11/11/2025
Streamline IVD licensing in India with the help of Accredited Consultants Pvt. Ltd
(ACPL) covering ...
𝐒𝐭𝐫𝐞𝐚𝐦𝐥𝐢𝐧𝐞 𝐈𝐕𝐃 𝐥𝐢𝐜𝐞𝐧𝐬𝐢𝐧𝐠 in India with the help of Accredited Consultants Pvt. Ltd
(ACPL) covering key challenges,
regulatory framework, ACPL’s value proposition, step-by-step process, best
practices, and how to make the most of their services.
1.
𝐓𝐡𝐞 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐋𝐚𝐧𝐝𝐬𝐜𝐚𝐩𝐞 𝐟𝐨𝐫 𝐈𝐕𝐃𝐬 𝐢𝐧 𝐈𝐧𝐝𝐢𝐚
Understanding the regulatory
backdrop is essential for efficient licensing of in vitro diagnostic (IVD)
devices.
In India, IVDs are regulated as medical devices under
the Central Drugs Standard Control Organization (CDSCO) via the Medical Devices
Rules, 2017 (MDR 2017).
IVDs are classified into 𝐂𝐥𝐚𝐬𝐬 𝐀, 𝐁, 𝐂, 𝐃 (low
risk → high risk) depending on intended use, risk profile and impact to
public health.
Depending on whether you are importing, manufacturing,
distributing or conducting clinical performance evaluation, there are
different application forms (e.g., MD-14/MD-15 for import license,
MD-7/MD-9 for manufacturing class C/D) and varying regulatory authorities
(Central vs State).
Additional requirements may include: ISO 13485 certification
(for QMS), Free Sale Certificate (FSC) from country of origin, data on
clinical performance evaluation (especially for higher-risk classes), lab
testing & compliance, labelling and post-market surveillance.
Regulatory approvals may be time-consuming, requiring
coordination of various stakeholders, correct documentation, and follow-up
with authorities, and readiness for inspections.
Because of these complexities,
licensing IVDs in India can be daunting. That’s where ACPL comes into-play.
2.
𝐖𝐡𝐲 𝐔𝐬𝐞 𝐀𝐜𝐜𝐫𝐞𝐝𝐢𝐭𝐞𝐝 𝐂𝐨𝐧𝐬𝐮𝐥𝐭𝐚𝐧𝐭𝐬 𝐏𝐯𝐭. 𝐋𝐭𝐝. (𝐀𝐂𝐏𝐋) 𝐟𝐨𝐫 𝐈𝐕𝐃 𝐋𝐢𝐜𝐞𝐧𝐬𝐢𝐧𝐠
ACPL offers a specialized regulatory
consulting service, particularly for medical devices and IVDs. Some of the
value they bring:
They have deep expertise in device/IVD regulatory
pathways in India (import, manufacture, distribution) as part of their
portfolio of services.
They help navigate “India entry strategy” for IVD
companies—covering incorporation/agent appointment, regulatory compliance,
market assessment and go-to-market planning.
They provide end-to-end services: documentation
preparation, dossier submission, liaison with CDSCO/State authorities, post-market
surveillance, etc.
Their expertise reduces risk of delays, rejections or
additional queries by regulators — meaning smoother, faster licensing.
They are a trusted partner when you have limited
internal regulatory resources or are entering the Indian market from
abroad.
In short: partnering with ACPL can
significantly streamline your IVD licensing path, allowing you to focus on
product development, quality and market ex*****on.
3.
𝐒𝐭𝐫𝐞𝐚𝐦𝐥𝐢𝐧𝐞 𝐈𝐕𝐃 𝐋𝐢𝐜𝐞𝐧𝐬𝐢𝐧𝐠 𝐰𝐢𝐭𝐡 𝐀𝐂𝐏𝐋
Here’s a recommended process,
showing how ACPL can be engaged at each stage:
𝐒𝐭𝐞𝐩
1: 𝐏𝐫𝐞-𝐏𝐥𝐚𝐧𝐧𝐢𝐧𝐠 & 𝐆𝐚𝐩 𝐀𝐧𝐚𝐥𝐲𝐬𝐢𝐬
ACPL conducts a regulatory gap assessment: evaluate
your IVD product (class, risk, intended use), check compliance status (ISO
13485, labelling, FSC, clinical data) and map the required Indian
regulatory pathway.
They identify whether you require import licence,
manufacturing licence, or both; which forms apply; what documentation is
missing; what timelines to expect.
They help define the project plan: milestones,
responsibilities (your team vs ACPL), regulatory budget, and timeline.
𝐒𝐭𝐞𝐩
2: 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐲 & 𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧 𝐏𝐫𝐞𝐩𝐚𝐫𝐚𝐭𝐢𝐨𝐧
Based on the gap assessment, ACPL helps you develop a
tailored regulatory strategy: e.g., for Class C/D IVDs you may need
clinical performance evaluation and manufacturing licence from CDSCO; for
lower classes maybe a simpler state licence.
They help compile the technical dossier: master files
(PMF/DMF), device description and specifications, labelling, risk
management, performance evaluation reports, FSC from country of origin,
ISO 13485 certificate, stability/validation data if required. Such items
are indicated in reference materials.
They assist in filling the correct regulatory forms (e.g.,
MD-14/MD-15 for import license) and ensure correct submission via Sugam portal
or offline as applicable.
They prepare supporting documents: Power of Attorney
(POA), cover letter, notarization (if required) and ensure all
documentation is consistent.
𝐒𝐭𝐞𝐩
3: 𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 & 𝐋𝐢𝐚𝐢𝐬𝐨𝐧 𝐰𝐢𝐭𝐡 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫
ACPL handles submission of the application to the
appropriate authority (central or state) along with checklist, fees,
pay-in-slips etc.
They monitor the progress: respond to queries, follow
up with regulators, and coordinate with your team for additional data or
clarifications.
For inspections (if required) they help you prepare:
inspection readiness, staffing, QMS audit, manufacturing site compliance
(if applying for manufacture).
They keep you updated on timelines and anticipated
approval date.
𝐒𝐭𝐞𝐩
4: 𝐏𝐨𝐬𝐭-𝐀𝐩𝐩𝐫𝐨𝐯𝐚𝐥 𝐀𝐜𝐭𝐢𝐯𝐢𝐭𝐢𝐞𝐬
Once licence is granted, ACPL supports you with
post-market surveillance: e.g., complaints, adverse event reporting, PMS
protocols, performance monitoring.
They can assist with modifications/variations: if you
change manufacturing site, add new variants, change labelling, etc., then
amendment filings are needed.
They advise compliance with other connected
regulations: labelling rules, import/export licensing, state-level
distribution licences, maintaining records of sale/distribution.
They can assist in training your internal team on
regulatory compliance and handling inspections.
𝐒𝐭𝐞𝐩
5: 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐀𝐝𝐯𝐢𝐬𝐨𝐫𝐲 & 𝐌𝐚𝐫𝐤𝐞𝐭 𝐄𝐧𝐭𝐫𝐲
ACPL can help you with broader market-entry strategy:
identifying distribution partners, pricing strategy, localised
labelling/instruction for use, regional regulatory nuances.
They also assist if you plan global exports: helping
align your Indian licence with export markets, understanding CE/US
FDA/other jurisdictions, and managing your India entity/licensing
footprint.
4.
𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐞𝐬 𝐭𝐨 𝐄𝐧𝐬𝐮𝐫𝐞 𝐒𝐭𝐫𝐞𝐚𝐦𝐥𝐢𝐧𝐢𝐧𝐠
To get the maximum benefit from ACPL
(and to streamline licensing yourself), here are best practices:
𝐄𝐚𝐫𝐥𝐲 𝐞𝐧𝐠𝐚𝐠𝐞𝐦𝐞𝐧𝐭:
Engage ACPL early in your product development lifecycle rather than
waiting until you are ready to submit. This avoids last-minute surprises.
𝐂𝐥𝐞𝐚𝐫 𝐬𝐜𝐨𝐩𝐞 & 𝐝𝐞𝐥𝐢𝐯𝐞𝐫𝐚𝐛𝐥𝐞𝐬: Agree with ACPL on scope of work (which forms, which
authorities, timeline, fees) and define responsibilities between you and
the consultant.
𝐀𝐜𝐜𝐮𝐫𝐚𝐭𝐞 𝐜𝐥𝐚𝐬𝐬𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧: Ensure your product is properly classified (A/B/C/D)
since mis-classification causes delays or re-submission. Use CDSCO
classification list.
𝐂𝐨𝐦𝐩𝐥𝐞𝐭𝐞 𝐝𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧: Ensure technical files, quality system, performance
data, FSC, labelling etc are complete and aligned. Missing documents are
the leading cause of delays.
𝐏𝐫𝐞𝐩𝐚𝐫𝐞 𝐟𝐨𝐫 𝐜𝐡𝐚𝐧𝐠𝐞:
Regulatory frameworks evolve. For example, new guidance on IVD performance
evaluation have been issued.
𝐌𝐚𝐢𝐧𝐭𝐚𝐢𝐧 𝐪𝐮𝐚𝐥𝐢𝐭𝐲 𝐬𝐲𝐬𝐭𝐞𝐦: A functioning QMS (preferably ISO 13485) supports
manufacturing licence and reinforces credibility with regulators.
𝐌𝐚𝐢𝐧𝐭𝐚𝐢𝐧 𝐜𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧: Regular updates between your internal team and ACPL
ensure issues are flagged early, and progress remains on track.
𝐏𝐨𝐬𝐭-𝐚𝐩𝐩𝐫𝐨𝐯𝐚𝐥 𝐯𝐢𝐠𝐢𝐥𝐚𝐧𝐜𝐞: Licensing is not the end. You must maintain
compliance, monitor products in market, and manage complaints and
regulatory changes. ACPL can guide you on this but internal discipline is
required.
5.
𝐓𝐲𝐩𝐢𝐜𝐚𝐥 𝐂𝐡𝐚𝐥𝐥𝐞𝐧𝐠𝐞𝐬 𝐚𝐧𝐝 𝐇𝐨𝐰 𝐀𝐂𝐏𝐋 𝐇𝐞𝐥𝐩𝐬 𝐎𝐯𝐞𝐫𝐜𝐨𝐦𝐞 𝐓𝐡𝐞𝐦
Some common licensing hurdles and
how ACPL helps you pre-empt them:
𝐀𝐦𝐛𝐢𝐠𝐮𝐨𝐮𝐬 𝐜𝐥𝐚𝐬𝐬𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐩𝐚𝐭𝐡: Many companies are unclear whether they need import
licence vs manufacture licence. ACPL clarifies that from the start.
𝐈𝐧𝐜𝐨𝐦𝐩𝐥𝐞𝐭𝐞 𝐝𝐨𝐬𝐬𝐢𝐞𝐫/𝐭𝐞𝐜𝐡𝐧𝐢𝐜𝐚𝐥 𝐟𝐢𝐥𝐞𝐬: Missing Free Sale Certificates, incomplete PMF/DMF, and
inconsistent labelling cause regulators to ask for additional data. ACPL
reviews and ensures completeness.
𝐃𝐞𝐥𝐚𝐲𝐬 𝐢𝐧 𝐬𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧/𝐟𝐨𝐥𝐥𝐨𝐰-𝐮𝐩𝐬: Regulators may take time; without follow-up things
stagnate. ACPL stays on top, monitor’s status and pursues queries.
𝐈𝐧𝐬𝐩𝐞𝐜𝐭𝐢𝐨𝐧 𝐫𝐞𝐚𝐝𝐢𝐧𝐞𝐬𝐬:
Manufacturing site audits are often overlooked. ACPL helps you prepare
check-lists, mock audits, training and documentation so you pass the
inspection.
𝐕𝐚𝐫𝐢𝐚𝐭𝐢𝐨𝐧𝐬 𝐚𝐧𝐝 𝐚𝐦𝐞𝐧𝐝𝐦𝐞𝐧𝐭𝐬: After initial licence, changes (models, sites,
variants) need amendments. ACPL ensures you have a system to handle this
and file timely changes.
𝐏𝐨𝐬𝐭-𝐦𝐚𝐫𝐤𝐞𝐭 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: Many firms focus only on the licence and ignore
surveillance or adverse event reporting. ACPL ensures you establish those
mechanisms so you remain compliant.
6.
𝐓𝐡𝐢𝐬 𝐌𝐚𝐭𝐭𝐞𝐫𝐬: 𝐁𝐞𝐧𝐞𝐟𝐢𝐭𝐬 𝐨𝐟 𝐒𝐭𝐫𝐞𝐚𝐦𝐥𝐢𝐧𝐞𝐝 𝐈𝐕𝐃 𝐋𝐢𝐜𝐞𝐧𝐬𝐢𝐧𝐠
Getting your IVD licence efficiently
brings multiple tangible benefits:
𝐒𝐩𝐞𝐞𝐝 𝐭𝐨 𝐦𝐚𝐫𝐤𝐞𝐭:
The faster you get approval, the sooner you can commercialise, capture
market share and start generating revenue.
𝐂𝐨𝐬𝐭-𝐞𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲:
Delays cost more — consultancy time, regulatory queries, potential product
expiry, lost opportunity. Partnering with ACPL mitigates cost.
𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐜𝐞𝐫𝐭𝐚𝐢𝐧𝐭𝐲:
With an experienced consultant you reduce the risk of regulatory
surprises, non-compliance, rejection or recalls.
𝐂𝐨𝐦𝐩𝐞𝐭𝐢𝐭𝐢𝐯𝐞 𝐚𝐝𝐯𝐚𝐧𝐭𝐚𝐠𝐞:
Being one of the early compliant players in India positions you favourably
with health-care institutions, distributors and customers.
𝐑𝐞𝐩𝐮𝐭𝐚𝐭𝐢𝐨𝐧 & 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐜𝐮𝐥𝐭𝐮𝐫𝐞: A disciplined approach to licensing signals quality,
reliability and trust—not just to regulators but to customers, partners
and investors.
𝐅𝐨𝐮𝐧𝐝𝐚𝐭𝐢𝐨𝐧 𝐟𝐨𝐫 𝐞𝐱𝐩𝐨𝐫𝐭/𝐠𝐫𝐨𝐰𝐭𝐡: Having your Indian licensing and compliance in place
positions you for further expansions, new markets, additional models or
variants.
7.
𝐀𝐂𝐏𝐋 𝐢𝐬 𝐚 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐂𝐡𝐨𝐢𝐜𝐞
ACPL’s multi‐domain expertise (medical devices, IVDs,
drugs, cosmetics) means they understand the broader ecosystem.
They provide tailored “India entry strategy”
service—helpful if you are an international IVD manufacturer entering
India for the first time.
With regional presence and years of experience, they
are well-positioned to liaise with Indian regulators and help you navigate
approvals efficiently.
Their services extend beyond licence grant — into
post-market surveillance, export assistance and broader regulatory
lifecycle support.
8.
𝐀𝐜𝐭𝐢𝐨𝐧 𝐏𝐥𝐚𝐧: 𝐄𝐧𝐠𝐚𝐠𝐢𝐧𝐠 𝐀𝐂𝐏𝐋 & 𝐘𝐨𝐮𝐫 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐥 𝐓𝐞𝐚𝐦
Here’s a quick action plan to engage
ACPL effectively:
𝐊𝐢𝐜𝐤-𝐨𝐟𝐟 𝐦𝐞𝐞𝐭𝐢𝐧𝐠:
Provide ACPL with product specification, manufacturing/ import plans,
target markets, timeline, internal regulatory/QMS status.
𝐆𝐚𝐩-𝐚𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭 𝐫𝐞𝐩𝐨𝐫𝐭:
ACPL returns with a gap-analysis and regulatory strategy document classification,
required forms, supporting docs, timeline, and cost.
𝐒𝐜𝐨𝐩𝐞 & 𝐜𝐨𝐧𝐭𝐫𝐚𝐜𝐭:
Agree on the scope of work, deliverables, timeline, fees and
responsibilities (both parties).
𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧 𝐰𝐨𝐫𝐤:
Your team (with ACPL support) compiles technical dossier, QMS documents,
labelling, FSC, performance data etc.
𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 & 𝐟𝐨𝐥𝐥𝐨𝐰 𝐮𝐩: ACPL submits application (import/manufacture) and
monitors status, liaises with regulator, addresses queries.
𝐀𝐩𝐩𝐫𝐨𝐯𝐚𝐥 & 𝐥𝐢𝐜𝐞𝐧𝐜𝐞 𝐠𝐫𝐚𝐧𝐭: Once licence is issued, ACPL guides you on compliance
obligations, record keeping, distribution licensing, and post-market
surveillance.
𝐂𝐨𝐧𝐭𝐢𝐧𝐮𝐨𝐮𝐬 𝐬𝐮𝐩𝐩𝐨𝐫𝐭:
For future variants, amendments, export registration, audits and
regulatory updates, retain ACPL as your regulatory partner.
For more information visit our
official website 𝐡𝐭𝐭𝐩𝐬://𝐚𝐜𝐩𝐥𝐠𝐫𝐨𝐮𝐩𝐢𝐧𝐝𝐢𝐚.𝐜𝐨.𝐢𝐧
Email: info@acplgroupindia.co
Social Medias: accreditedconsultantsPrivatelimited
For more info visit us at https://www.acplgroupindia.in/latest-updates/1?utm_source=facebookpage
