ISO 13485 certification in Vietnam

ISO 13485 certification in Vietnam at a glance

Manufacturing medical devices in Vietnam starts with a quality condition written into Decree No. 98/2021/NĐ-CP: the establishment must meet the ISO 13485 quality management system standard, and its declaration of eligibility to manufacture includes an ISO 13485 certificate issued by a conformity assessment organisation. The same certificate appears in the dossiers for declaring applicable standards for Class A and B devices, and imported devices must come from ISO 13485-certified manufacturing sites. For local producers, importers and contract manufacturers the certificate is therefore a regulatory document as well as a customer expectation. BoA lists medical devices management systems among its IAF MLA programmes, so accredited certification is available within Vietnam. Sterling's Ho Chi Minh City office builds the quality manual, risk management, design and production controls, supplier controls and records with the client, and Effivity and Sterling Academy are included. Questions on the Ministry of Health route follow.

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

For some organisations in Vietnam 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.

• Medical device manufacturing establishments in VietnamDecree 98/2021 requires the ISO 13485 quality management system standard and an ISO 13485 certificate in the declaration of eligibility to manufacture.
• Organisations declaring applicable standards for Class A and B devicesThe dossier includes an ISO 13485 certificate valid at submission.
• Importers and foreign manufacturersImported devices must be produced at an ISO 13485-certified manufacturing site.
• Contract manufacturers and component suppliers in hi-tech parksDevice customers require ISO 13485 from suppliers.

ISO 13485 requirements in Vietnam

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 Vietnam 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 Vietnam

One team from the Ho Chi Minh City office carries the work from scoping to certificate. Delivery across Vietnam from the Ho Chi Minh City office, on-site and remote.

1. Discovery call and scopeEntities, locations, regulators and target date, agreed before any proposal.
2. Gap assessment against ISO 13485 and the Vietnamese 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 Vietnam?

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

• Device classification and design responsibility in scope
• Maturity of risk management, design and production records
• Sterile or measuring functions requiring validated processes
• Scheduling around the Tết break

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 Vietnam?

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 Vietnam these factors move both.

• Number of device families and sites
• Process validation and cleanroom requirements
• Certification body audit fees quoted separately from consulting
• Translation of documents between Vietnamese and English where auditors or parent companies need both

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 Vietnam

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 Vietnam 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 Vietnam: questions clients ask

More on ISO 13485 for Vietnamese organisations

• ISO 13485: the complete guide
• Watch: How to implement ISO 13485
• Sterling in Ho Chi Minh City
• ISO 13485 certification in Vietnam and every other standard Sterling delivers there

Other standards Vietnamese businesses ask Sterling for

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

All 20 standards Sterling delivers in Vietnam →