Looking up a medical device market authorization number helps hospitals, clinics, distributors, and businesses verify key regulatory information about a product before purchasing, selling, receiving it into inventory, or putting it into use. Search results should be cross-checked against the correct device name, category, model, manufacturer, manufacturing facility, market authorization holder, and warranty service provider shown in the product documentation, labeling, and contract. Under current regulations, medical device market authorization numbers do not take a single form.
For Class A and B medical devices, the market authorization number is the applicable standards declaration number. For Class C and D medical devices, it is the market authorization registration certificate number. Users therefore need to identify the correct device classification and document type rather than simply entering a commercial name and concluding whether a product is or is not authorized for circulation.
Quick Summary
- Class A and B medical devices are looked up using the applicable standards declaration number.
- Class C and D medical devices are looked up using the market authorization registration certificate number.
- The device name alone should not be used for verification; the model, authorization holder, manufacturing facility, and warranty service provider should also be checked.
- Failure to find a result on the official portal is not, by itself, sufficient to conclude that a product is non-compliant.
- Before purchasing or accepting equipment, healthcare facilities should retain the search results with the device records for future traceability.
What Is a Medical Device Market Authorization Number?
A market authorization number is regulatory information associated with the declaration or registration of a medical device for circulation in Vietnam. Under Article 21 of Decree No. 98/2021/NĐ-CP and relevant amendments and supplements:
- For Class A and B medical devices, the market authorization number is the applicable standards declaration number.
- For Class C and D medical devices, the market authorization number is the market authorization registration certificate number.
| Device Classification | Market Authorization Information to Look Up |
|---|---|
| Class A | Applicable standards declaration number |
| Class B | Applicable standards declaration number |
| Class C | Market authorization registration certificate number |
| Class D | Market authorization registration certificate number |
The market authorization holder is the organization that submits the applicable standards declaration or is granted the market authorization registration certificate in accordance with regulations. During procurement, the seller's company name does not necessarily have to match the market authorization holder. A company may act as a distributor, agent, or commercially authorized party. Buyers should therefore clearly identify the role of each organization appearing in the documentation.
Why Should Market Authorization Information Be Checked Before Buying or Selling Medical Devices?
Market authorization lookup should not be performed only when an inspection or audit occurs. It should form part of the supplier selection, product approval, and equipment acceptance process.
Verify the Exact Product Being Offered
Two devices with similar commercial names may differ in:
- Model.
- Configuration.
- Accessories.
- Manufacturing facility.
- Intended use.
- Classification.
- Market authorization holder.
If only the product name is checked, a hospital may mistakenly match the product to a different regulatory record.
Reduce Discrepancies Between Documentation and the Actual Product
Search results help procurement teams compare information across:
- Tender documents or quotations.
- Catalogs.
- Product labels.
- Contracts.
- Delivery notes.
- Acceptance records.
- Import documentation, where applicable.
- Warranty documentation.
Differences in model, manufacturer, or authorization holder should not be disregarded simply because the products are described as belonging to the "same product line" or having the "same function."
Identify Responsible Parties
Publicly available information may help healthcare facilities identify:
- Product owner.
- Market authorization holder.
- Manufacturing facility.
- Country of manufacture.
- Warranty service provider.
- Device classification.
These are important points of contact when documentation needs to be verified, warranty service is required, or product alerts need to be addressed.
Support Traceability After the Device Enters Use
If search results are retained with the equipment records, hospitals can quickly cross-check information when:
- The equipment develops a fault.
- The distributor changes.
- An alert or update notice is issued.
- The equipment is transferred.
- Warranty records need to be reviewed.
- The procurement process needs to be reassessed.
Where Can Medical Device Market Authorization Numbers Be Looked Up?
The Ministry of Health's medical device management portal is one of the official sources for looking up declarations, registrations, and other information relating to medical devices. Within the public service results and published document sections, users may be able to search for records such as:
- Applicable standards declarations.
- Market authorization registration numbers.
- Facilities eligible to trade medical devices.
- Warranty service providers.
- Classification results.
- Import licenses.
- Certificates of Free Sale.
- Documents updating information associated with existing records.
The portal currently provides a "Public Service Results" section for searching published documents and other results related to medical device management. Because the interface, section names, and search functions may be updated over time, users should access the official homepage and select the appropriate document category rather than relying on an old bookmarked link.
What Information Should Be Prepared Before Searching?
Searching with a broad keyword such as "ultrasound machine" or "laboratory analyzer" may return too many results. Before beginning, users should collect as much identifying information as possible.
Priority Information
- Declaration number or market authorization registration number.
- Device name.
- Commercial name.
- Model.
- Manufacturer.
- Manufacturing facility.
- Country of manufacture.
- Product owner.
- Market authorization holder.
- Organization named in the filing.
- Classification as Class A, B, C, or D.
Supporting Information
- Intended use.
- Configuration.
- List of models covered by the same record.
- Importer name.
- Warranty service provider.
- Declaration or issuance date.
- Application number.
- Former company name if the organization has changed its registered information.
Ideally, the supplier should provide the market authorization number before the search is performed. If the supplier provides only an unclear screenshot or does not provide the filing number, the procurement team should request additional information rather than attempting to identify the record based on assumptions.
How to Look Up a Medical Device Market Authorization Number
Step 1: Identify the Type of Record to Search
First, determine the device classification:
- Class A and B: search for the applicable standards declaration number.
- Class C and D: search for the market authorization registration certificate number.
If the classification is not yet known, users may review the classification documentation provided by the supplier and compare it with publicly available information. Do not assume that a device with a simple design is always Class A or that a high-value device is necessarily Class C or D. Medical device classification is based on risk level and the applicable classification rules, not solely on price or physical size.
Step 2: Access the Official Portal
From the Ministry of Health's medical device management portal, select the section for public service results or published documents. Depending on the type of record, users may need to choose categories such as:
- Applicable standards declarations.
- Market authorization registration.
- Published documents.
- Administrative procedure results.
- Updated filing information.
Step 3: Search by Market Authorization Number
This is the preferred method because a market authorization number generally produces more precise results than a device name. When entering the number, check that:
- All characters are included.
- Slashes or hyphens are entered correctly.
- There are no unnecessary spaces.
- Letters and numbers have not been confused.
- A classification record number is not being used in place of the market authorization number.
If no result appears, users may try:
- Removing spaces.
- Searching part of the number.
- Rechecking the screenshot or document provided.
- Searching by the authorization holder's name.
- Looking within updated filing records.
Step 4: Search by Device Name or Model
If the market authorization number is not available, users may search by:
- Device name.
- Model.
- Manufacturer.
- Market authorization holder.
- Organization that submitted the declaration.
Short, distinctive keywords are generally more useful. For example, instead of searching for the entire phrase "multiparameter patient monitor for hospital use," users may search sequentially by:
1. Model name.
2. Manufacturer name.
3. Shortened product name.
4. Name of the organization named in the filing.
The Vietnamese name in the regulatory record may differ from the English name used in the catalog. Searching by model can therefore be more useful when the commercial name is inconsistent.
Step 5: Open and Review the Detailed Record
Do not stop after finding a result with a similar name. Open the record and review the details. Key fields to check include:
- Device name.
- Classification.
- Model or list of models.
- Manufacturing facility.
- Country of manufacture.
- Product owner.
- Market authorization holder.
- Warranty service provider.
- Declaration or issuance date.
- Updated information.
- Publicly available attachments.
- Status or details of any changes, where available.
For market authorization registration procedures, publicly disclosed information may include the device name, classification, manufacturing facility, country of manufacture, market authorization number, authorization holder, and warranty service provider.
Step 6: Compare the Record with the Actual Product
Once the correct record is located, compare it with:
- Label on the device.
- Packaging label.
- Model shown on the equipment.
- Serial number.
- Catalog.
- Instructions for use.
- Delivery note.
- Contract.
- Warranty information.
A record with the correct product name but without the actual delivered model is not sufficient to confirm that the device being supplied is covered by that record.
Step 7: Retain Evidence of the Search
Healthcare facilities should retain:
- PDF file or downloaded copy of the record.
- Screenshot of the search result.
- Search date.
- Link to the record.
- Person who performed the search.
- Verification result.
- Any unresolved discrepancies.
- Additional written confirmation from the supplier, where applicable.
Recording the search date is important because company information, addresses, models, or warranty service providers may later be updated.
What Should Be Cross-Checked Between the Search Results and Procurement Documents?
The following table can be used as a reference during the assessment process:
| Information to Compare | Source on the System | Supplier Source | Expected Result |
|---|---|---|---|
| Device name | Declaration or registration record | Quotation, contract, label | No discrepancy that changes product identification |
| Model | Model list or supporting documents | Catalog, device label | Delivered model is covered by the record |
| Manufacturer | Publicly disclosed information | Catalog, CO, or product documentation | Consistent |
| Manufacturing facility | Publicly disclosed information | Supplier documentation | Consistent or supported by explanatory documentation |
| Country of manufacture | Publicly disclosed information | Label, supporting documents | Consistent |
| Market authorization holder | Declaration record | Authorization letter or related documentation | Clearly identifiable |
| Warranty service provider | Publicly disclosed information | Warranty agreement | Consistent with service commitments |
| Classification | Declaration record | Technical documentation | Consistent |
| Intended use | Filing documentation | Catalog and clinical requirements | Appropriate for procurement needs |
| Update status | Updated documents | Latest supplier documentation | Current version is used |
This table is for reference only. Depending on the procurement method and type of device, healthcare facilities may need to review additional legal, technical, or commercial documentation.
Numbers Commonly Confused with a Market Authorization Number
A medical device file may contain several different identifiers. Buyers should distinguish among them.
Device Classification Number
This relates to the classification result and does not automatically replace the applicable standards declaration number or market authorization registration number.
Administrative Application Number
An application number is used to track the submission and processing of an administrative procedure. It is not necessarily the final market authorization number.
Import License Number
An import license has its own scope and applicable conditions. Its number should not automatically be treated as the market authorization registration number.
Certificate of Free Sale Number
A CFS may appear in the documentation for imported products, but it is not a Vietnamese market authorization number.
ISO, CE, or Other Foreign Certificate Numbers
These certificates do not replace market authorization requirements in Vietnam. CE, FDA, or ISO logos shown in a catalog should not be treated as the sole evidence that a product has a Vietnamese market authorization number.
Product Code or Item Number
SKU numbers, catalog numbers, and internal company codes are not market authorization numbers.
What Should You Do If No Result Is Found?
Failure to find a result requires further verification, but it should not immediately be interpreted as evidence that the device is not permitted to circulate.
Recheck the Search Entry
A small error in the filing number may prevent the system from returning results. Check:
- Letters and numbers.
- Separators.
- Spaces.
- Former or current company name.
- Vietnamese and English names.
- Individual models or model groups.
Search by the Organization Named in the Filing
If the number provided by the supplier is unclear, search by:
- Market authorization holder.
- Declaring company.
- Manufacturer.
- Model.
- Shortened device name.
Review Updated Documents
The company may have updated:
- Company name.
- Address.
- Manufacturing facility.
- Product owner.
- Model.
- Label template.
- Warranty service provider.
The original record and subsequent updates should be reviewed together. In practice, the portal includes documents updating declaration records, including changes to names or addresses of authorization holders and manufacturing facilities.
Request an Explanation from the Supplier
The supplier should provide:
- Official search link.
- Copy of the regulatory record.
- Correct declaration or registration number.
- Updated documents, if applicable.
- Evidence that the model is covered by the filing.
- Supporting basis where the product is exempt from the standard declaration or registration process.
Check Exemptions or Transitional Provisions
Regulations provide certain exemptions from applicable standards declaration or market authorization registration requirements, as well as cases handled under transitional provisions or other documentation. The regulatory context of the specific product should therefore be identified before reaching a conclusion. Businesses and healthcare facilities should review current regulations or consult the relevant regulatory authority, legal team, or qualified specialist when the situation is unclear.
What Should Be Done When the Search Information Does Not Match?
The Model Does Not Appear in the Record
Ask the supplier to identify the document or appendix that includes the relevant model. An explanation that it belongs to the "same product line" should not be accepted without supporting documentation.
Manufacturer or Country of Manufacture Is Different
The manufacturing facility may have changed, or the record may have been updated. Request explanatory documentation and review any updated information on the system.
The Market Authorization Holder Is Different from the Seller
This can occur in distribution arrangements. The buyer should verify the relationship between the seller and the market authorization holder through contracts, authorization letters, or other appropriate commercial documentation.
The Warranty Service Provider Differs from the Contract
Clarify:
- Who will directly provide warranty service?
- Has the warranty service provider been confirmed by the authorization holder?
- What is the scope of service?
- What are the response times?
- Where will spare parts be sourced?
Device Names Are Different
Minor translation differences may not change the identity of a product, but differences involving intended use or scope of use require careful assessment.
How Should Market Authorization Lookup Be Integrated into the Procurement Process?
Market authorization information should be checked at several stages, not only before the contract is signed.
Requirements Development Stage
The relevant professional department should clearly define the equipment category, intended use, and documentation requirements.
Supplier Evaluation Stage
Require bidders or suppliers to provide:
- Market authorization number.
- Search link.
- Classification documentation.
- Catalog.
- Manufacturer information.
- Warranty service provider.
- Model list.
Contract Negotiation Stage
The contract should define responsibilities if:
- The regulatory documentation is invalid.
- The delivered model is not covered by the documentation.
- Product information changes.
- The market authorization number is withdrawn or subject to regulatory action.
- The warranty service provider fails to meet its commitments.
- The supplier fails to provide updated documentation.
Delivery and Acceptance Stage
The acceptance team should check the market authorization information again because the actual delivered product may differ from the model originally offered.
Operational Stage
The search results should be retained in the equipment lifecycle records and updated when changes occur.
Checklist Before Purchase or Acceptance
- The supplier has provided an applicable standards declaration number or market authorization registration number.
- The device has been correctly identified as Class A, B, C, or D.
- The record has been located on an official source.
- The device name matches the quotation and contract.
- The delivered model is covered by the regulatory record.
- Manufacturer and manufacturing facility information is consistent.
- Country of manufacture is consistent.
- The market authorization holder has been identified.
- The relationship between the authorization holder and supplier has been identified.
- Warranty information is consistent with the contract.
- Relevant updated documents have been reviewed.
- Labels and catalogs have been cross-checked.
- The search result and search date have been retained.
- Any discrepancies have been explained in writing.
- The documentation has been rechecked at the time of acceptance.
Frequently Asked Questions
Is a Medical Device Market Authorization Number the Same as an Import License Number?
No. These are different types of information. Import licenses apply only in relevant cases and do not automatically replace an applicable standards declaration number or market authorization registration number.
Does a Class A Medical Device Need a Market Authorization Number?
Yes. For a Class A medical device, the market authorization number is the applicable standards declaration number.
Where Can a Class B Medical Device Be Looked Up?
Class B medical devices are also managed through applicable standards declaration numbers. Users should search the corresponding declaration results section on the medical device management portal.
If a Market Authorization Number Cannot Be Found, Does That Mean the Product Cannot Be Sold?
Not necessarily. The search entry, updated information, exemptions, transitional documentation, or other applicable documents should be reviewed first. The supplier should provide a clear basis for the product's regulatory status.
Can One Market Authorization Number Cover Multiple Models?
A single record may include one or multiple models depending on the information declared or registered. The model list and supporting documentation should be reviewed.
Should the Market Authorization Information Be Checked Again During Acceptance?
Yes. The model or configuration actually delivered may differ from the information provided during the quotation stage. Rechecking helps ensure that the actual equipment corresponds to the regulatory documentation that was previously assessed.
This article is provided for informational purposes only and does not replace legal advice or guidance from competent regulatory authorities. Businesses and healthcare facilities should review current regulations at the time of purchasing, selling, importing, and putting medical devices into use.
Cross-Checking Regulatory Documentation and Actual Products at PHARMEDI VIETNAM 2026
Looking up a market authorization number is an important step in verifying the regulatory information of a medical device, but the information shown in the system is most useful when it is compared with the exact product being presented by the supplier or considered for purchase by the healthcare facility. The model, manufacturer, manufacturing facility, market authorization holder, product scope, and warranty service provider are all details that should be clarified before a decision is made. In addition to checking official records, direct discussions with manufacturers or distributors can help purchasing organizations better understand the product, its actual configuration, and the responsibilities of each party throughout distribution, warranty, and technical support.
At PHARMEDI & HEALTHCARE VIETNAM 2026 , the exhibition ecosystem covers a range of categories directly related to procurement and distribution, including medical devices and supplies, hospital equipment, diagnostic technologies, laboratory and testing equipment, and healthcare solutions. The event also connects manufacturers, importers, distributors, and organizations across the healthcare value chain. When evaluating a product at PHARMEDI VIETNAM 2026, hospitals, clinics, and businesses can proactively ask suppliers to clarify key information before proceeding with further assessment:
- The specific device name and model being presented.
- Manufacturer, manufacturing facility, and country of manufacture.
- Device classification and market authorization information in Vietnam.
- List of models or configurations covered by the same declaration or registration.
- The exhibitor's role in the supply chain: manufacturer, importer, distributor, or agent.
- Relationship between the seller and the market authorization holder.
- Organization responsible for warranty and technical support in Vietnam.
- Catalogs, product labels, and technical documentation that can be cross-checked against regulatory records.
- How changes to models, manufacturing facilities, or product information will be handled during the business relationship.
Meeting suppliers directly does not replace the need to search and verify information through official sources . Instead, the two processes complement each other: publicly available data help verify the regulatory basis, while discussions at the exhibition can help purchasing organizations clarify the actual product, scope of supply, and responsibilities of potential partners. In this way, PHARMEDI VIETNAM 2026 provides hospitals and businesses with additional opportunities not only to explore new medical devices and technologies, but also to ask important questions about regulatory documentation, models, origin, and support services before selecting products for procurement, distribution, or use.
Dates:
September 22–24, 2026
Venue:
Saigon Exhibition and Convention Center (SECC), Ho Chi Minh City
Exhibitor Registration:https://pharmed.vn/exhibitor/application-form
Visitor Registration:https://ers-vn.informa-info.com/pha2026?cid=FB
ContactBooth Booking:[email protected] (Thanh Thuý)
Media Support:[email protected] (Anita Pham)
Visitor Support:[email protected] (Ciel Le)