DECLARATION OF APPLIED STANDARDS FOR CLASS A OR CLASS B MEDICAL DEVICES
Declaration of applied standards for class A or class B medical devices is a compulsory when an organization wishes to distribute medical devices within the territory of Vietnam.
However, this procedure is quite complicated and might take much time in completing dossiers as well as other procedures related to Government Agencies. Therefore, organizations with no experience in processing dossiers usually got their dossiers returned back and lost business opportunities.
In order to support organizations to solve these difficulties, MedNovum wishes to provide a full package service with a reasonable price and time – saving. Client’s interest is one of the aspect that we care most, therefore, highly skill team of MedNovum is always ready to serve clients at our best.
What applications do organizations need to prepare?
According to Decree 98, all medical devices must be classified A, B, C, D that serves as the basis for the declaration of applied standards for class A, B medical devices or issue certificates of registration of class C, D medical devices.
Therefore, organizations need to prepare equivalent applications for your medical devices.
The application for declaration of applied standards of Class-A or Class-B medical device
– Application Form
– ISO 13485
– Letter of Authorization issued by Product Owner (LOA)
– Letter of Warranty by the product owner OR Non-Warranty confirmation by distributor
– Declaration of conformity (DOC)
– Technical summary in Vietnamese
– Catalogue issued by the product owner
– Instructions for use (IFU) in English and Vietnamese
– Original Label And Sub-Label
– Certificate of free sale (CFS)
– For IVD medical devices:
+ Documents on materials and safety of the product
+ Documents on manufacturing process
+ Stability report
– For Non-IVD medical devices:
+ Clinical Evaluation Report
The process of consulting on declaration of applied standards at MedNovum
With the working principle of putting the interests of our clients first, the MedNovum team always tries to complete each step carefully to bring the most convenient service to clients.
Step 1: Free consultation for client on legal issues related to declaration of applied standards for class A or class B medical devices.
Step 2: Client prepares and sends applications according to the dedicated guidance from MedNovum.
Step 3: After receiving, verifying, evaluating the legal characteristics of consultation requirements and client’s documents, MedNovum sends a price quotation to client.
Step 4: When client agrees on the price quotation, we will apply the applications, work with the competent state agency and complete all procedures on behalf of you. Results will be returned to you as soon as possible.
Step 5: After returning the results, MedNovum will still provide long-term support to client with legal issues related to the service.
MedNovum – A reputable and professional declaration of applied standards consulting unit in Vietnam
With 5 years of experience specializing in providing legal services for medical devices, MedNovum is confident to be a partner with businesses in successfully accessing the potential medical devices market in Vietnam.
- Time-saving: The applications will be correct from the first approval that avoids the time-consuming situation of supplementing applications.
- Avoid Taking Risk: Ensure to implement the custom clearance procedure easily and minimize any long-term risk for the clients.
- Expert team: MedNovum’s team is lawyers, doctors, pharmacists with extensive experience in the field of law and medical device.
- Be a partner of the world’s leading companies: MedNovum is the pioneers in Marketing Authorisation Holder service in Vietnam and is chosen as a partner by the world’s leading manufacturers such as Medtronic, Fujifilm, Waters Corporation, Delcon SRL, Hans Biomed, Beckman Coulter, Stryker, Streck,…
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