consulting on vietnam medical device classification
According to Decree 98/2021/ND-CP on medical devices management, medical device classification is an important procedure to circulate, import, distribute medical devices within the territory of Vietnam. Government defined that medical devices shall be classified into 4 classes:
- Class A medical devices which is medical devices with low level of risks.
- Class B medical devices are medical devices with lower average level of risks;
- Class C medical devices are medical devices with upper average level of risks;
- Class D medical devices are medical devices with high level of risks.
For class A, B medical devices, organizations shall provide medical device classification result and the number of the certification of declaration of applied standards when importing medical devices.
For class C, D medical devices, organizations shall provide medical devices classification result and the number of the certificate of registration to implement custom clearance works.
Risks when choosing an unreputable medical device classification consultant
Slow progress: The unit returns the classification consulting results later then the expected time that affects the import and circulation schedule.
There are risks when the Ministry of Health discovers misclassification in the post-inspection process, such as:
+ Affects import license and registration of medical devices (for medical equipment of types C, D) or declaration of applied standards (for medical equipment of types A, B)
+ Affecting the financial safety and reputation of the business
+ Administrative sanction
+ Revoking the number of the certificate of declaration/registration
+ Revoking all medical devices circulating on the market
+ Redo the procedures for declaration of applied standards or registration of medical devices according to the new classification.
MedNovum – A reputable and professional Vietnam medical device classification consulting unit
With 5 years of experience in classifying a variety of medical equipment for companies, MedNovum is confident to be partner with businesses in successfully accessing the potential market of medical equipment in Vietnam. By:
- Our team is lawyers, doctors, pharmacists that have expertise, knowledge of the law, many years of experience in the field of medical devices.
- Be a partner of the world’s leading medical devices companies such as: Medtronic, Fujifilm, Waters Corporation, Delcon SRL, Hans Biomed, Beckman Coulter, Stryker, Streck,…
- MedNovum is the unique – specialized unit and provides full legal services for medical equipment in Vietnam.
- Returning the result of medical devices classification consultancy quickly, only from 1 – 4 working days.
- Commitment to the accuracy of medical devices classification consulting result.
- Optimizing costs for procedure after classify medical device in Vietnam by grouping reasonably Cluster, Family, Ministry of medical devices according to the business situation of each organization.
- Many medical device classification consulting packages for a cost in line with demands of your business.
- Consulting, supporting and providing information on the legal corridor related to the procedures after classifying medical devices in Vietnam: applying for an import license, publicizeapplied standards (for medical devices of types A, B) or register a circulation number (for medical devices of types C, D).
The Vietnam medical device classification consulting process at MedNovum
MedNovum goes through 8 steps with 8 people in charge of each step, ensuring independence and improving accuracy. MedNovum would like to share the detailed process as follows:
Step 1: Receive dossiers
Receive and check dossiers according to the list of medical device classification request dossiers
Step 2: 1st classify
Classifier (1) conducts reading and classifying according to regulations.
Step 3: 2nd classify
Classifier (2) conducts reading and classifying according to regulations. (Classify independently with classifier 1)
Step 4: Do the classification consultation form
Check name/model/code of medical device at the request of the customer and draft the classification consultation form based on the consensus results of the two previous classifiers.
Step 5: Check the legality
The legal compliance officer checks whether the legality of the classification in accordance with the law or not.
Step 6: Inspect & sign the specialized confirmation
The holder of the classification practice certificate conducts the final inspection and signs the classification.
Step 7: Director approval
Attorney/director approves.
Step 8: Send the results to customer
Send hard copy to customer.
Above is detailed information about Vietnam medical device classification process. At MedNovum. Besides that:
☑️ All personnel who involved in Vietnam medical device classification process have a Certificate of Medical Device Classification.
☑️ MedNovum has purchased Professional Liability Insurance for the Vietnam medical device classification since 2019.
☑️ Customers can use Premium fast service to return results within 1 – 4 working days or Basic slow service to return results within 5-7 working days.
If you have any questions or need advice on classification and other regulatory affairs services, please call MedNovum via hotline +84 28 3911 1551, We will contact you within 24 hours to answer your questions and free consultation.
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