Tiếng Việt
In the context of the growing demand for high-quality medical devices (MDs), the fast-track review mechanism has been implemented by the Ministry of Health to shorten the appraisal timeline for dossiers that meet strict regulatory criteria. However, not all dossiers are eligible for this priority pathway. A clear understanding of the eligibility requirements and proper dossier preparation helps enterprises significantly reduce time and costs while minimizing the risk of dossier rejection.
1. Conditions for a Dossier to Be Considered for the Fast-Track Pathway
To be eligible for fast-track review, a medical device registration dossier must simultaneously satisfy the following key requirements:
1.1. Possession of Market Authorization or Certification from Stringent Regulatory Markets
Fast-track review is only considered for products that have already been authorized for circulation by countries or regulatory authorities with stringent regulatory systems. Documents such as the Certificate of Free Sale (CFS), CE certification, FDA approval, or equivalent authorizations serve as critical evidence that the product has been assessed for safety and performance in accordance with international standards. This significantly reduces the need for extensive re-evaluation of technical documentation in Vietnam.
Fast-track issuance of a medical device registration number applies to one of the following cases:
-
The product has been granted a Certificate of Free Sale (CFS) or Market Authorization by one of the following authorities or jurisdictions:
The U.S. Food and Drug Administration (FDA – USA);
The Therapeutic Goods Administration (TGA – Australia);
Health Canada;
The Ministry of Health, Labour and Welfare (MHLW) or the Pharmaceuticals and Medical Devices Agency (PMDA – Japan);
Member States of the European Union, the United Kingdom, and Switzerland;
The National Medical Products Administration (NMPA – China);
The Ministry of Food and Drug Safety (MFDS – Korea);
or other authorities recognized by the competent Vietnamese regulatory body (hereinafter referred to as “reference countries”). -
The product has previously been granted an Import License, a Registration Number, or a Commercial Market Authorization in Vietnam.
1.2. Complete, Consistent, and Properly Legalized Documentation
All foreign-issued documents must be fully and accurately translated into Vietnamese and must undergo notarization and consular legalization in accordance with regulations governing the recognition of foreign documents.
In practice, common deficiencies include inconsistencies in company names, technical specifications, or signatory titles across different documents. Such discrepancies often lead to dossier rejection and may disqualify the dossier from fast-track consideration.
1.3. Clear and Appropriate Technical Documentation
Safety and performance reports, instructions for use (IFU), labeling documents, and technical descriptions must be comprehensive and fully aligned with the information stated in international market authorizations. A well-structured and coherent technical dossier significantly increases the likelihood of priority review.
2. Key Considerations When Preparing a Medical Device Registration Dossier
A dossier that is standardized from the outset not only shortens the review timeline but also helps avoid unnecessary rounds of supplementation. Enterprises should pay close attention to the following aspects:
2.1. Authorization Letter and Warranty Letter
These documents should be signed by the highest authorized representative or a duly authorized individual.
The signatory’s full name and official title must be clearly stated, without abbreviations, and must be consistent with the manufacturer’s legal and registration records.
Lack of consistency among documents is a common reason for requests for clarification.
2.2. Certificate of Free Sale (CFS)
The CFS must clearly state the manufacturer’s name, product name, product code, and the issuing authority.
If the CFS includes content in less common languages or contains bilingual elements (e.g., seals or annotations), all content must be fully translated into Vietnamese to ensure transparency.
Certain types of CFS have limited value for fast-track consideration; therefore, enterprises should select CFS issued by jurisdictions with appropriate regulatory standards.
2.3. Quality Certifications and Foreign Licenses
All foreign-language documents must be fully translated and notarized, including signatures and seals.
When documents are issued in languages other than English, enterprises are advised to request preliminary draft translations for review prior to finalizing official translations, in order to avoid technical terminology errors.
Key documents such as CE certificates, FDA approvals, or domestic licenses must be carefully checked for certificate numbers, scope of application, and validity periods.
2.4. Consular Legalization Documents
Foreign-issued documents must undergo consular legalization unless exempted under international treaties or reciprocal agreements.
Missing or improperly executed legalization is a frequent cause of dossier rejection during the formal review stage.
2.5. Regulations on Testing Exemptions
For certain product groups, such as In Vitro Diagnostic (IVD) medical devices, eligibility for testing exemption is typically linked to market authorization issued under recognized international standards, particularly the latest European regulations. Enterprises should verify whether their products qualify for testing exemption in order to prepare the dossier accordingly.
3. Notes During Submission and Dossier Processing
Even with a well-prepared dossier, enterprises must strictly comply with submission procedures to avoid cancellation:
-
Each dossier is allowed a maximum of three rounds of supplementation. If deficiencies remain after the third round, the dossier will be cancelled by the regulatory authority.
-
The maximum time allowed for dossier supplementation is 90 days from the date of notification. If the deadline is missed, the system will automatically cancel the dossier, requiring resubmission from the beginning.
Therefore, thorough pre-submission review is a decisive factor in shortening processing time and increasing the likelihood of fast-track approval.
The fast-track pathway represents a significant opportunity for enterprises to accelerate market entry for medical devices. However, to qualify for priority review, dossier standardization and consistency must be treated as top priorities. A clear, complete, and properly legalized dossier supported by reliable international certifications will substantially increase approval success rates while reducing regulatory time and costs.
For professional consultation on medical device registration, health supplements, cosmetics, and functional foods, ensuring full compliance with current regulatory requirements, please contact us via Hotline: 098 546 1894.