Services

We at BioState specializes in providing regulatory compliance, market intelligence, quality assurance & clinical consulting services to global medical device & IVD manufacturers or suppliers want to market our launch their product in India. We offer full service regulatory & product development consulting services for IVDs & Medical devices. We provide our help in the pre-market investigation, regulatory strategy, clinical study, quality assurance, and risk management, registration & market approval in India. So we at Biostate provide help in efficient & effective product registration services. And we help you import & market your products in India efficiently through faster product approvals from Indian govt. regulatory firms to enhance the market opportunities.

We focus on providing our clients a deep knowledge of the challenges, operations & best practices in the healthcare sector, more specifically related to clinical diagnostics. We provide expert management consulting services in medical devices & IVD industry in areas related to business transformation, innovation & market disruption.

We collaborate with our clients on everything from developing a Go-To-Market-level business vision to detailing day-to-day operations. Experienced in navigating through various regulatory frameworks and developing effective regulatory strategies to deliver regulatory agency approval, authoring various types of regulatory submissions, interacting with regulatory agencies during review, and managing post-approval changes.

In India, the Central Drugs Standard Control Organisation or CDSCO, manned by the Directorate General of Health Services under the aegis of the Ministry of Health and Family Welfare, governs the regulatory ecosystem for medical devices.

Strict procedures must be followed in accordance with the norms and guidelines established by the Central Drug Standard Control Organization while manufacturing Medical Devices (CDSCO)

BioState has the experience and expertise to fulfil the entire regulatory process with a zero-defect capability.

ABOUT CLASS A, B, C and D Medical Devices

As per the New Medical Rules, 2017, all medical devices have been classified into four distinct classes. According to the MDR, the categories are Class A, Class B and Class C, and Class D

For easy identification, CDSCO has classified these devices into four categories:

• Class A: Low risk – Absorbent cotton wool, surgical dressing, alcohol swabs, etc.
• Class B: Low moderate risk – Thermometer, BP measuring devices, disinfectants, etc.
• Class C: Moderate high risk – Implants, hemodialysis catheter, etc.
• Class D: High risk – Heart valve, angiographic guide, etc.

COSMETIC REGISTRATION

DEFINITION OF COSMETIC

Cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to the human body or any part thereof for cleansing ,beautifying, promoting attractiveness, or altering the appearance and includes any article intended for use as a component of cosmetic.

Bio State experts help our clients navigate through the tough , complex and often changing regulatory requirements regulating Cosmetics in India .The cosmetic registration process requires meticulous planning and review of the ingredients and labeling for registration in India. Any company intending to import and market cosmetic products has to go through this tedious process. The cosmetic application should clearly define the products in respective categories. With years of experience behind us in assisting several product registrations and certifications, we are the regulatory partner need with you through the entire process in completing the registrations without any glitches.