MEDICAL EQUIPMENT CLASSIFICATION SERVICE

 

Based on Decree 36/2016/ND-CP on medical equipment management and Decree No. 169/2018/ND-CP, Decree No. 03/2020/ND-CP Amending and supplementing a number of articles of Decree 36/2016/ND-CP, businesses need to carry out medical equipment classification procedures. If you want to apply for an import license, declare applicable standards for medical equipment of type A, register a circulation number for medical equipment of type B, C, D in Vietnam.

The results of this risk classification are only recognized when performed by a licensed entity qualified to classify medical devices (MTDs).

 

 

Risks of choosing an unreliable medical equipment classification unit

– Late progress: The unit does not return the classification results on time as expected, affecting the progress of import and circulation.

– Encountering risks when the Ministry of Health discovers misclassification during post-audit as:

• Impact on procedures for applying for import license and circulation number (for medical equipment of type B, C, D) or announcement of applicable standards (for medical equipment of type A)
• Impact on financial security and reputation of the business
• Administrative sanctions
• Withdrawal of medical equipment declaration/circulation number
• Recall all medical equipment in circulation on the market
• Re-do the procedure of declaring applicable standards or registering circulation numbers according to new classification

MedNovum – A reputable medical equipment classification company, licensed by the Ministry of Health

MedNovum is a licensed entity qualified to classify medical equipment. MedNovum is confident that it will be a partner to accompany businesses in successfully accessing the potential medical equipment market in Vietnam. Because:

• Our staff are lawyers, doctors, pharmacists with expertise, knowledge of the law, and many years of experience in the field of medical equipment.
• Partner of the world's leading medical equipment companies such as: Emergo, Medtronic, Fujifilm,...
• Fast sorting time only 1 – 4 business days.
• Commitment to the accuracy of classification results.
• Optimize costs for post-risk classification procedures using cluster, family, and medical equipment group solutions appropriately according to the business situation of each enterprise.
• Many medical equipment classification service packages with costs suitable to the needs of each business.
• Consulting, supporting, providing information on legal corridors related to post-classification procedures: applying for import licenses, declaring standards (for medical equipment with type A medical equipment) or registering circulation numbers (for medical equipment with types B, C, D).

What documents do businesses need to prepare to classify medical equipment?

– Document requesting to issue a medical equipment classification certificate;

– Product catalog (Original product catalog in English);

– Document describing medical equipment technical specifications in Vietnamese according to the form (According to the form in Decree 36/2016/ND-CP);

– ISO 13485: 2016 of medical equipment manufacturing unit;

– Certificate of Free Sales (CFS);

– Certified copy of business registration;

– Instructions for use of medical equipment.

Procedure for classifying medical equipment at MedNovum

MedNovum proceeds through 8 steps with 8 staff in charge of each stage, ensuring independence and aiming to improve accuracy. MedNovum would like to share the detailed process as follows:

Step 1: Receiving documents

Receive and check documents according to the list of documents required for classification of Medical Equipment.

Step 2: Classification 1

Classifier (1) proceeds to read the records and classify them according to regulations.

Step 3: Classification 2

Classifier (2) proceeds to read the records and classify them according to regulations. (Classification is independent of classifier 1).

Step 4: Create a classification form

Conduct product name/model/code checks according to customer requirements and conduct draft classification based on the consensus results of the previous 2 classification specialists.

Step 5: Legal check

The compliance officer checks the legality of the classification according to the law.

Step 6: Check & Sign Confirmation of Expertise

A certified classifier conducts a final inspection and signs the classification.

Step 7: Director approval

Attorney/director proceeds with approval.

Step 8: Publish results & Send to customers

Publish the results of medical equipment classification and records on the Ministry of Health's Information Portal. Send hard copies to customers.

 

♦ Customers can use the service fast Premium return results within 1 – 4 working days or Slow Basic return results within 5 – 7 working days.

 

 

>> See more legal services at MedNovum:

– Registering medical equipment circulation number

– Apply for a license to import medical equipment

– Announcement of eligibility to buy, sell and produce medical equipment

– Translation and compilation of technical documents on instructions for using medical equipment