Strategic Regulatory Partner for Success in Vietnam

  • Tailored Regulatory Support
  • Product Maintenance & Compliance
  • Flexible Regulatory Teams

Greetings from
Freyr Vietnam

The increasing demands for quality healthcare and the rapidly emerging economic sector presents Vietnam as a beneficial market for foreign Drug or Device manufacturers. All medicinal products to be imported into the region requires approval from the Ministry of Health (MOH) and the Drug Administration of Vietnam (DAV) while medical devices are regulated by the Department of Medical Equipment and Health Works (DMEHW). Communicating with different internal regulatory bodies might pose a challenge for foreign manufacturers who are new to Vietnamese Regulatory system.

Freyr, as a global regulatory partner, assists foreign manufacturers in interpreting the Vietnamese regulations and advises them on Regulatory strategies to be implemented for the region for compliant market authorizations. With streamlined and quicker submission procedures, Freyr provides Regulatory consulting services in Vietnam for:

Industries We Serve in Vietnam

Vietnam’s Medical Device market is picking up and is currently one of the booming sectors in the country. Medical Devices in the country are regulated by the Department of Medical Equipment and Health Works (DMEHW) under the Ministry of Health. Foreign manufacturers must appoint a Vietnam Local Authorized Representative to assist them in Vietnam medical device registration process.

Cosmetics play an important role in enhancing one’s inherent beauty and physical features. The increase in consciousness regarding personal appearance among individuals is driving the growth of the cosmetic Industry. The aging population and rapid urbanization across Vietnam are fostering the growth of the cosmetics market. Also, the surge in cosmetic spending is the resurgence of natural products, along with changing consumers’ preferences towards products made with natural ingredients. The growing demand for natural products is estimated to fuel the Vietnam cosmetic market, leading to the need for Vietnam cosmetic registration.

Food products in Vietnam are mainly regulated and managed by three (03) different ministries, the Vietnam Ministry of Health (MOH), the Ministry of Agriculture and Rural Development (MARD), and the Ministry of Industry and Trade (MOIT). Decree No. 38/2012/ND-CP- provides guidance to MARD, MOIT, and MOH with regard to implementing provisions of the Laws of Food Safety (LoFS). Health supplements may be produced in the form of soft gels, pellets, tablets, granules, powder, liquid, and other small dosage forms, which are further divided into smaller doses.

Freyr Offerings

  • Strategic Regulatory affairs consulting
  • Regulatory intelligence
  • Registration pathways and license management services
  • Dossier preparation, review and management
  • Regulatory Labeling
  • Obtaining approvals for labeling, advertising

Freyr Advantages

  • Strategic local Health Authority contacts - with DAV and VFA
  • Expert Regulatory team with proven expertise and experience
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislations and Regulatory guidelines 

Looking for Regulatory Support in Vietnam

Contact us now for Expert Guidance and Support