Medical Device Registration in Vietnam

Introduction to Vietnam Medical Device Regulation

This article deals with the Vietnam medical device regulation. The Ministry of Health (MOH) governs the registration and approval of all Medical Devices in Vietnam along with the Department of Medical Equipment and Health Works (DMEHW). The Southeast Asian Nations which consist of 10 countries and health care being the highest priority of all, the authorities help in taking care of all the trade barriers. The AHWP, (Asian Harmonization Working Party), APEC(Asia Pacific Economic Cooperation) and ASEAN (Association of South East Nations) are the authorities which govern the overall regulations for all the 10 countries such as – Thailand, Indonesia, Malaysia, the Philippines, Singapore, Brunei, Vietnam, Laos, Myanmar and Cambodia. Registering all the Medical Devices in Vietnam is mandatory before they are sold and distributed in the country. In 2016 the MOH released Decrees 36 & 39 which states that  DMEHW is in charge of all medical device registration in Vietnam. 

Appointing a Local Agent for Medical Device Registration in Vietnam:

The first step towards Regulatory Compliance is by appointing a Local Agent. They handle the assessment for all the Medical Devices and the registration and importation of the Medical Devices into the Country. 

Medical Device Classification and Approvals Needed for Medical Device Importation in Vietnam

All approval from the country of origin, including CE Mark certificate and U.S. FDA approval, must all be submitted. For all Class A Medical Device products, the application can be submitted along with the administrative documents, such as Letter of Authorisation and Certificate of Free Sales has to be submitted either in Vietnamese or in English language. All Licenses issued for Class A, are valid indefinitely. For Class B, C and D, to get the Market Authorization License, the manufacturer needs to submit the Technical data demonstrating the device conformity assessment to the ASEAN MDD which is in a common Dossier Submission Template (CDST) format along with a Quality Management System complying with ISO 13485:2016. The MA license is issued and it has a validity of 5 years.

The documents required for Class A Device Registration under the standard medical device classification structure are given below

• Application form

• Classification table of registered device

• Declaration of Class A application

• Quality control standards certificate

• Authorization letter by device’s owner

• Conformity certificate

• Eligibility certificate for warranty

• Written instructions for device

• Free sales certificate

• Device label

Class B, C & D Device updates follow strict medical device classification rules. In addition to the above mentioned documents, manufacturers will also need to submit the below given documents:

• Manual with device specifications, functions and technical information

• Device description in brief

• Clinical testing data summary (Class C and Class D only)

• Certificate of Inspection (Class C and Class D only)

Essential Documents for Medical Device Importation in Vietnam

Once the approval is obtained, the manufacturer can import into the Country. The following documents are needed for the Importation of the Medical Devices under current Vietnam medical device regulation protocols

• A written request for the issue of Form No.01

• Valid Certificate of Free Sales Certificate

• ISO Certification

• The Valid Letter of Authorization as per Form specified in Annex III

• The Technical Material in Vietnamese language (Form No. IV)

• Catalogue Describing the Functions

• Technical Parameters

• The Clinical Assessment

• Manufacturers or the Owner should submit Medical Equipment Manual and Details of the Material 

• As Specified in section 49 of Annex I, issued in the Circular.

• According to article 10 of Circular 30/2015/TT BYT.

• Equipment import Permit and the List of other countries in which this Device is approved and its Safety Information

Medical Device Regulation Vietnam: Circulation Registration Changes

This Article deals with the new Decree Released by the Vietnam Medical Device Registration on March 4, 2023. The Deputy Prime Minister Tran Hong Ha signed Decree No. 07/2023/ND CP. This amendment’s goal is to correct flaws, restrictions, and limitations that have emerged in the past while satisfying standards for management procedures and integration in the medical equipment industry.

The Medical equipment circulation registration numbers and licenses to import biological in vitro diagnostic products issued by Vietnam Medical Device Registration between January 1, 2018, to December 31, 2021 may be applied until the end of December 31, 2024.

Change Management and Pricing Disclosure for Medical Device Regulation Vietnam

Public health institutions are changing their procurement and bidding procedures to solve problems with determining the timing of purchases and sales that result from the following.

1. The timing of creating procurement estimates, strategies for choosing contractors

2. Contract negotiations during the bidding process

3. The timing of approval of the contractor selection process

4. The time of signing the sale contract and the date of delivery.

Regulations governing the import, export, temporary import and re export of medical equipment should be updated under the medical device regulation Vietnam framework. The government has recommended enacting a resolution to test out policies and practices that will ensure that medical equipment, supplies and the costs of tests and treatments are all covered by health insurance in line with the particular conditions of the business. Health care occurs before the necessary regulatory papers are published.

Medical Devices to Be Regulated Independently in this Country?

In most Asian countries including South Korea, Indonesia, Thailand, Malaysia, Philippines, Singapore and Vietnam medical devices are regulated separately from drugs. However, in India currently medical devices, drugs, IVDs and cosmetics are all regulated under the same Drugs and Cosmetics Act. The new government under Modi is keen on delinking the medical device industry from the pharmaceutical sector to encourage R&D, manufacturing, exports, FDI into the country.

The Ministry is expected to shortly seek public opinion and comments through the website of CDSCO, the national regulatory body for the domestic pharma and medical devices. It will then issue a notification for change in the drug rules through the Law Ministry to carry out the delinking.

India to Make these Changes to Encourage Export of Medical Devices

The South East Asia Medical Device markets including Korea, Indonesia, Thailand, Malaysia, India, Philippines, Singapore, Malaysia and Vietnam have been growing at a higher rate than the developed medical device markets of the Western world. These countries have shown a high rate of imports in medical devices, larger expenditure by the private and government sectors and increasing interest in medical device manufacturing. Demands for import and infrastructure in the medical device market in South Korea, Indonesia, Thailand, Malaysia, India, Philippines, Singapore, Malaysia and Vietnam is mainly due to the expansion in the healthcare sectors and increasing priority of the governments to provide high quality of care to its people.

The Indian medical device industry is also primarily run on imports. About 85% of medical devices are imported into the country. In order to address this issue, the Indian Ministry of Health and Family Welfare (MOHFW) and the Central Drugs Standard Control Organization (CDSCO) conducted a series of meetings to understand the challenges for medical device manufacturers in India and how best to address them. Discussions included the registration of medical devices, IVDs, cosmetics and drugs in India.

Key points discussed include:

• Re visiting and implementing the Schedule MIII, which is the draft guidance on good manufacturing practices and facility requirements

• Systems for export labeling

• Clarification for clinical evaluation and adverse reporting

• Free Sale Certificate: Manufacturers often require this certificate to export medical devices . It has been agreed that the state licensing authorities extend the Free Sale Certificate validity from 2 years to 5 years to allow manufacturers to export.

• Online Database: to make the list of companies howling export licenses easily accessible by different regulatory authorities worldwide.

Conclusion

The registration of medical devices in Vietnam is an organized process governed by the Ministry of Health and the Department of Medical Equipment and Health Works, involving obligatory regulations related to the designation of a local representative, dossier submission, and approvals. For Class A devices, there are simpler procedures involving the acquisition of licenses, whereas Class B, C, and D devices must meet ASEAN MDD technical dossier criteria, ISO 13485 certificates, and five year licenses. The importation requires extensive documentation including Free Sales Certificates and clinical data. The new decrees in Decree No. 07/2023/ND CP make changes to the circulation licenses and rectify inefficiencies in the regulatory process. As Vietnam harmonizes its regulations with ASEAN, the prospects are excellent for expansion into the market.

Vietnam Medical Device Registration and Equipment Circulation Support

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