Brunei Medical Device Regulation

Ministry of Health - Registration Medical Product

https://www.moh.gov.bn/SitePages/Registration%20Medical%20Product.aspx

- Brunei Medical Board - Brunei Nursing Board ... In Brunei Darussalam, the importation, manufacture and sale of medicinal and supply products is regulated under: Medicines Order, 2007; Medicines (Labelling) Regulations, 2010; Medicines (Licensing, Standard …

Ministry of Health - Acts and Regulations

https://www.moh.gov.bn/SitePages/Acts%20and%20Regulations.aspx

An Act to provide for the regulation and control of midwifery in Brunei Darussalam, the registration of midwives and all matters ancillary thereto. 3: Medical Practitioners and …

Brunei - Medical Equipment - International Trade …

https://www.trade.gov/country-commercial-guides/brunei-medical-equipment

Guidelines - moh.gov.bn

https://www.moh.gov.bn/SitePages/Guidelines.aspx

Guide to Application for Registration of Medicinal Products. updated - 3rd Edition. Guidelines for Notification of Cosmetic Products in Brunei Darussalam. Guide to Application for an …

ASEAN Medical Device Regulatory Integration

https://www.pacificbridgemedical.com/publication/asean-medical-device-regulatory-integration/

The ASEAN committee responsible for harmonization of Southeast Asia medical device regulation is the Medical Device Product Working Group (MDPWG). …

Medical device registration in Brunei - Elsmar Cove Quality and ...

https://elsmar.com/elsmarqualityforum/threads/medical-device-registration-in-brunei.67971/

Adding unclassified product to the medical device registration. US Food and Drug Administration (FDA) 1. Dec 11, 2020. Y. Possibility for Medical Device registration …

Ministry of Health - Brunei Medical Board

https://www.moh.gov.bn/SitePages/Brunei%20Medical%20Board.aspx

Brunei Medical Board 2G4:02, Level 4, Block 2G, Ong Sum Ping Condominium, Jalan Ong Sum Ping, Ministry of Health Bandar Seri Begawan BA1311, Brunei Darussalam. E-mail: …

List of Countries without Formal Regulatory Approval …

https://www.regdesk.co/countries-no-medical-device-regulations/

Learn more about the countries around the world that have no medical device regulations which can be benefitical for smaller companies. ... “Brunei”. Tuv-sud.com. N.p., 2016. Web. 27 Dec. 2016. …

Brunei - Global Market Access | TÜV SÜD - Tuv Sud

https://www.tuvsud.com/en/services/global-market-access/brunei

Regulations. All telecommunication, radio communication and satellite equipment to be sold and used in Brunei Darussalam must be type approved by AITI. Type approval must be …

Brunei Medical Device Regulation | Day of Difference

https://dayofdifference.org.au/b-medical/brunei-medical-device-regulation.html

In 2015, the ASEAN Medical Device Directive (AMDD) agreement was signed in by all the 10 ASEAN countries – Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, …