ISO 13485 certification in Taiwan

ISO 13485 certification in Taiwan at a glance

For medical device makers in Taiwan the quality system is a licensing matter before it is a certificate matter. The Medical Devices Act requires manufacturers to establish a quality management system and to pass a compliance inspection by the central authority before manufacture, unless the item is exempt, and the Taiwan Food and Drug Administration runs that assessment for domestic makers and a QSD assessment for foreign makers of imported devices. The Medical Device Quality Management System Regulations are prescribed with reference to ISO 13485, which is why the standard anchors most manufacturers' systems. An ISO 13485 certificate, where a customer wants one, comes from an accredited certification body and does not replace the regulator's inspection. Sterling builds the system and design records for Taiwanese and overseas device makers from its Tokyo office, with Effivity and Sterling Academy included with the engagement.

Who needs ISO 13485 in Taiwan, and what happens without it

For some organisations in Taiwan it is a legal requirement. For most, the question comes from a buyer, a regulator or a partner that wants proof before it signs. These are the organisations that get asked.

• Domestic medical device manufacturersThe Medical Devices Act requires a quality management system and a compliance inspection before manufacture, unless the item is exempt.
• Foreign manufacturers exporting devices to TaiwanTFDA assesses the quality management system of foreign manufacturers of imported devices through QSD conformity assessment.
• Component, software and contract manufacturing suppliersDevice makers pass quality system requirements down to their suppliers.
• Software and electronics firms moving into regulated devicesA regulated device brings the quality management system duty with it.

ISO 13485 requirements in Taiwan

Strip away the vocabulary and ISO 13485 requires a company to prove six things about making medical devices that are safe and work as intended.

In Taiwan these six sit alongside the local laws and regulations listed under drivers below; one system can evidence both. The detail is on the global hub: ISO 13485 explained →

• ISO 13485 requirements, clause by clause in plain language

How to get ISO 13485 certified in Taiwan

One team from the Tokyo office carries the work from scoping to certificate. Clients across Taiwan are served from Sterling's Tokyo office, on-site where the work needs it and remotely otherwise.

1. Discovery call and scopeEntities, locations, regulators and target date, agreed before any proposal.
2. Gap assessment against ISO 13485 and the Taiwanese requirements that apply to youControls you already run for your regulators and customers are reused, not rebuilt.
3. Your system built with your team in EffivityRisks, controls, evidence, incidents and reviews in one live system the auditor can see.
4. Internal audit, management review and corrective actionsYour internal auditors trained by Sterling; the evidence proven before the certification body arrives.
5. Certification body stage 1 and stage 2, then surveillanceAn accredited body audits and decides. Sterling supports the audits and the three-year cycle.

The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements.Sterling does not certify. Certification decisions stay with independent bodies.

• The ISO 13485 certification process, step by step
• ISO 13485 internal audit

How long does ISO 13485 certification take in Taiwan?

There is no standard duration: it depends on your scope and on how much of the system already runs. In Taiwan these are the factors that set the timeline.

• Device classes and number of product families
• Design and development records and risk management files
• Regulatory submission timing with TFDA
• Certification body availability

Sterling agrees a dated plan with you on the discovery call, once the scope is known.

• Scope and timeline estimator

How much does ISO 13485 certification cost in Taiwan?

The cost has two parts: the consulting work to build and prove the system, and the certification body’s audit fees, which are quoted separately. In Taiwan these factors move both.

• Number of sites and device families in scope
• Depth of design control and risk management records
• Certification body fees quoted separately from consulting
• TFDA assessment fees paid to the authority

Sterling gives one customised, all-inclusive proposal after the discovery call, never before the scope is agreed.

• What makes up the cost of ISO 13485

ISO 13485 consultants and certification bodies in Taiwan

Two different organisations are involved. A consultant helps you build the system and prove it works; an accredited certification body then audits or assesses it and decides. Keeping the two separate is what makes the result credible to buyers and regulators.

• Check that the body’s accreditation or approval covers ISO 13485 and your sector, and that its certificates can be verified online.
• Ask the consultant how the local requirements in Taiwan are mapped into the same system, so nothing runs twice.
• Ask for client references in your sector; Sterling’s client letters are available on request.
• Agree who owns the evidence and the tool after the engagement; with Sterling the system stays yours, in Effivity.

ISO 13485 in Taiwan: questions clients ask

More on ISO 13485 for Taiwanese organisations

• ISO 13485: the complete guide
• Watch: How to implement ISO 13485
• ISO 13485 certification in Taiwan and every other standard Sterling delivers there

Other standards Taiwanese businesses ask Sterling for

Organisations in Taiwan often combine ISO 13485 with one of these, under one management system where the scopes allow.

All 22 standards Sterling delivers in Taiwan →