Medical device importation to Vietnam

Only registered medical devices may be imported into Vietnam, that means they must be registered with the Department of Medical Equipment and Construction (DMEC) of the Vietnamese Ministry of Health (MoH) and been issued with a Notification of Applicable Standard or Circulation Registration Certificate unless exempted from registration (see below). All medical devices and in-vitro diagnostics that are in circulation in Vietnam as well as those that are exported are listed in the DMEC portal system.

What are the requirements for importing medical devices into Vietnam?

In order to import a medical device into Vietnam, a company must first obtain a valid Establishment License from the Department of Planning and Investment; only Vietnamese companies can apply for an establishment license
Importers may also require a valid Certificate of Medical Device Trading for classes B, C and D
The relevant product license issued by Department of Medical Equipment and Construction is also required prior to importation. This is issued once the medical device has been notified or registered according to its classification.
Class A and B medical devices require the Notification of Applicable Standard as proof of notification prior to import Class C and D medical devices require a Circulation Registration Certificate as proof of registration prior to import – see next point Medical devices listed in Appendix 1, Circular 30/2015/TT-BYT, currently require an additional Import License issued by the DMEC in order to gain customs clearance. This requirement is for all imports of medical devices on the list up until 31st December 2022 when new rules will enter into force requiring all Class C and D medical devices to simply obtain a product license.
Multiple importers of the same medical device are allowed in Vietnam but please note that each importer must register the device separately to obtain the relevant product license and import license if applicable. Every time you register the device it will be evaluated as a new device application and therefore the registration fees are applicable each time
Please note that transfers of product licenses are not allowed in Vietnam; therefore, it can prove judicious to appoint an independent local authorized representative to register and import your medical device giving you freedom in your distribution strategy; you may even appoint multiple distributors
Certain medical devices may require additional licenses from the Ministry of Information and Communication such as for wifi/bluetooth connections prior to import
Medical devices which are measurement instruments require additional documentation such as sample approval, inspection and calibration under Ministry of Science and Technology responsibility.

Are there any exemptions or exclusions?

Special Access Routes for importing medical devices into Vietnam

Importers duties and obligations

It is mandatory for importers of medical devices and IVDs to Vietnam to store the following quality control documents:

Importers must also:

maintain a valid Importer’s Establishment Licence
a valid Certificate of Medical Device Trading for classes B, C and D if applicable
maintain a record of all imports (and exports)
provide appropriate storage conditions and means of transportation to maintain the safety and quality of imported products
have a system to monitor and manage the export, import and inventory of medical equipment containing narcotics and precursors if applicable
maintain records of any complaints
report any Adverse Events (AE) or other Post marketing surveillance activities to the Vietnamese Ministry of Health.

How Andaman Medical can help with importing medical devices to Vietnam:

Andaman Medical holds a valid license to operate as an importer of medical device and in-vitro diagnostics as well as being able to authorize other third parties to import medical devices and in-vitro diagnostics. We remain independent from any final distribution channel partner you choose to appoint, giving you freedom in your distribution strategy, you may even appoint multiple distributors. Our regulatory affairs specialists and logistics executives will help you to:

register and import your medical device
ensure that your product registrations are valid at all times.
keep you abreast on the recent changes or new regulations pertaining to medical devices
facilitate customs clearance
maintain post-market surveillance of your registered product
liaise with your appointed distributors and the Vietnamese Ministry of Health concerning the mandatory reporting of Adverse Effects and other Post marketing surveillance activities.

We also offer additional support services such as:

Obtain a quote on accessing the Vietnamese medical device market

Medical device distribution in Vietnam

Only registered medical devices may be distributed in Vietnam, that means they must be registered with the Department of Medical Equipment and Construction (DMEC) of the Vietnamese Ministry of Health (MoH) and been issued with a Notification of Applicable Standard or Circulation Registration Certificate also known as the Product License unless exempted from registration (see below). All medical devices and in-vitro diagnostics that are in circulation in Vietnam as well as those that are exported are listed in the DMEC portal system.

Who can distribute medical devices in Vietnam?

Only Vietnamese companies that hold a valid Establishment License may distribute medical devices in Vietnam.
What is important to remember is that multiple distributors may be appointed in Vietnam. Even though a company must have a valid Establishment License to distribute, this same company does not necessarily have to be the Product License Holder. So, to take full advantage of having multiple distributors at a lower cost, you can appoint a Local Authorized Representative (LAR) who will register, import and act as a master distributor for your medical devices, which means that you only need to register your medical devices once. As master distributor, the LAR works alongside your final distribution channel partners to get your product to the end-user.
If issues arise with a distributor who is also your product license holder, there is no possibility to change ownership or transfer the Product Approval License to new company. A new registration will be required, leading to higher costs and lengthy delays, especially during this period of regulatory transition towards product licenses for class C and class D medical devices ( from January 2023). Hence the advantage of appointing an independent third party or Local Authorized Representative (LAR) as the Product License Holder.
Choosing to work with an LAR rather than directly with a distributor gives you real flexibility in your distribution strategy. This means you can adapt quickly to changes in the market by adding new distributors, increase transfer pricing as well as ensuring rigorous quality and compliance controls continue post-market.
It is vital to choose the correct partner as they are responsible for registering, importing and distributing your medical device to your customers or channel partners.

What are the requirements for distributing medical devices in Vietnam?

In order to distribute a medical device into Vietnam, a company must first obtain a valid Establishment License from the Department of Planning and Investment; only Vietnamese companies can apply for an establishment license
Distributor must also have a valid Certificate of Medical Device Trading for classes B, C and D
The relevant product license issued by the Department of Medical Equipment and Construction of the Ministry of Health is also required prior to distribution. This is issued once the medical device has been notified or registered according to its classification.
Class A and class B medical devices require a Notification of Applicable Standard as proof of notification prior to distribution
Class C and class D medical devices require a Circulation Registration Certificate (Product License) as proof of registration prior to distribution
And the valid Import License for those medical devices listed in Appendix 1, Circular 30/2015/TT-BYT; the Import License effectively has the same role as a product license and so is required for distribution purposes. (Note: the import license will be valid until 31 Dec 2022)

Advertising rules

Advertising, communication and promotion of medical device is a common part of a distribution contract. In Vietnam, the promotion and marketing of medical devices must comply with Decree 98/2021/ND-CP . Only the License Holder or those entities who are authorized by the License Holder may declare the information of the advertising content to the DMEC prior to the promotion and marketing of medical devices. The contents of promotion and advertising must be consistent with the Notification of Applicable Standard dossier of class A and class B medical devices and the Circulation Registration dossier of class C and D medical devices.

Distributor’s duties and obligations

It is mandatory for distributors of medical devices and IVDs to Vietnam to store the following quality control documents:

Distributors must also:

maintain a valid Establishment Licence
a valid Certificate of Medical Device Trading for classes B, C and D if applicable
provide appropriate storage conditions and means of transportation to maintain the safety and quality of distributed products
have a system to monitor and manage the export, import and inventory of medical equipment containing narcotics and precursors if applicable
maintain records of any complaints
report any Adverse Events (AE) or other Post marketing surveillance activities to the Vietnamese Ministry of Health.

How Andaman Medical can help with distributing medical devices to Vietnam:

Andaman Medical holds a valid license to operate as an importer and master distributor of medical device and in-vitro diagnostics as well as being able to authorize other third parties to import and distribute medical devices and IVDs. We remain independent from any final distribution channel partner you choose to appoint, giving you freedom in your distribution strategy, you may even appoint multiple distributors. Our regulatory affairs specialists and logistics executives will help you to:

register and import your medical device
ensure that your product registrations are valid at all times
ensure your product is correctly labelled
keep you abreast on the recent changes or new regulations pertaining to medical devices
facilitate customs clearance
maintain post-market surveillance of your registered product
liaise with your appointed distributors and the Vietnamese Ministry of Health concerning the mandatory reporting of Adverse Effects and other Post marketing surveillance activities.

We also offer additional support services such as:

Get a quote on our how we can help you access the Vietnam medical device market

Medical device registration in Vietnam

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All medical devices, whether manufactured domestically in Vietnam or imported, must be registered with the Department of Medical Equipment and Construction (DMEC) of the Vietnamese Ministry of Health.

Who can register a medical device in Vietnam?

Only companies registered locally in Vietnam and who have a valid Establishment License from the Local Department of Planning and Investment may register a medical device. These organizations must declare applicable standards or register the circulation of medical devices in Vietnam include:

a) Vietnamese enterprises, cooperatives and household businesses that own medical devices

b) Vietnamese enterprises, cooperatives and household businesses that trade medical devices and are authorized by owners of medical devices to register

c) Standing representative offices in Vietnam of foreign traders who own medical devices or are authorized by owners of medical devices.

As only local (Vietnamese) companies can apply for an establishment license, foreign manufacturers, therefore, have three (3) possibilities to register their medical device in Vietnam:

Appoint an independent third party

such as Andaman Medical to register the medical devices. Andaman Medical has a valid Medical Device Establishment License and is a licensed Local Authorized Representative which means we act directly on behalf of foreign manufacturers and distributors and can register all classes of medical device, A, B, C and D. We register and maintain your device license which means you have the freedom to appoint as many importers or wholesalers for your device as you require while the product license will not be affected by any changes in the distributor network. Andaman Medical is also a licensed importer of medical devices – please refer to our importation of medical devices to Vietnam page for more details.

Classification of medical devices in Vietnam

Medical devices are divided into 2 types:

Medical devices (non-IVDs): includes equipment, tools, materials, implant materials, reagents, in vitro calibration materials and software that simultaneously satisfy all following requirements: Used independently or in combination with each other according to designation of owners of medical devices to serve humans for following purposes: Diagnosis, prevention, monitor, treatment and relief of diseases or injury compensation; Checking, replacement, modification or surgery and physiological process support; Life support or sustainment; Conception control; Sterilization of medical devices, including chemicals used during diagnosis; Provision of information for diagnosis, monitor and treatment via examination of specimens taken from the human bodies.

Medical devices must not use pharmacological, immune or metabolizing mechanisms in or on human bodies in order to achieve its primary intended action however these mechanisms may assist in achieving this purpose.

In vitro diagnostic medical device (IVDs): consists of reagents, calibration materials, control materials, kits, machines, devices or systems that are used independently or in combination with each other as requested by owners thereof to serve examination of specimens taken from the human bodies.

Please note: in this webpage we will use the term medical devices to include medical devices as well as in-vitro diagnostic medical devices.

Medical devices in Vietnam are classified in terms of risk in accordance with the ASEAN Medical Device Directive (AMDD), which lists 4 classes:

Medical device grouping in Vietnam

Medical devices and IVDs can be grouped and registered as one application in order to obtain one medical device registration certificate: Notification of Applicable Standard certificate for Class A and B products or the Circulation Registration Certificate (Product license) for classes C and D. Medical devices that apply for registration as a group will base on:

The grouping categories are as follows:

The registration processes

First of all, the classification risk and result of a medical device should be determined. The classification result will be issued by an applicant/license holder.

Upon determining the classification, class A and B medical device registration applications must be uploaded to the local department of health via online portal https://dmec.moh.gov.vn/. Upon approval a Notification of Applicable Standard will be issued. This has a lifetime validity.

All class C and D medical device registration applications must be submitted to the DMEC via the online portal. Upon approval, a Circulation Registration Certificate (Product license) will be issued. The circulation registration certificate (product license) do not have expiration date/validity. The product license of class C, D will be fully implemented from 1st Jan 2023.

The filing of applications for medical device product registrations shall follow the guidelines under Decree 98/2021/ND-CP. Once the necessary documentation has been uploaded according to the product’s classification and group, the registrant can process the payment at the same time.

What documents are required to register medical devices in Vietnam?

Various documentation, both legal and technical, is required to register a medical device in Vietnam. Legal documents include: Free sale certificate, Letter of authorization, ISO 13485 certificate. Technical documents include the classification result, technical brief, instruction for use (Vietnamese), labelling, catalogue. In addition, the summary of clinical trial data is required for medical device classes C and D invasive in human body.

Medical devices which are measurement instruments require additional documentation such as sample approval, inspection and calibration under Ministry of Science and Technology responsibility.

Typical fees and timelines

A fee is payable for each submission for medical device registrations and import licenses. These are non-tax fees. The fee regulated in Circular 278/2016/TT-BTC.

The registration application for class A and B devices will be approved and signed by the Department of Health where the registrant is located and normally takes about 7-10 working days for approval.

Whereas the registration application for class C and D products are approved and issued by the Department of Medical Equipment and Construction and is estimated about 6 (six) to 12 (twelve) months once the DMEC commences evaluations (see above point in the registration process).

For medical device and IVD new registrations and import licenses:

Class	Fee	Timeline
Class A	1,000,000 VND (~44 USD)	7-10 working days
Class B	3,000,000 VND (~130 USD)	7-10 working days
Class C and Class D	5,000,000 VND (~217 USD)	6-12 months

How Andaman Medical can help:

Andaman Medical is a regulatory affairs and market access consultancy that specializes in the registration, authorized representation, importation and master distribution of medical device and in-vitro diagnostics in Southeast Asia.

Our in-house team of local, experienced regulatory affairs specialists provide unrivalled assistance to medical device manufacturers and distributors alike who benefit from accessing real, on-the-ground expertise.

Our registration services include:

Our authorised representative services include:

We also offer additional support services such as:

Want to know more how we can help you register your products in Vietnam?

Post Market Surveillance of Medical Devices in Vietnam

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The Department of Medical Equipment and Construction (DMEC) of the Ministry of Health (MoH), requires foreign manufacturers to undertake post-market surveillance (PMS) in accordance with the ASEAN Medical Device Directive (AMDD) which came into effect on 1^st January 2015. However, each ASEAN member state is free in implementing these PMS requirements and each country has its own specificities, please read on to understand how post market surveillance is implemented in Vietnam.

What are the medical device PMS requirements in Vietnam?

The MoH issued guidelines for PMS activities which are regulated for by Decree 36 and Decree 169 regarding medical device management. The guidelines specify:

the handling of medical devices that pose serious threats to public health or could possibly lead to the death of users
the handling of cases in which medical devices have caused adverse events affecting the health of users
product rectification and recall of defective medical devices
the disposal of medical devices whose owners or holders of the product registration number no longer manufacture, go bankrupt or cease to exist.

Documentation for after-sale management of medical devices in Vietnam

License Holders must store the following documents:

Letter of Authorisation from the owner of the medical device for organisations applying for circulation
Certificate of Warranty issued by the owner of the medical device, except for disposable medical devices or cases in which warranty services are not required,
Certificate of Free Sale
Logs of adverse events, complaints and remedial measures specifying brand/product names, types, quantities and batch numbers of the medical devices involved, especially those that are defective or unsafe for users.

Importers must store the following quality control documents:

Mandatory reporting responsibilities

License Holders have varying mandatory reporting responsibilities and actions to be undertaken according to the gravity of the incident relating to their medical device.

In cases where medical devices harm users' health, license holders are responsible for:

a) suspending circulation of the medical device
b) informing the Ministry of Health, organizations and individuals distributing and using the medical device in writing. The notice must specify the batch number and the defect that pose harm to health of users and whether or not the defect can be rectified
c) preparing plans to rectify or recall batches of the defective medical device
d) reporting to Ministry of Health after completing any rectification or recall.

In cases where medical devices have caused serious threat to public health or the death of users, license holders are responsible for:

a) informing on the license holders’ website (if it exists), sending notice about the adverse event to facilities that trade or utilize the batches medical devices and to Ministry of Health
b) suspending circulation of the medical device
c) conducting investigations and verification to determine the reason for the case
d) reporting to the Ministry of Health after receiving investigation and verification results. In cases where incidents are identified to be caused by defects of medical devices, specify the defects and whether or not rectification of the defects is possible. Rectify or recall batches of defective medical devices and report to the Ministry of Health after completing rectification or recall.

In cases where medical devices do not cause death of users but pose serious threats to public health license holders are responsible for:

a) informing the Ministry of Health about the incident
b) conducting investigations and verification to determine the reason for the case
c) reporting to the Ministry of Health after receiving investigation and verification results. In cases where incidents are identified to be caused by defects of medical devices, specify the defects and whether or not rectification of the defects is possible. Rectify or recall batches of defective medical devices and report to the Ministry of Health after completing rectification or recall.

After receiving the relevant report from the license holder, the Ministry of Health is responsible for suspending circulation of the concerned medical device batch(es) or for issuing decisions for the recall of defective medical device batch(es).

What are the timelines for adverse event reporting?

All cases should be reported and informed to authorities and medical establishments within 30 days from the date the manufacturer, importer or distributor is made aware of the adverse event.

How Andaman Medical can help you with post-market surveillance in Vietnam

With 6 local offices throughout Southeast Asia, Andaman Medical provides support for your post-market surveillance activities including Adverse Event and Mandatory Reporting. Our local, in-house staff liaise with the Ministry of Health to help you maintain compliance once your medical device is placed on the market. Our services include:

support for your mandatory reporting of Adverse Events and Field Safety Corrective Actions
identify requirements in medical device directives, standards, and guidance documents to ensure effective implementation of a post-market surveillance system
evaluate your PMS data to ensure that existing processes and outputs are fully compliant
monitor and report on any regulatory changes to ensure ongoing compliance

Get a quote on our PMS services in Vietnam

Local authorised representative in Vietnam

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The Ministry of Health in Vietnam requires foreign manufacturers who have not set up their own legal subsidiary to appoint a Local Authorised Representative (LAR), sometimes referred to as the in-country representative or marketing authorization holder.

Andaman Medical has been a local authorized representative in Vietnam since 2017.

What are the requirements for a marketing authorization holder or LAR in Vietnam?

The in-country representative must have an Establishment License and an Investment License
The LAR must create accounts on the DMEC and VSNW websites for medical device and in-vitro diagnostic registration with the Ministry of Health
And in order to carry out their duties for medical devices classes B, C and D, a local authorized representative must apply for eligibility to trade classes B, C and D and obtain the Certificate of Medical Device Trading for classes B, C and D

Can you appoint multiple in-country representatives in Vietnam?

Yes, multiple in-country representatives are allowed in Vietnam but please note that ALL LARs must register the device individually. Every time you register the device it will be evaluated as a new device application and therefore the registration fees are applicable each time
The foreign manufacturer must issue a Letter of Authorisation (LoA) for the registration of medical devices according to the template in Circular 19/2021/TT/BYT dated on 16 Nov 2021.
The LoA has no fixed duration.

How Andaman Medical can help with in-country representation in Vietnam:

As your marketing authorization holder or local authorized representative in Vietnam we will:

registering your product
o importing your product as Andaman Medical is also an Import License Holder
submitting change notifications
ensuring post-market surveillance once your product is authorized and placed in the market, including reporting Adverse Events

facilitate the importation process including customs clearance
maintain communication with appointed distributors
ensure that the appropriate conformity tests have been carried out, if required
ensure that the medical device or IVD is correctly labelled and that information is provided in Vietnamese
accept all calls from the Ministry of Health regarding the foreign manufacturer and its products and liaising accordingly with the foreign manufacturer including scheduling inspection(s) of the manufacturer’s facilities, if required
maintain our office including a telephone and email connection in Vietnam
monitor regulations to alert you to any changes or new regulations applicable to your product

Get a quote for in-country representation services in Vietnam

Vietnam’s Medical Device Market

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The medical device market in Vietnam

The domestic medical device market in Vietnam is forecasted to be worth US$ 1.8 Billion by 2022, with a compound annual growth rate (CAGR) of 9.6% between 2017 and 2022F according to a report by Ken Research
In terms of domestic consumption of medical devices, Vietnam currently imports more than 90% of its needs in medical devices as there are few local manufacturers of sophisticated or specialized devices with most imports coming from Japan, Germany, the USA, China and Singapore
Imports of medical equipment in 2017 totalled US$1.1 billion which comprised mainly diagnostic imaging equipment (X-ray, ultrasound, magnetic resonance imaging, computed tomography scanners) and equipment used for surgery, endoscopy, sterilization, testing and medical waste treatment, according to the Ho Chi Minh City Medical Equipment Association
Domestic manufacture focuses on unsophisticated lower value devices such as scalpels and disposable supplies, though there are more startups developing digital medicine and artificial intelligence solutions
In terms of distribution, there are few nationwide medical device distributors, with the majority being local.

Regulatory authority and laws governing medical devices in Vietnam

Vietnam’s healthcare system

According to Fitch Solutions, Vietnam’s healthcare expenditure was approximately US$17 billion in 2019 which is expected to reach US$23 billion by 2022 with a compound annual growth rate (CAGR) of 10.7% fueled by rapid economic development creating a fast-growing middle class as well as a rapidly ageing population both contributing to an increasing demand for healthcare services
The healthcare system in Vietnam is a mix of public and private whereby individuals pay for medical services themselves at both public and private hospitals.
The Vietnamese government is striving towards a universal healthcare system which is financed through a social health insurance scheme; in 2019 87% of Vietnam’s population (83.6 million) are covered under this scheme according to The ASEAN Post
The main problem faced by the Vietnam healthcare sector is that many hospitals are outdated with much of the existing medical equipment requires replacement. Public hospitals also suffer from chronic overcrowding due to a shortage of qualified medical staff and beds.

Industry associations

Key exhibitions and events

General economic and demographic statistics

Population of 97.3 million in 2020
People aged 65 and over in 2020 constituted around 7.9% of the population; Vietnam has one of the fastest ageing populations in Asia as it expected that almost a third of the population will be 60 or over by 2050 approximately 29 million people according to Help Age International
Communicable diseases impact on morbidity has reduced significantly from 38% in 1996 to a projected 18% in 2026; with cardiovascular diseases now the leading cause of death and disability (stroke and ischaemic heart disease), followed by road traffic accidents according to a report published by the BMJ in 2020
Gross Domestic Product (GDP) growth is calculated to be 6.7% in 2021 and forecasted to continue at this level through to 2025 (6.6%) according to the International Monetary Fund
Unemployment rate of 2.0% in 2020 according to Statista.

Medical device importation to Vietnam

What are the requirements for importing medical devices into Vietnam?

Are there any exemptions or exclusions?

Special Access Routes for importing medical devices into Vietnam

Importers duties and obligations

How Andaman Medical can help with importing medical devices to Vietnam:

We also offer additional support services such as:

Obtain a quote on accessing the Vietnamese medical device market

Medical device distribution in Vietnam

Who can distribute medical devices in Vietnam?

What are the requirements for distributing medical devices in Vietnam?

Advertising rules

Distributor’s duties and obligations

How Andaman Medical can help with distributing medical devices to Vietnam:

We also offer additional support services such as:

Get a quote on our how we can help you access the Vietnam medical device market

Medical device registration in Vietnam

Who can register a medical device in Vietnam?

Set up a legal subsidiary entity

Appoint a local importer or distributor

Appoint an independent third party

Classification of medical devices in Vietnam

Please note: in this webpage we will use the term medical devices to include medical devices as well as in-vitro diagnostic medical devices.

Class A

Class B

Class C

Class D

Medical device grouping in Vietnam

The grouping categories are as follows:

The registration processes

What documents are required to register medical devices in Vietnam?

Typical fees and timelines

For medical device and IVD new registrations and import licenses:

How Andaman Medical can help:

Our registration services include:

Our authorised representative services include:

We also offer additional support services such as:

Want to know more how we can help you register your products in Vietnam?

Post Market Surveillance of Medical Devices in Vietnam

What are the medical device PMS requirements in Vietnam?

Documentation for after-sale management of medical devices in Vietnam

License Holders must store the following documents:

Importers must store the following quality control documents:

Mandatory reporting responsibilities

In cases where medical devices harm users' health, license holders are responsible for:

In cases where medical devices have caused serious threat to public health or the death of users, license holders are responsible for:

In cases where medical devices do not cause death of users but pose serious threats to public health license holders are responsible for:

What are the timelines for adverse event reporting?

How Andaman Medical can help you with post-market surveillance in Vietnam

Get a quote on our PMS services in Vietnam

Local authorised representative in Vietnam

What are the requirements for a marketing authorization holder or LAR in Vietnam?

Can you appoint multiple in-country representatives in Vietnam?

How Andaman Medical can help with in-country representation in Vietnam:

Get a quote for in-country representation services in Vietnam

Vietnam’s Medical Device Market

The medical device market in Vietnam

Regulatory authority and laws governing medical devices in Vietnam

Vietnam’s healthcare system

Industry associations

Key exhibitions and events

General economic and demographic statistics

How Andaman Medical can help you access the Vietnam medical device market

Regulatory Services for Vietnam

Medical Device Registration

Local Authorised Representative

Post Market Surveillance

Intelligence Reports

Training

Market Access Services for Vietnam

Importation

Distribution

Obtain a quote on accessing the Vietnam market

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Copyright 2023 © Andaman Medical | Privacy Policy Web Design by Brilliant Digital

Copyright 2023 © Andaman Medical | Privacy Policy
Web Design by Brilliant Digital

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Web Design by Brilliant Digital