A Complete Guide to CDSCO Certification for Medical Consumables Manufacturers

For medical consumables manufacturers in India, CDSCO certification is like a hallmark. It guarantees the quality, safety, and durability of the product. So, let’s understand the steps involved in a complete guide to CDSCO certification for medical consumables manufacturers. 

1. Registration 

• SUGAM portal is the online portal for CDSCO applications. Create an account on the SUGAM portal.
• It’s important to fill out the appropriate form according to the class of devices your manufactured medical consumables belong to. Form MD-14 is for class A/B devices. And form MD-15 is for class C/D devices.
• During registration, you need to upload several relevant documents, without which your registration is incomplete. So make sure that you share all legitimate information regarding medical consumables, manufacturer information and free sale certificate from the country of origin.

2. CDSCO Review

• Make sure you carefully go through a complete guide to CDSCO certification for medical consumables manufacturers. Once all the information is shared and the documents are uploaded, the CDSCO reviews and may verify the information. 
• If your application is incomplete or has discrepancies, additional information or documentation might be requested by the CDSCO.

3. Inspection 

• This is one of the most important steps in attaining CDSCO certification so make sure that your manufacturing facility complies with Good Manufacturing Practices (GMP) and ISO 13485 standards. 
• A team from CDSCO will conduct the inspection and make an inspection report.

4.  Approval & lisencing 

• If your application is approved, a registration certification will be issued to your firm, and an import/manufacturing license will be allotted to it. 
• Your attained license will be valid for a period of 5 years, after which you will have to renew the same.
• Make sure you download and save your CDSCO certificate through the SUGAM portal.                              

We at Surgikart have thoroughly followed a complete guide to CDSCO certification for medical consumables manufacturers. We manufacture surgical disposables at par with global standards and strive to maintain safety, quality and compliance with regulatory standards while constantly chasing innovative technology to improve our products. At our in-house sterilisation plant, clean room and quality control laboratory, we maintain international standards and deliver reliable products of unparalleled quality. With over 40 product categories, offering the best in market customisation, we at Surgikart are poised to be your trusted partner in this journey.