The Indian medical device industry is strictly regulated. Medical device manufacturers or importers are required to comply with regulatory guidelines as well secure the necessary certificates and licenses. The regulatory approval pathways for medical devices are being revamped for convenience and transparency. Central Drugs Standards Control Organization (CDSCO) is aiming to simplify and digitize its regulatory workflows. The goal is to make the regulatory process faster and more transparent for medical device manufacturers and importers. As of April 9, 2025, CDSCO has implemented an autogenerated market standing certificate and non-conviction certificate workflow system. Hence, medical device manufacturers will have to mandatorily submit fresh applications through the updated online system.
What is market standing certificate (MSC)?
Market standing certificate (MSC) is a document that demonstrates the certified company has a proven track record of business performance. It is issued by the government authority or other authorized bodies to certify the company has a good reputation. This document is usually required for acquiring bank loans and tenders or contracts. This document proves the creditworthiness of the company. The CDSCO is the apex regulatory body for drugs, medical devices, and cosmetics in India. CDSCO market standing certificate is issued to certify the good reputation of the medical device company. The purpose of a CDSCO market standing certificate:
- A CDSCO market standing certificate proves the company has a valid CDSCO manufacturing license.
- It also certifies the fact that the company has been actively manufacturing and selling products in the Indian market.
- This certificate is usually required by foreign regulatory bodies for registering your product in foreign countries.
What is non-conviction certificate (NCC)?
Non-conviction certificate (NCC) is used to certify the company has not been convicted of any violations related to the quality or safety of medical devices. NCC serves as a declaration of legal compliance. The CDSCO issues the NCC to certify the medical device company has not been convicted under the Drugs and Cosmetics Act of 1940. The purpose of a CDSCO NCC is:
- It proves the medical device company has no history of convictions related to safety, quality, or malfunction of the medical device.
CDSCO has implemented autogenerated market standing certificate and non-conviction certificate workflow system
CDSCO is the apex regulatory body for medical devices. The CDSCO has rolled out an upgraded online system for issuing market standing certificate (MSC) and non-conviction certificate (NCC). The new system, integrated into the online system for medical devices, will automatically generate the certificates based on submitted applications. This autogenerated workflow system will simplify the regulatory approval process and is aimed at promoting the ease of doing business. By automating the issuance of MSC and NCC, CDSCO aims to enhance the efficiency of the regulatory approval process. Hence, with the implementation of the automated system on April 9, 2025, companies are required to mandatorily submit fresh applications under the new system.
Benefits of the autogenerated market standing certificate and non-conviction certificate workflow system
By transitioning to an automated system, CDSCO aims to improve the efficiency of the medical device regulatory framework. Moreover, by reducing manual intervention, market standing certificate and non-conviction certificate application process is expected to become smooth and reliable. This autogenerated market standing certificate and non-conviction certificate application process is expected to expedite the issuance of certificates. Thus, it will reduce the processing time as well as improve transparency for all involved parties. With this digital shift, CDSCO is reinforcing its commitment to create a streamlined medical device regulatory system.
Impact of the auto generated MSC and NCC certification system on the medical device industry
We have highlighted what you should know about the new auto-generated certification system and how it will impact you.
- New auto generation system: CDSCO has introduced an auto-generated certification workflow for issuing MSC and NCC. This new system will replace the older manual certification system.
- Eligibility: Only medical device manufacturers and importers with a valid CDSCO medical device license can apply using this new auto-generated certification system.
- Impact on existing MSC and NCC application: Notably, all old MSC and NCC applications are to be voided. Any MSC and NCC applications submitted under the previous system will be automatically rejected by the system. All stakeholders must re-submit fresh MSC and NCC applications to comply with the new system.
What you should do to comply with the new auto generated MSC and NCC certification system?
- Review your current MSC or NCC application status.
- Collate all necessary supporting documents for re-submission of the application.
- Submit fresh MSC or NCC applications on the updated auto certificate generating system.
Pharmadocx Consultants: Your trusted regulatory consultant
We at Pharmadocx Consultants provide an all-encompassing service for CDSCO regulatory compliance in India. Armed with more than 27 years of experience and having served over 600 clients, we have in depth knowledge of the CDSCO regulatory requirements. Moreover, we have helped set up more than 250 manufacturing facilities and plants. We have simplified the CDSCO regulatory journey for all our clients. Our service ranges from licensing and certification to documentation and plant designing. We will be your trusted ally throughout the MSC or NCC application process. We will help you with every step of the regulatory journey.
India aims to be a key player in the global medical device sector. To ensure the medical devices being manufactured in India are at par with global standards, CDSCO keeps updating its regulatory guidelines. Staying abreast of the latest medical device regulations can be overwhelming.
Furthermore, CDSCO has implemented an autogenerated market standing certificate and non-conviction certificate workflow system. This update is expected to expedite the certificate issuance process as well as simplify and streamline the regulatory compliance framework. Moreover, this change will make the regulatory pathway transparent for medical device manufacturers and importers. The updated auto generated MSC and NCC certificate application system can be difficult to navigate. Fret not! We will guide you throughout the application process. Additionally, our team of experts will prepare the necessary documents and ensure the application is per the guidelines. Hence, we will ensure your certificate application process will be seamless without any regulatory hurdles. Simply call/Whatsapp on 9996859227 or email at [email protected] and we will ensure you have a smooth regulatory journey.
