Medical Equipment Classification Advisory Letter
QUICK AND ACCURATE MEDICAL EQUIPMENT CLASSIFICATION CONSULTING SERVICE
Based on Decree 98/2021/ND-CP on medical equipment management , 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, B, and register a circulation number for medical equipment of type C, D in Vietnam.
Decree 98 was issued with outstanding new points, including changes in the classification of medical equipment, shifting from the classification of medical equipment by an organization licensed to be qualified to classify medical equipment to Classification of medical equipment will be performed and supervised by the owner of the medical equipment circulation number.Decree 98 takes effect from date 01/01/2022.
This change will certainly cause many difficulties and confusion for businesses in this initial stage. With With 5 years of experience in classification and a team of highly specialized lawyers and doctors, MedNovum is proud to be a professional medical equipment classification consulting unit, ready to accompany and support businesses in their difficulties when classifying medical equipment.
Risks of choosing an unreliable medical equipment classification consulting unit
– Late progress: The unit does not return the classification consultation results on time as expected, affecting the import and circulation progress.
– Encountering risks when the Ministry of Health discovers misclassification during post-audit as:
- Affecting the procedure for registration of circulation numbers (for medical equipment of type C, D) or announcement of applicable standards (for medical equipment of type A, B);
- Affecting the financial security and reputation of the business;
- Administrative sanctions;
- Withdrawal of medical equipment declaration/circulation number;
- Recall all medical equipment currently in circulation on the market;
- Re-do the procedure for declaring applicable standards or registering circulation numbers according to new classification.
MedNovum – A reputable and professional medical equipment classification consulting company
MedNovum is confident that it will be a partner with businesses in successfully approaching the potential medical equipment market in Vietnam. Because:
- Team of experts: Our staff are lawyers, doctors, pharmacists with expertise, knowledge of the law, and many years of experience in the field of medical equipment.
- All personnel involved in the medical equipment classification process have Medical Equipment Classification Certificate.
- MedNovum acquired Professional liability insurance for medical equipment classification work from 2019.
- Partner of the world's leading medical equipment companies such as: Medtronic, Fujifilm, Waters Corporation, Delcon SRL, Hans Biomed, Beckman Coulter,...
- Fast time to return classification consultation results only 1 – 4 days work
- Commitment to accuracy of the classification advice results.
- Cost optimization for the following procedures to classify risks by cluster, family, and medical equipment group solutions appropriately according to the business situation of each enterprise
- Many medical equipment classification consulting service packages with costs suitable to the needs of each business.
- Consulting, supporting, providing information on legal corridors related to the following procedures after classification: applying for import licenses, declaring standards (for medical equipment of types A, B) or registering circulation numbers (for medical equipment of types C, D)
What documents do businesses need to prepare to classify medical equipment?
– Document requesting consultation on medical equipment classification
– 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 consulting on medical equipment classification at MedNovum
MedNovum proceeds through 8 steps with 8 personnel 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 medical equipment classification.
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: Fill in the classification consultation 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: Send to customer
After completing the medical equipment classification consultation, MedNovum will send a hard copy to the customer.
♦ Customers can use the service fast Premium return results within 1 – 4 working days or Slow Basic return results within 5 – 7 working days.
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