Registration of medical device in Taiwan

Background of medical device branch in Taiwan

Taiwan is not huge in term of geography however one of the important market in Asia for most manufacturer. The market size was 2.7 billion $ in 2021 with 3% grow rate. Overseas manufacturer should not ignore Taiwan market with moderate registration demand, awareness of heath and an increased aging population.

There is predicate cost and time at site of authority. The language of submission dossier is in English. Taiwan registration has some Asian characters in term of structure of authority, legislative, however from the art of classification of products and quality management they are very western. For example for some of notified body in EU, Taiwan is a critical part at MDSAP inspection. So better to have a compliant Taiwanese QM and prepare technical documentation for product registration with same emphasis.

The responsible authority for food, drug, medical device and cosmetics is Taiwan Food and Drug Administration (TFDA) which is an important organisation of ministry of health and welfare. With the mission of "Safe and Effective Medicine, Safe and Healthy Food" and the vision of "Guardian of Food and Drug Safety Trusted by the Whole People, Creating a Safe Food and Drug Consumption Environment", the Department has established a sound food and drug safety management system and fulfilled the commitment of the Ministry of Health and Welfare to promote the health and well-being of the whole people. Under TFDA, the “center for drug evaluation” is similar like Center for Devices and Radiological Health in US under which devision of medical device make technical dossier evaluation and regulatory consultation.

The important regulation is medical device act under the Presidential Decree in 2021. There are 85 articles and 9 chapters.

The lifecycle of medical device in Taiwan is nicely illustrated by TFDA. The start is to classify your products and to search a local representative. For premarket application you might check whether a clinical trial is needed and which testing is required in the preparation stage. In parallel Quality System Documentation (QSD same as GMP or QM) should be applied. At post market surveillance it is obligatory to follow vigilance, safety surveillance (some high risk classes), good distribution practise and to implement UDI.



Premarket analysis of medical device in Taiwan

The prerequisite to mark medical device in Taiwan is home country approval. For registration you have to submit free sales certificate.

Time and cost to register product in Taiwan

There are initial-, change registration and renewal in Taiwan. It is clear regulated regarding time and cost in term of these registrations (class I, II and III) as well QSD, determination of classification and innovative medical device. The time below in table is calendar day from the review of authority.

Classification of medical device in Taiwan

There are 3 classifications for medical device in Taiwan: I (low risk), II (medium risk) and III (high risk). The classification can be matched with identification. The classification alphabetic character (A-P) plus 4 numbers is corresponding relevant classification. So there are 16 categories (classification number) according to their function, intended use, operating instructions, and working principle, depending on the applicable medical specialty:

·        Clinical chemistry and clinical toxicology devices

·        Hematology, pathology, and genetics devices

·        Immunology and microbiology devices

·        Anesthesiology devices

·        Cardiovascular devices

·        Dental devices

·        Ear, nose, and throat devices

·        Gastroenterology and urology devices

·        General, plastic surgery, and dermatology devices

·        General hospital and personal use devices

·        Neurological devices

·        Obstetrical and gynecological devices

·        Ophthalmic devices

·        Orthopedic devices

·        Physical medicine devices

·        Radiology devices

If the classification of medical device is difficult or impossible to define, an application for determination for product classification can be made.

Local legal representative of medical device        

To register medical device, it is essential to have a local representative. In some other countries it called Chinese agent, US agent, marketing authorisation holder in Japan or authorised representative in EU.

The local representative should have business license and medical device business permit. The role of local representative is universal the registration of dossier, communication with authority and oversee post market activities-

Premarket preparation to register medical device in Taiwan

Technical Dossier (application documents of class II and III medical device)

The following documents are needed as submission dossier:

·        Free sales certificate

·        Authorisation letter

·        Test specification and methods

·        Clinical evidence

·        Radiation safety information

·        Essential requirement

·        Label, IFU and packaging

·        Original licence

·        Quality management certificate

·        Product structures, materials, specifications, functions, intended uses and drawings

·        Test specifications and methods of preclinical testing and quality control

Testing (e.g. NCC)

The most demanding testing is for products with wireless function. You`d better to have wireless components with new valid certificate under “national communication commission” (NCC). In this case you have to transfer the authorisation of medical device using wireless technology to local distributor. Otherwise you have to test the single wireless module and hardware. It is similar to FCC in US/Canada, RED in EU, MIC in Japan and KC in Korea. There are different accredited laboratory in Taiwan which make wireless tests. Plan the test independently to product registration so save for market entry in Taiwan.

We can be your interim testing project manager from application, plan to final certification.

Labelling

According to the “Medical Devices Act” Article 32, medical device firms that manufacture or import medical devices shall attach labels in traditional Chinese to the smallest packaging unit for sale and provide Chinese instructions before engaging in the sale, wholesale, and retail.

The following particulars shall be indicated on the labels, instructions, or packaging of medical devices:

1. Product name.

2. License number or listing number.

3. Effectiveness, intended use, or indications.

4. Date of manufacture and shelf-life or expiration date.

5. Model number, specifications, or major components.

6. Warnings, cautions, use limitations, or expected and foreseeable side effects.

7. Name and address of the license holder or the person who completed the listing.

8. Name and address of the manufacturer.

9. Lot number or serial number.

10. Other particulars that shall be indicated as announced by the central competent authority.

Instruction for use must be in traditional Chinese. The contents may include product description, indications/intended use (or purpose and function), warnings or precautions, side effects or complications, contraindications, model number and specifications. If the product involves accessories, the model number, quantity, and specification of accessories shall also be prepared. Contraindications, warnings, side effects and precautions must be accounted in detail and accurately, printed in rubic or boldtype font, or highlighted with a red frame.

We can control your international instructional for use fulfilling all country specific requirements.

Postmarket surveillance of medical device in Taiwan

So far there is only typical vigilance in Taiwan for all overseas manufactures. Only for some high risk classes there is safety surveillance report. Besides it, overseas manufacturers have to register UDI, make renewal for QSD, and take account of product design change during the next development of products.

Quality System Documentation (QSD) of medical device in Taiwan

Quality System Documentation is actually a premarket and continuous post market activity. The quality management certificate at product registration is not sufficient. Every 3 years you have to update quality management system in term of remote paper inspection.

QSD in Taiwan applies to all class II, III and some of class I medical device.

*for

There are simplified documents for TW-QSD if legal manufacturer has recent inspection audit in

• EU/swiss/Lichtenstein (Only applicable for manufacturers located in countries of European Union and limited to EU Notified Bodies which participate in the “Technical Cooperation Program on Exchange of Audit Reports between EU and Taiwan”, or also applicable for countries/regions that have signed cooperative agreements with Taiwan),
• Japan
• US

Otherwise standard mode is required:

·        Application form

·        Quality system management as ISO 13485 or ISO 9001 or GMP at FDA (name revising:(

·        Quality manual

·        Quality system procedural documents

·        Plant layout diagram

·        Layout of production area

·        Main manufacturing equipment and main testing equipment

·        Manufacturing process diagram

• Device Master Record

The last essential mode is also a kind of simplified dossier for which a list can be found at article 78  at

Medical Device Quality Management System Regulations (2021)

The certificate of QSD is 3 years. It is recommended to submit the next renewal six months prior to expiration of certificate.

Besides remote inspection every 3 years by Taiwan authority, the legal manufactures has to show compliant process and records at annual MDSAP inspection often.

Do you know due to Technical Cooperation Programme on Exchange of Medical Device Quality Management System Regulation and ISO 13485 Audit Reports it is possible to get QSD certification for Taiwan at notified body in Europe?

Manufacturer has to expand scope of ISO 13485 covering special QM requirements in Taiwan only.

So far the following notified bodies are in the list:

1 Netherlands

DEKRA Certification B.V.

Notified Body 0344

2 France

GMED

Notified Body 0459

3 Germany

mdc medical device certification GmbH

Notified Body 0483

4 Germany

MEDCERT Prüfungs-und Zertifizierungsgesellschaft

für die Medizin GmbH

Notified Body 0482

5 Germany

TÜV Rheinland LGA Products GmbH (TRLP)

Notified Body 0197

6 Germany

TÜV SÜD Product Service GmbH

Notified Body 0123

We have close cooperation with some notified bodies in Germany and France. Contact us to keep QSD certificaion for Taiwan compliance and save inconvenience to apply QSD in Taiwan.

Do you know that without approval of renewal of quality management, manufacturer couldn`t import medical device till approval? QMS is categorised most likely risks in some countries for commercialisation of medical device.

With our global experience Device Master Record expecially for European manufacturer is one of the challenging documents which will be prepared more than 2 months including often deficiency reply by authority.

Below is one given example of Device Master Record für Taiwan.

Contact us for

Templates of QSD in Taiwan

Global registration of medical device and quality management

eLearning of global registration



UDI in Taiwan

The applied article of UDI is Nr.33 of the medical device act. TFDA announced that starting from June 1, 2022. License holders of Class III medical devices are required to upload UDI and corresponding product information to the UDI Database (UDID). Medical device manufacturers are also required to place UDI on the product label. In addition, starting from June 1, 2023, Class II medical devices are required to meet relevant regulations of UDI.

The regulation stipulates also the attribute to register in Taiwan UDID database.

Vigilance of medical device

Besides inofficial customer complaints, the legal manufacturer has to actively report serious adverse event and recalls. The regulations were updated in 2021. The deadline to report adverse events are as below:

7 days

Death.

Life-threatening condition.

15 days

Permanent disability.

Congenital anomaly of fetus or infant.

Requiring hospitalization or prolonged hospitalization.

Other complications that may result in permanent injuries.

There are three levels of recalls. There are different deadline to conduct a recall, a notification and to draft a recall plan.

Change assessment of medical device in Taiwan

After initial registration there is a critical post market assessment which is often underestimated: design change. Under significant change of product, you have to start a change registration before marking the new changed products in Taiwan.

The change guidance in Taiwan is quite straightforward without complex deciding trees. You just need to observe the typical significant changes as

·        Chinese or English product name

·        IFU, labelling and packaging

·        Increase or decrease of variants

·        Enhanced performance

·        manufacturers name

·        Production address

·        New local representative



Important resource to register medical device in Taiwan

https://www.fda.gov.tw/eng/index.aspx

https://www.cde.org.tw/eng

https://www.ncc.gov.tw/english/index.aspx

https://www.ncc.gov.tw/english/

Do you know that with product code in Taiwan you can search regulatory requirements as standards, guidances and even approved competitor?

Do you want to have a professional regulatory affairs eLearning in Taiwan and other markets?

Have a consulting with us for one year eLearning. We have a unique coach who can meet you and answer all questions.

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