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MPD FAQs

Plant Section

  1. Human Allopathic Medicine;
  2. Veterinary Allopathic Medicines;
  3. Traditional Medicines;
  4. Blood and Blood products;
  5. Supplements;
  6. Medical Devices; and
  7. Medical Gases.
If you are importing medical products for sale & distribution in the country, you will have to register and apply for Import authorization. However, registration is not required in following cases:
  1. If you are bringing medical products for personal use accompanied by a valid medical prescription.
  2. Non-prescription medicines for personal use (the list is published on authority’s website at www.bfda.gov.bt) the quantity of which is less than one month dose.
  3. Medical devices not notified by the Authority

To register medical products, first a local dealer (called Market Authorization Holder) or manufacturer should apply for Technical Authorization for Sale and Distribution from the BFDA based on which Trade License will be issued by the Department of Trade, Ministry of Industry, Commerce and Employment. After obtaining the Trade License and Technical Authorization for sale and distribution, a local dealer can submit documents related to medical products to the BFDA for registration. The documents required for registration of medical products can be viewed from Guideline for registration of Medicinal Products 2020 and Addendum 2021: Addendum for registration of Medicinal Products 2020.

To register medical device, please follow the procedures given below:
  1. Check the latest notified list of medical devices issued by BFDA on its official website under the notifications section for the latest update. Current: Medical Device List.
  2. If your product requires registration with the BFDA, register your firm as per the requirements set in the notification Notification on Medical Devices.
  3. Before Registration of your firm ensure that you have a registered competent person for both wholesale and retail. The qualification for the competent person is also mentioned in the notification Notification on Medical Devices. 
  4. Register medical devices as per the requirements set in the Guidelines for Registration of Medical Devices, 2022.
 
If all the required documents are submitted during the time of application, a medical product can be registered within 2-3 months.
An initial application fee of BTN 500/- per product is levied. Once the assessment of the document is completed, a registration fee of BTN 1500/- per product will be charged. The fees may be however revised from time to time.
Once registered, the registration status of the product is valid for a period of three years. After the expiry of validity of three years, you can apply for renewal of registration. Fees and charges remain the same as initial registration.

You can access this web-link for more information : Guideline for registration of Medicinal Products 2020 and Guidelines for Registration of Medical Devices, 2022.

A Competent Person is a person who is registered with the BFDA based on:

  1. qualification and practical experience (as per the Bhutan Medicines Rules and Regulation 2019); and
  2. successful passing of the competency exam conducted by the BFDA (for pharmaceuticals).

The Competent Person will supervise manufacturing, sale and distribution of medical products including medical gases.

If you are a Pharmacist/Pharmacy Technician/Medical Doctor/Veterinary Doctor/Drungtsho (Traditional Medicine Physician) or if you possess a Diploma in gSso-ba Rig-pa medicine or diploma in any field with minimum of three years experience in medical device (for medical device) you can apply for registration as a Competent Person via g2c services/in-person. You will be asked to pay a fee of BTN 300/- as an application fee and will be assigned a date for examination. If you pass the theory and practical exams, you will be issued a certificate of Competent Person.
To open a pharmacy, you should fulfill following requirements:
  1. Competent Person certified by the BFDA
  2. Have a suitable location separated from meat shops/living rooms etc.
  3. Apply to the BFDA for Technical Authorization for Sale & Distribution of Medical Products Government to Citizen (G2C) portal.
  4. BFDA will visit & inspect your location and you will be issued a Technical Authorization.
  5. Proceed to obtain Trade License.
  6. You are ready to stock/sell registered medical products.
All medical supplies for public health services in Bhutan are centrally procured and distributed through the Department of Medical Products under National Medical Services.
Supplements are products intended to supplement the diet for both humans and animals. They are not medicines and, therefore, are not intended to treat, diagnose, mitigate, prevent, or cure diseases. Supplements are also known by different names such as dietary supplement, nutrition supplement, nutraceuticals, complementary medicines etc.
Currently, the MPD under the BFDA controls the sale and distribution of supplements. Once an application for listing supplement is received, the MPD follows a risk-based approach and will be listed under either of the following categories based on ingredient and label claim/ingredient.
  1. Nutrition/General Claim Products for both health and feed supplements;
  2. Functional Products for both health and feed supplements; and 
  3. Disease Risk Reduction Product for health supplements.

Supplements with claims for nutritional support and general maintenance are classified as Nutrient/General Claim Product. This category of supplements can be sold either from general shops or licensed pharmacies. However, applicants are required to apply for a listing of supplements using the Supplement submission form. Subsequently, Import Authorization (IA) should be obtained from the MPD, BFDA to import, sell and distribute supplements.

Supplements with claims which relate to a positive contribution to health or to the improvement of a function or to modifying or preserving health in the context of the total diet on normal function or biological activities of the body or maintains or enhances structure or function of the body, excluding disease related claims are classified as Functional Claim Product.

Examples of such claims include: maintains healthy joints, promotes healthy skin etc.

This category of supplements should be sold only from the licensed Pharmacy. Thus, the applicant should have Technical Authorization for Sale & Distribution (TA) obtained from the MPD prior to obtaining a listing certificate. Applicants are required to apply for listing of supplements using the Supplement submission form. Subsequently, IA should be obtained from the MPD to import, sale and distribute Health Supplements.

Supplements with claims of significantly altering or reducing a risk factor of a disease or health related condition are classified as disease risk reduction products.

Examples include, reducing the risk of osteoporosis.

This category of supplements should be sold only from the licensed Pharmacy. Thus, the applicant should have Technical Authorization for Sale & Distribution (TA) obtained from the MPD prior to obtaining a listing certificate. Applicants are required to apply for listing of supplements using the Supplement submission form. Subsequently, IA should be obtained from the MPD to import, sell and distribute Health Supplements.

Supplements are not allowed to claim benefit, cure/treatment of any of the above disease conditions. More information on the list of prohibited diseases/conditions can be obtained by List of Prohibited Diseases. Products with prohibited claims will not be listed/granted import authorization.

Yes. If the product contains prohibited ingredients, the supplement will not be allowed in the interest of public safety. Some examples of prohibited ingredients include stem and bark extracts of the popular fruit pomegranate. Please refer to the 

Guideline for Regulating Supplements for more information.

You are required to obtain Provisional Authorization for Manufacture from the MPD under the  BFDA before the final authorization to manufacture. Your firm should fulfill all the regulatory requirements as per the current Good Manufacturing Practice (GMP).

Currently, Medical Product Division (MPD) provides the 19 services and refer to the Service Delivery Standard for MPD for more details.

You can email to the following address or call the Medical Product Division during office hours at the following:

  1. E-Mail: mpd@bfda.gov.bt 
  2. Telephone No: +975-2-339015
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