Taiwan’s medical device market is one of the most advanced in Asia and it continues to be increasingly sophisticated. The market is worth nearly $900 million, making it Asia’s 4th largest. Taiwan’s domestic industry is growing, but it remains largely fragmented and export-oriented. Nearly 80% of the Taiwanese medical market is made up of imports, with the U.S. contributing more than 30% of that figure.
The R.O.C. Department of Health (DOH)
The DOH is Taiwan’s equivalent of the U.S. FDA. All imported medical devices must obtain a certificate of Taiwan medical device registration from the DOH’s Bureau of Pharmaceutical Affairs (BPA). The DOH performs on-site inspection for local manufacturers and also reviews Quality System Documentation (QSD) provided by foreign manufacturers.
Taiwan Medical Device Registration and Classification
Taiwan divides medical devices into 3 classes:
- Class I: These products only require QSD registration with the DOH.
- Class II: These products require QSD registration and product registration with the DOH.
- Class III: These products require QSD registration and product registration with the DOH. Some Class III products also require a clinical trial or published clinical trial reports.
In order to receive product registration, all foreign manufacturers without local offices must select a Taiwanese trading company as an agent to import medical devices. Taiwan medical device registration requires the submission of at least 6 different documents (some types of medical devices require additional documents). QSD requirements must be met before any product can be registered. QSD requirements are different for U.S. and non-U.S. factories. A company must submit a QSD for all plants if it plans to export products manufactured both inside and outside the U.S.
QSD Registration Procedures for U.S. and Non-U.S. Plants
U.S. Plants: For U.S. plants to obtain QSD registration, the following documentation must be approved by FDA:
- Free Sale Certificate (must cover all products manufactured in the plant)
- Establishment Inspection Report ISO13485 or EN46001
- General information
- Factory name and address
- Brief history
- Organizational chart
- Registered capital
- Plant description (size, location, product manufacturing activities, etc.)
- Product list (name and code of all products manufactured at the plant; any toxic or hazardous substances handled; whether drugs for humans or animals, radiopharmaceuticals, diagnostic reagents, cosmetics, or food products are also manufactured site)
- Layout (drawing of plant, drawing of buildings showing each floor separately with a list of rooms and facilities, flows for personnel and materials coded by color, blueprints(if requested))
- Manufacturing flow chart for products
All of this documentation should be collected in one file and sent to the DOH.
Non-U.S. Plants: For Non-U.S. plants, all of the documents needed for U.S. plants to obtain QSD registration are required, plus the following:
- Master index
- List of all Standard Operating Procedure (SOP) numbers and document description
- List of Level III SOP numbers and document description (this is not necessary for the first submission but must be submitted if requested by the DOH)
- Quality Manual of the plant
- Contents must cover all 20 points required by QSD
- All of this documentation should be collected in one file and sent to the DOH
Required Documentation for Medical Device Product Registration
The following is a list of required documentation necessary to obtain Taiwan medical device registration:
- Letter of Authorization (given to Taiwanese agent in order to authorize registration)
- Free Sale Certificate (demonstrates that the product is freely sold in its home market)
- Leaflet/Catalogue (specifying product usage – 3 copies are required)
- Quality control (including testing methods and testing results)
- Product Specifications (form, structure, dimensions, raw materials or ingredients, quantity, performance, purpose of use, and effects)
- Sample (if device is extremely heavy or bulky, or if other special circumstances apply, sample may be replaced by pictures that identify the structure, properties, and form of the device)
- Clinical trial reports (required for certain medical devices or approved devices such as newly developed devices or approved devices with new applications)
- Circuits and testing records of electric insulation and duration (required for electronic equipment)
- Instructions for operating security (required for electronic equipment)
- Operation records of automatic measurement adjustment (required for automatic temperature adjusting equipment)
- Testing record and certificate of radiation leakage (required for radioactive equipment)
General Information on Product Registration
The application process for Taiwan medical device registration can take 1-2 years. Licenses granted by the DOH are valid for 5 years. The Taiwanese agent who is authorized to register the product becomes the license-holder. After the license is granted, the product is allowed to be imported by the agent. The license holder may transfer the license to another agent with the consent of the manufacturer. Manufacturers have the ability to authorize other agents to register the same product concurrently. Manufacturers with different locations but the same company name, (e.g. branch manufacturers) must file separate applications.
The DOH has implemented medical device GMP requirements since 1999. New GMP requirements based on ISO9001 and ISO13485 came into effect in February 2004. All manufacturers must comply with Taiwanese GMP requirements (as outlined in the QSD section)
Recent DOH Regulations Affecting Taiwan’s Medical Device Market
- 12/31/2003: In response to mad cow disease (BSE), the DOH will not accept drug or medical device registration in cases where bovine derivatives from BSE countries listed by the World Organization for Animal Health or Taiwan were used in production.
- The grace period for IVD (In Vitro Diagnostics) reclassification and registration ended on February 9, 2004. Taiwan medical device registration documents are required for product renewal or for new products. All IVDs on market should be properly licensed by June 20, 2005.
- DOH published a draft of revised reclassification and registration requirements for medical devices in April 2004. Some previously exempt Class I products must be registered (previously all Class I products were exempt from product registration). Class I products requiring registration will only need “simple documents, but this will still increase workload significantly.
- New sub-categories to the three classes of devices (Class I, II, and III) will reclassify several medical devices. DOH will finalize the regulation after receiving feedback from the medical industry.
- DOH published a draft announcement on Post Marketing Surveillance (PMS) regulation of new drugs and medical devices in June 2004. The announcement has undergone industry review. When it becomes effective, medical devices designated by DOH will be subject to the PMS regulation for 3 years after a license is granted.
- August 2004: DOH made announcement on the Exchange of Letter (EOL) with the Quality Auditing Parties of the EU. The announcement recognizes the following 6 parties within the EU: TÜV PS, TÜV Rhineland, mdc, NSAI, BSI, and G-Med. Plants in EU countries that are certified by one of these 6 parties will have simplified QSD Taiwan medical device registration requirements (Like U.S. plants that have been FDA inspected).