Vietnam: Re-submission of Medical Device Registration Applications

On 8 November 2022, Vietnam’s Ministry of Health released Decree No. 98/2021/ND-CP. This new document replaced Decree No. 36/2016/ND-CP, Decree No. 169/2018/ND-CP, and Decree No. 03/2020/ND-CP. It took effect from 1 January 2022.

MOH had been accepting applications for Market Authorization (MA) since 2017. Among these applications, some licenses were issued with an effective date of 1 January 2022, while many also remained under review. With the changes introduced in Decree 98, all unapproved applications for Class B, C, and D devices were returned for resubmission as according to the new requirements.

Product Registration for Devices

All unapproved Class B, C and D devices will be returned for resubmission, however, no additional application fee would be required for the re-submitted application. New Class B, C and D registration application must now include a Declaration of Conformity, and a clinical evaluation report as part of the technical summary. Both Class A and B applications will be issued a registration number upon immediate approval. Note that submissions for Class A and B devices can be cancelled if found to be insufficient upon post-submission review. Fast-track approval for Class C and D registration Note that under Decree 98, there are cases where Class C and D registrations are eligible for fast-track approval. Listed below are the eligible cases: a. Medical devices that have bene issued a Certificate of Free Sale (CFS) or Market Authorization by any of the following authorities:

• Food and Drug Administration (FDA) – USA

• Therapeutic Goods Administration (TGA) – Australia

• Health Cananda - Canada

• Ministry of Health, Labor and Welfare (MHLM) or Pharmaceuticals and Medical Devices Agency (PMDA) – Japan

• EU member countries, the United Kingdom, Switzerland

• National Medical Products Administration (NMPA) - China

• Ministry of Food and Drugs Safety (MFDS) – Korea

• Other countries recognized by Vietnam that grant market authorization

b. Medical devices that have already been CFS, registration licenses or import licenses*. *Import license only applies to products without a registration number.

MA License for Class C and D devices

Under the new decree, products that previously required an Import License now require Market Authorization (MA) licenses. Until 1 January 2023, Class C and D products that do not fall under these categories can be imported with just a Classification document. The products are:

• X-ray treatment equipment

• Endoscopic surgery system

• Radiotherapy equipment (Cobalt machine for cancer treatment, Linear accelerator for cancer treatment, Gamma scalpel of all kinds, Radiotherapy equipment of various kinds)

• Patient monitor

• Infusion pump, Electric injection pump

• Scalpel (high-frequency electric, laser, ultrasound)

• Surgical microscope

• System of prostate surgical equipment

• Artificial cardiopulmonary machine

• Positioning equipment in surgery

• Cold surgical equipment

• Infant incubator. Infant warmers

• Anesthesia/anesthesia machine with breathing

• Ventilation machine

• Cardiac pacemaker, pacing

• High-pressure oxygen chamber

• Extracorporeal lithotripsy system / endoscopic lithotripsy

• High intensity ultrasound equipment system for tumor treatment

• Dialysis device

• Ophthalmic surgical system (Laser Excimer, Phemtosecond Laser, Phaco, vitreous cutter, corneal flap cutter)

• Eyeglasses, contact lenses (near, far, chaotic) and contact lens storage solution

• Laser treatment machine used in ophthalmology

• Types of equipment, long-term implant materials (over 30 days) into the body

• Types of devices and materials that interfere with the body belong to cardiology, cranial neurology

• X-ray imaging devices

• Magnetic resonance system

• Ultrasound diagnostic machine

• Endoscopic diagnostic system

• Cyclotron system

• Radioactive isotope diagnostic equipment (PET, PET / CT, SPECT, SPECT / CT systems, iodine-focused iodine concentration devices I 130 , I 131 )

• Refractometer, cornea automatically

• Electrophysiological machine (EEG, ECG, electromechanical machine)

• Retinal power meter

• Meter osteoporosis

• Fundus scanners/fluorescence scanner

• Ultrasound fetal heart monitor

• Respiratory function analyzer

Advertising

In accordance to Decree 98, product registration number holders are responsible for publishing the advertising content and form on the Ministry of Health portal. Advertisement applications much include:

• Manufacturer and product information

• Registration number

• Feature/effect

• Registration holder information

• Any warnings

• Type of content

• Advertising content

Sources:

Decree 98/2021/ND-CP

Contact us at info@arqon.com for more information.

Annex

The products that require MA are:

• X-ray treatment equipment

• Endoscopic surgery system

• Radiotherapy equipment (Cobalt machine for cancer treatment, Linear accelerator for cancer treatment, Gamma scalpel of all kinds, Radiotherapy equipment of various kinds)

• Patient monitor

• Infusion pump, Electric injection pump

• Scalpel (high-frequency electric, laser, ultrasound)

• Surgical microscope

• System of prostate surgical equipment

• Artificial cardiopulmonary machine

• Positioning equipment in surgery

• Cold surgical equipment

• Infant incubator. Infant warmers

• Anesthesia/anesthesia machine with breathing

• Ventilation machine

• Cardiac pacemaker, pacing

• High-pressure oxygen chamber

• Extracorporeal lithotripsy system / endoscopic lithotripsy

• High intensity ultrasound equipment system for tumor treatment

• Dialysis device

• Ophthalmic surgical system (Laser Excimer, Phemtosecond Laser, Phaco, vitreous cutter, corneal flap cutter)

• Eyeglasses, contact lenses (near, far, chaotic) and contact lens storage solution

• Laser treatment machine used in ophthalmology

• Types of equipment, long-term implant materials (over 30 days) into the body

• Types of devices and materials that interfere with the body belong to cardiology, cranial neurology

• X-ray imaging devices

• Magnetic resonance system

• Ultrasound diagnostic machine

• Endoscopic diagnostic system

• Cyclotron system

• Radioactive isotope diagnostic equipment (PET, PET / CT, SPECT, SPECT / CT systems, iodine-focused iodine concentration devices I 130 , I 131 )

• Refractometer, cornea automatically

• Electrophysiological machine (EEG, ECG, electromechanical machine)

• Retinal power meter

• Meter osteoporosis

• Fundus scanners/fluorescence scanner

• Ultrasound fetal heart monitor

• Respiratory function analyzer