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Application procedures for medical device and veterinary drug business license

Application procedures for medical device and veterinary drug business license

As material and mental life continues to improve, people’s awareness of healthcare and protection also increasingly enhances. The mentality of “only seeking treatment when sick” is gradually being replaced by more positive habits. Therefore, a number of individuals are currently interested in venturing into the medical devices field. So, what are the requirements for obtaining a business license for medical devices and veterinary drugs? Let’s delve into more information in this article with TIN Holdings!

Besides being more proactive in examinations, treatment, and disease prevention, people are increasingly purchasing medical devices for home healthcare. Additionally, the health of pets is receiving more attention than before. To meet this new demand following current trends, more people are applying for medical device and veterinary drug business licenses to enter this sector.

Conditions and procedures for medical device and veterinary drug business license

To conduct a veterinary drug business, a storage warehouse as per regulations is required

According to legal regulations, those participating in the business of veterinary drugs and medical devices must meet the following conditions:

  • The business location for veterinary drugs and medical devices must be fixed at one address.
  • The company sign must display the business establishment’s name and the business registration board.
  • The minimum business premise area is 10m2.
  • The business premise must have the necessary means to display goods and products.
  • Sales activities must acquire complete and accurate invoices.
  • The drug preservation process must follow regulations, ensuring drugs maintain the best quality before being sold to customers.
  • For veterinary drug businesses, a storage warehouse with sufficient area and appropriate equipment and means is required.
  • For establishments dealing with vaccines, cold storage equipment and backup means for daily biological product and vaccine preservation are necessary.
  • The owner and sales staff must be certified by the competent authority as per legal regulations.
  • Note: For rapidly developing business activities by expansion with additional storage warehouses, it is required to follow the legal procedures applied for additional storage warehouses.

Application procedures for medical device business license

Medical equipment and device business is a special type of business, strictly managed and monitored by the state. Individuals and organizations applying for business in this sector must ensure the following conditions.

Conditions for medical device business


  • The individual responsible for technical aspects must achieve a university degree in engineering, medicine, pharmacy, or have been granted a certification in medical equipment specialization as per regulations.
  • The medical device business must acquire a team of engineers with sufficient qualifications in the installation, warranty, and maintenance of medical equipment and devices as per legal regulations.
  • Individuals involved in the business must be healthy and not criminally liable.

Physical facility

  • The medical equipment and device business premise must acquire a suitable storage warehouse and meet the operational conditions as per regulations.
  • The business must acquire all necessary technical equipment and tools to ensure the installation and warranty process of medical equipment and devices.
  • Additionally, the business must be fully equipped with fire prevention devices and ensure environmental hygiene.


To be legally granted a medical device business license, the enterprise must acquire all medical equipment and devices approved by the Ministry of Health.

Conditions for clinic business license

The operation and granting of clinic business licenses are strictly managed and monitored. Individuals and organizations must meet the following requirements:

  • Be granted a business registration certificate with the business field of clinics or company establishment decision by the competent authorities as per legal regulations.
  • Be granted an operational business license for the clinic by the Minister of Health as per legal regulations.

Regulations for issuance of business registration certificate of clinic are as follows:

  • Be granted an operation license by the provincial or city Department of Health.
  • Be granted a Business Registration Certificate by the Department of Planning and Investment for the clinic.

Application procedures for Veterinary Drug Business License

Facilities for veterinary examination and drug business must comply with legal regulations

Step 1: Prepare the application for veterinary drug business, including:

  • An application for veterinary drug business inspection.
  • A report on the veterinary drug business conditions.
  • A copy of the business registration certificate.
  • A certificate of veterinary drug business practice.

Step 2: Submit the dossier

After preparing the dossier as mentioned above, the business owner submits the dossier to the local Veterinary Bureau for review and issuance of the veterinary drug business license.

The above shares from TinLaw cover the application procedures for medical device, veterinary drug business license, and clinic operation. Call us at 0919 824 239 if you have any questions during the company registration process.