Registration of medical device in Vietnam

What are most important legislatives of medical device in Vietnam?

Department of Health (DoH) and Infrastructure and Medical Device Administration (IMDA), under the Ministry of Health (MOH) in Vietnam are responsible for the management of medical devices in class A, B, C and D.

The highest law is Decree No. 98/2021, Decree No. 07/2023, and Decree No. 96/2023. Other specific guidance are Decree No. 43/2017 and No. 111/2021 on goods labelling, including the medical devices.

What is interactive role of legal representative and Vietnam distributor?

A distributor usually acts as registrant and is responsible for registration and circulation issues of the medical devices, under the authorization from the Product owner (Legal manufacturer). There is no mandatory requirement to establish a legal representative in Vietnam. However, a legal representative can hold the license and authorize other companies for the importation and business services.

International rule of thumb

If you have concerns of change of distributor, underscore it in contract or assign a neutral legal representative as consulting.

How was it if manufacturer has CE or MDSAP certificate?

Not only MDSAP countries US, Canada, Japan, Brazil and Australia, but also EU, Swiss, China and Korea is under expedited (fast track) review.

It means that

At least one of certificate in above markets is sufficient wherever manufacturer come froms
The review is 3 months quicker
The technical documentation is simplified
MDSAP certificate as for quality management system only has no impact

For registration of class C and class D products in Vietnam:

MDSAP certificate: No expedited review.
Technical review will be post-audit in case fast-track approval.
To apply for fast-track approval, at least one FSC or marketing authorization (MA) from: US FDA; TGA-Australia, Health Canada, MHLW/ PMDA-Japan, EU members, Switzerland, UK, NMPA-China, MFDS-Korea need to be provided.

How to class medical device in Vietnam?

There are four classes of medical devices: A, B, C and D.

Legal basis: Decree 98/2021 and Circular No. 05/2022.

The classification guideline is similar to in EU with 16 rules derived from medical device directive under ASEAN.

So general speaking the classification of subject is in all ASEAN countries Brunei Darussalam, the Kingdom of Cambodia, the Republic of Indonesia, the Lao People’s Democratic Republic, Malaysia, the Republic of the Union of Myanmar, the Republic of the Philippines, the Republic of Singapore, the Kingdom of Thailand and the Socialist Republic of Vietnam the same.

What is typical technical documentation to submit?

The typical technical documentations for complex class C and D medical device are in following whereas for class A and B is straightforward:

Documentation

ISO 13485

Letter of Authorization (LOA)

Certificate of Warranty Egibility (CWE), or Non-warranty statement/ Single use document

FSC/ MA for imported medical devices

Vietnam quality inspection certificate (For IVDs), or

Documents for exempt from inspection*

Vietnamese IFU and labels

English IFU (if any)

Technical document in ASEAN CSDT template

CSDT Certificate from the appointed organizations

*Post MA in Vietnam, or FSC/MA from reference countries/agencies, except the IVDD FSC for non-List A or non-List B products

What is labelling of medical device in Vietnam?

Pursuant to Decree No. 43/2017 and No. 111/2021 on goods labelling.

International measurement:

As Vietnamese labelling is special in Vietnamese, it is a kind of additional IFU and label to make pursuant to the Decree.

Country of origin?

FSC/MA, label, invoice, or certificate of origin. Country of origin is compulsory on the label while doing customs clearance.

Cost and time to register medical device in Vietnam

Class A US$40, Immediately after successful fee payment check

Class B US$120, Immediately after successful fee payment check

Class C US$240, > 1 year

Class D US$240, > 1 year.

In general, for class A and B medical devices, the approval is straightforward. In opposite, the review of class C and D is extensive with demanding deficiency.

For class C and D, the regulatory appraisal time is 10 – 45 working days from the receipt, however, the actual approval time is affected by processing queues.

What are post market activities?

The regulation of change assessment and vigilance are:

Decree 98, Article 28 and 32

Decree 98, Article 33-37

Summarised is approval of class C and D of medical device extensive due to review time at authority. However the obligatory action for post market is simplified.

The typical changes for a quick notification are:

Name or address of license holder or legal manufacturer;
Change the label or the instructions for use but do not change the intended use, indications for use, features, and/or performance of the medical devices.

The typical design changes for a new change registration are:

Production sites, license holder or legal manufacturer;
Intended use, indications for use.

The typical post market activities for marketing medical devices:

Registration records;
Distribution records (except for representative office);
Records of adverse events, complaints and remedial measures;
Dossiers of medical device quality management, including origin tracking, inspection (if applicable), repair, maintenance and warranty, etc.

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