PROCEDURE AND PROCEDURES FOR EXPORTING MEDICAL MEDICAL MEDICAL MEDICAL MARKET INTO US MARKET.
During the Covid pandemic, masks are always an extremely necessary item. Americans do not have the habit of using masks, but the Covid pandemic has changed everything. Americans have worn masks regularly and returned to a mandatory regulation during the pandemic of some states. The US government is increasing the import of masks in countries to meet the needs of the people. And Vietnam has become one of the largest exporters of medical masks to the market of the most developed country in the world.
But for Vietnamese businesses to export masks to the US market, they need to go through many processes and register the necessary procedures to be able to export. Therefore, we and the FDA certification registration service provider for medical device products exported to the United States will specify specific requirements and processes for businesses to understand and implement.
I. LEGAL BASIS OF THE GOVERNMENT.
According to Decree 36/2016/ND-CP of the Government on management of medical equipment.
Decree 169/2018/ND-CP amending and supplementing a number of articles of Decree 36/2016/ND-CP of the Government on management of medical equipment.
Circular 39/2016/TT-BYT on classification of medical equipment.
II. IMPLEMENTATION OF ELIGIBILITY FOR MANUFACTURING MEDICAL EQUIPMENT (HERE IS A MEDICAL DEVICE).
Enterprises/manufacturers must meet the requirements for professional managers, facilities at the place of production (manufacturing workshops) and with the following documents and procedures:
- Dossier of declaration of eligibility to produce medical masks:
- Business registration certificate.
- Written declaration of eligibility for production.
- Personnel manifest.
- Documents on assignment and appointment of person in charge of expertise.
- Diplomas and certificates of the professional person in charge.
- Certificate of meeting quality management standards recognized by conformity assessment organizations as prescribed by law.
- Documents proving that other conditions are met.
- Working time: 10-15 days.
III. CLASSIFICATION OF MEDICAL DEVICES (MEDICAL FACES).
Before announcing the standards for applying medical masks, enterprises/manufacturers must conduct specific classification of medical masks as follows.
Classification profiles include:
1. Written request for classification of medical equipment.
2. Document technical description of the product.
3. Product catalog.
4. Certificate of quality standard production system management.
5. Certificate of Free Sale
6. Receipt of dossiers of production facilities eligible for production (if any).
7. Working time: 1-2 days.
IV. ANNOUNCEMENT OF STANDARDS FOR APPLICATION OF MEDICAL DEVICES (HERE IS A MEDICAL AVERAGE).
Manufacturers/enterprises who want to export medical masks must announce the standards applicable to medical masks.
The application standard declaration dossier includes:
- Classification results.
- Certificate of eligibility for warranty.
- Technical brief description document.
- Instruction document.
- ISO certificate.
- Label template.
- Results of testing the physical, chemical and microbiological costs of the product for domestically produced equipment.
- Receipt for registration of announcement of eligibility to manufacture medical equipment...
- Working time: 10-15 days.
V. REGISTRATION FOR FREE SALE OF MEDICAL EQUIPMENT (HERE IS A MEDICAL MASK).
Dossier for registration of free sale of medical masks include:
- A written request for a certificate of free sale.
- Papers as prescribed in Article 22.
- Dossier of application for a certificate of free sale for medical equipment must satisfy the requirements specified in Article 23.
- Dossier of application for a certificate of free sale for medical equipment with a free sale number.
VI. REGISTER FOR MEDICAL EQUIPMENT CODE, BRAND CODE (HERE IS A MEDICAL MEDICAL AVERAGE).
A dossier for registration of a medical mask barcode number includes:
- Certified copy of business registration certificate.
– The registration of barcode number, filled in with information, signed by the head.
- List of products using barcodes (features, types, volumes, quantities, and sizes of products).
- Receipt of application form.
– Number of records: 2 sets.
- Implementation time: 2-3 days.
VII. FDA REGISTRATION FOR MEDICAL MASK (REQUIRED PROCEDURES FOR EXPORT TO US).
For the US market, the manufacturer/enterprise wants to bring this item to the US market, the enterprise is required to register for FDA.
FDA registration documents:
Certificate of business registration.
Address of production facility.
Other information.
Note: Manufacturers/enterprises please send information or contact us directly for instructions and registration support.
