Announcement of standards for applying medical equipment types A and B
ANNOUNCEMENT OF STANDARDS APPLIED TO MEDICAL EQUIPMENT TYPES A AND B
Announcement of standards for applying medical equipment types A and B is a mandatory procedure that must be performed when a business wants to manufacture or import medical equipment products for distribution in Vietnam.
However, the procedure for declaring standards for medical equipment is quite complicated and takes a lot of time in preparing documents as well as handling procedures with state agencies. Therefore, if the unit does not have experience in the steps of handling documents, it will lead to the situation of documents being returned and losing business opportunities for the enterprise.
To help solve these difficulties, MedNovum provides businesses with the service of announcing standards for applying medical equipment types A and B. Fast - Accurate - Professional, ensuring time with the most reasonable cost.
What documents do businesses need to prepare?
According to Decree 98, all medical equipment must be classified as A, B, C, D to serve as a basis for announcing applicable standards for medical equipment of type A, B or granting certificates of registration for circulation of medical equipment of type C, D.
Therefore, businesses need to prepare equivalent documents for their type of medical equipment.
Profile of Announcement of applicable standards for medical equipment types A, B
For medical equipment of type A and B, enterprises need to prepare the following documents:
– Document announcing the standards for applying medical equipment types A and B
– ISO 13485
– Power of Attorney (LOA)
– Certificate of eligibility for warranty of medical equipment (except disposable medical equipment)
– Certificate of conformity according to regulations or product standards published by the owner of the medical equipment. (DOC)
– Technical documents
– Catalogue issued by the owner
– User manual (Vietnamese and English)
– Label sample to be used when circulating in Vietnam
– Certificate of Free Sale (CFS) for imported medical equipment.
– For reagents, calibrators, and in vitro control materials:
+ TLKT in Vietnamese
+ Documentation on raw materials, product safety, manufacturing processes, clinical and preclinical research reports including stability reports.
– For domestically produced in vitro diagnostic medical equipment:
+ Results of assessment of chemical, physical, microbiological and other parameters or Certificate of quality assessment issued by a competent authority of Vietnam
Procedure for implementing standards announcement applied at MedNovum
With the working motto of always putting the interests of customers first, MedNovum team always tries to complete each step carefully to bring the most convenient service to customers.
Step 1: Free consultation for businesses on legal issues related to the announcement of standards applied to medical equipment.
Step 2: Businesses prepare and submit documents according to dedicated guidance from MedNovum.
Step 3: After receiving, checking and evaluating the legality of consulting requests and business documents, MedNovum will send a quote to the business.
Step 4: After the customer agrees on the proposed MedNovum quote, we will represent the business to process the documents, work with the competent state agencies, and complete all procedures. The results will be returned to the business as soon as possible.
Step 5: After returning the results, MedNovum will still provide long-term support to customers on legal issues related to the service.
MedNovum – A prestigious provider of standards announcement services for medical equipment in Vietnam
With 5 years of experience specializing in providing medical equipment legal services, MedNovum is confident that it will be a partner to accompany businesses in successfully accessing the potential medical equipment market in Vietnam.
- Save time: MedNovum's profile is correct from the first approval, avoiding the situation of adding additional documents which is time-consuming.
- Risk mitigation: Ensure easy customs clearance, limit long-term risks for customers.
- Highly qualified staff: The staff at MedNovum are lawyers, doctors, and pharmacists with high professional qualifications, knowledge of the law, and many years of experience in the field of medical equipment.
- World leading partners: MedNovum's partners are the world's leading medical equipment companies such as: Medtronic, Fujifilm, Waters Corporation, Delcon SRL, Hans Biomed, Beckman Coulter, Stryker, Streck,...
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