Under HFCA, products can be classified as food, health food or medicine.

Before being sold in Taiwan, Health food products must be registered and must comply with Good Manufacturing Practices (GMP) of the country of origin. Manufacturers must provide the authorities with the list of ingredients, specifications, functions and effects of the health food, together with a summary of the manufacturing process, quality standards and any other relevant data. The product label and sample must also be provided.

Global Regulatory Partners, Inc,. (GRP) has a team of experts in Taiwan who can help Nutraceutical and food supplements companies in Taiwan during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers and are within the daily dose limits allowed by local regulations. The team also reviews and validate the content of the products labeling and packaging and makes sure that nutrient content claims and health claims made by the manufacturer are validated and supported by scientific data before any products’ commercialization.

Authorized local agent

Global Regulatory Partners, Inc, (GRP) has a team of experts who helps Nutraceutical and dietary supplements companies worldwide to register and commercialize their products in compliance with TFDA regulatory requirements in terms of labelling , packaging, nutrient content claims and health claims. GRP has local offices and strategic partners worldwide who can help you register and commercialize your complementary medicine in the Indian market.

GRP Nutraceutical Services (Taiwan):

  • Regulatory intelligence
  • Regulatory strategy
  • Regulatory affairs
  • Product Registration
  • Verification of Nutrient Content Claims
  • Verification of Health Claims

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization in Taiwan. GRP experts can collect the regulatory and other important requirements applicable from TFDA to your product such as: registration dossier, claims, prohibited list of ingredients, importation regulations, specification of ingredients and labeling requirements that are needed to establish the correct strategy for your product commercialization in Taiwan’s market.

Regulatory Strategy

Developing the right regulatory strategy for your Nutraceuticals in different markets is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of Nutraceuticals for the Indian markets. GRP strategy will help you meet your business objectives and goals and reduce your risk of failure. In developing the regulatory strategy, our team takes into consideration different factors such as information on your products and similar products on the market, your product development status and milestones, your business goals, your timelines, the regulatory requirements related to your product, cost, and risks.

With a global presence and a local team of experts, GRP regulatory strategy will help forecast your Nutraceutical launch and commercialization with confidence.

Regulatory Affairs

Global regulatory Partner, Inc. (GRP) provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services in Taiwan include regulatory intelligence, regulatory strategy, labelling , packaging, nutrient content claims and health claims.

Our Regulatory affairs teams can help nutraceutical and dietary supplements companies understand and efficiently manage the demanding complexity of the TFDA Regulatory requirements in order to successfully register and commercialize their products in the Indian market and maximize the value of their assets.

Verification of Nutrient Content Claims

Nutritional claims are those that state, suggest or imply that a food has some particular- beneficial nutritional properties. A nutritional claim suggests a food has beneficial nutritional properties, such as “low fat”. A Claim is a statement that suggests a relationship between food and health. For instance, a Food can “help lower cholesterol.” This information helps consumers to take an informed decision about whether to purchase and consume the product or not. In addition, the TFDA regulations have certain rules governing the provision of voluntary nutrition information, particularly for the front of pack labeling, the nutritional labeling of non-pre-packaged foods and the labeling of energy drinks. Some nutrients are now prohibited to be declared.

Verification of Health Claims

Health claims are directed to the general population or designated subgroups (e.g., the elderly) and are intended to assist the consumer in maintaining healthful dietary practices. The marketing and advertising of food supplements in Taiwan is regulated to be conducted in a manner that promotes the quality use of the product, is socially responsible and does not mislead or deceive the consumer.

Global Regulatory Partners Inc. (GRP), team has the expertise in reviewing and validating the health claims that you are making for you nutraceutical products or dietary supplements in Taiwan to make sure that they are supported by scientific data, are accurate and can be accepted by TFDA health authorities. 

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