SERVICE OF REGISTRATION OF CIRCULATION NUMBERS FOR MEDICAL EQUIPMENT TYPE C, D

Registering circulation number of medical equipment type C, D 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 registering the circulation number of 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 processing 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 registering circulation numbers for medical equipment types C and D. 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 classification A, B, C, D to serve as a basis for Announcement of standards applicable to medical equipment of types A and B or Issuing certificates of registration for circulation of medical equipment types C and D.

Therefore, businesses need to prepare equivalent documents for their type of medical equipment.

Application for certificate of registration for circulation of medical equipment type C, D

For medical equipment of type C and D, enterprises need to prepare the following documents:

– Document requesting new circulation number

– ISO (For domestically produced medical equipment, provide ISO + Receipt of dossier declaring eligibility for production suitable for the product)

– Power of Attorney of Owner (POA)

– Certificate of eligibility for warranty from the owner of the medical equipment

– Certificate of Free Sale (CFS)

– Document summarizing technical description of medical equipment in Vietnamese

– Clinical trial data summary + Clinical trial study results

(Particularly for In vitro diagnostic medical equipment of type C, D, it is provided Certificate of inspection as prescribed by the Minister of Health)

– Label sample to be used when circulating in Vietnam

– User manual in Vietnamese and original

– For reagents, calibrators, and in vitro control materials:

+ Documents on raw materials and product safety

+ Production process and product quality control

+ Clinical and preclinical study reports including stability reports.

+ Quality certificate issued by competent authority of Vietnam

– For chemicals, the only purpose of the preparation is to disinfect medical equipment:

+ Test certificate of ingredients and content of active antibacterial substances

+ Test report to evaluate biological efficacy.

Procedure for registration of circulation number 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 medical equipment registration.

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 unit providing registration services for circulation numbers of medical equipment types C and D 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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