Application for registration of circulation of CD-type medical equipment

Article overview

Registration for circulation of CD-type medical equipment brings many important benefits to businesses. Registering for the above procedures will help customers comply with regulations, avoid legal risks and protect consumer rights. At the same time, the product being granted a circulation number from the Ministry of Health will enhance its reputation and create trust with customers and partners. In the following article, Long Phan will analyze in detail each case of registration documents for circulation of CD-type medical equipment.

Application for registration of circulation of CD-type medical equipment
Application for registration of circulation of CD-type medical equipment

What are Class C and D medical devices?

According to Article 4 of Decree 98/2021/ND-CP, medical devices are classified into 4 groups based on the level of risk, from low to high:

  • Class A: Low-risk medical device.
  • Class B: Medical devices with medium-low risk.
  • Class C: Medical device with medium-high risk level.
  • Class D: Medical devices with a high level of risk.

Class C and D equipment requires stricter inspection and licensing processes due to potential risks related to user safety and health. Registering for circulation of CD-type medical equipment not only complies with the law but also meets technical standards so that the product can be legally distributed on the market.

What is CD-type medical equipment?
What is CD-type medical equipment?

Application for registration of circulation of CD-type medical equipment

Circulation registration dossiers for CD-type medical equipment are regulated differently depending on the technical nature, purpose of use and case of issuance of circulation number. Pursuant to regulations on registration dossiers for circulation of CD-type medical equipment specified in Article 30 of Decree 98/2021/ND-CP include:

Application for new circulation number for medical equipment with national technical regulations

In the case of CD-type medical equipment with corresponding national technical regulations, the registration documents for circulation are specified in Clause 1, Article 30 of Decree 98/2021/ND-CP, including:

  • Document requesting issuance of new circulation number.
  • Certificate of ISO 13485 compliance is still valid at the time of application submission.
  • Power of attorney from the equipment owner to the circulation registration facility (if any).
  • Warranty confirmation from the owner, except for equipment that is used once or does not have a warranty.
  • Valid circulation certificate for imported medical equipment.
  • General technical dossier (CSDT dossier) according to ASEAN regulations.
  • Certificate of conformity.

This process ensures that the equipment meets safety standards and complies with national technical regulations, creating favorable conditions for circulation.

Applications for issuance of new circulation numbers for medical equipment that are measuring instruments must have sample approval according to the provisions of law on measurement

For type C and D  medical devices belonging to the group of measuring instruments, registration documents are specified in Clause 1, Article 30 of Decree 98/2021/ND-CP. Accordingly, the registration dossier includes:

  • Document requesting a new circulation number.
  • Decision to approve samples of medical equipment according to the law on measurement.
  • Certificate of ISO 13485 compliance, valid at the time of application.
  • Power of attorney from the owner of the medical equipment to the facility performing registration for circulation, still valid at the time of application submission (except for the case specified in Point a, Clause 1, Article 25 of this Decree).
  • Certificate of warranty eligibility issued by the owner, except in the case of single-use medical equipment or documents proving no warranty.
  • The circulation certificate is still valid at the time of application submission for imported medical equipment.
  • General technical dossier on medical equipment according to ASEAN regulations (CSDT dossier).

This record helps ensure that measuring devices meet accurate standards, without affecting user safety and health.

Application for quick issue of circulation number

In case of quick issuance of circulation numbers for medical equipment of type C and D, it applies to some special cases according to Article 29 of Decree 98/2021/ND-CP. Accordingly, licensing documents are specified in Clause 3, Article 30 of Decree 98/2021/ND-CP, as follows:

  • Document requesting a new circulation number.
  • Certificate of ISO 13485 compliance is still valid at the time of application.
  • Power of attorney from the equipment owner to the circulation registration facility (if any).
  • Warranty confirmation from the owner, except for equipment that is used once or does not have a warranty.
  • Certificate of circulation issued by one of the reference countries (according to Point a, Clause 2, Article 29).
  • Certificate of circulation for imported medical equipment along with Import License or Circulation Number (according to Point b, Clause 2, Article 29).
  • Quality assessment certificate issued by Vietnamese competent authorities for in vitro diagnostic medical equipment (except in cases where it is granted a certificate of free circulation or a certificate of circulation from reference countries).
  • CSDT profile (general technical profile).

The expedited issuance process is often applied to equipment with similarities in international standards, facilitating quick circulation and minimizing waiting time.

Application for issuance of new circulation number in case of emergency

For type C and D medical equipment that needs to be circulated quickly due to urgent needs, registration documents are specified in Clause 4, Article 30 of Decree 98/2021/ND-CP. Profile includes:

  • Document requesting a new circulation number.
  • Documents as prescribed in Points b, c and d, Clause 1 of this Article, include:
  • ISO 13485 certificate is still valid.
  • Power of attorney from the owner of the medical equipment to the establishment registering for circulation.
  • Certificate of warranty eligibility issued by the owner.
  • Circulation certificate or emergency use permit for imported medical equipment.
  • Technology transfer contract for the cases specified in Point dd Clause 3 Article 29 of the Decree.
  • Processing contract for the cases specified in Point e, Clause 3, Article 29 of the Decree.
  • Certificate of product quality inspection or evaluation from one of the recognized units
  • CSDT profile (general technical profile).

This process is flexibly applied to medical equipment serving in emergency situations such as pandemics, when demand is high and urgent.

Application for issuance of circulation numbers for other types of equipment

For devices not included in the above cases, the required circulation registration documents are specified in Clause 5, Article 30 of Decree 98/2021/ND-CP, as follows:

  1. Document requesting a new circulation number.
  2. ISO 13485 certificate is still valid.
  3. Power of attorney from the owner of the medical equipment to the establishment registering for circulation.
  4. Certificate of warranty eligibility issued by the owner.
  5. Product quality assessment certificate or CSDT file (general technical file).
  6. The results of appraisal of the medical records of the unit designated by the Minister of Health are enclosed with the medical records.
  7. Quality certificates issued by competent Vietnamese agencies for in vitro diagnostic medical equipment that are reagents, calibrators, and control materials.
  8. Testing and testing certificates for chemicals and disinfectant preparations for medical equipment, including:
  • Test report of ingredients and content of active disinfectant substances from a licensed unit.
  • The test form evaluates the biological effectiveness and side effects of the product for test participants, from a unit qualified to conduct testing according to legal regulations on chemicals and preparations.

This application is suitable for equipment that does not require expedited approval and meets the usual standard requirements.

Service of registration for circulation of CD-type medical equipment
Service of registration for circulation of CD-type medical equipment

Consulting services on registration documents for circulation of CD-type medical equipment in Long Phan

With a team of consultants with many years of experience in solving issues and licensing procedures, Long Phan provides support services for registration of circulation of type C medical equipment, D professionally and effectively. Services include:

  • Consulting on regulations on procedures and procedures for licensing and registration of circulation of medical equipment.
  • Assist customers in collecting and preparing necessary documents, according to regulations.
  • Representing customers to submit applications and work at competent agencies.
  • Check and review the registration dossier to ensure all information and documents are complete and accurate.
  • Advise on how to edit and supplement documents if the documents do not meet the requirements.
  • Monitor the approval process and assist in handling issues that arise during the application appraisal process.
  • Support consulting to resolve when disputes occur.

Registering for circulation of CD-type medical equipment is an important process and requires strict compliance with regulations in Vietnam. With a team of experienced experts and a deep understanding of regulations in the field of applying for medical licenses, Long Phan will support customers quickly and effectively. Please contact us via hotline 0906735386 for timely support.