Navigating Medical Device Registration in India and Malaysia: A Comprehensive Guide by Deviceology


The global medical device industry is booming, and emerging markets like India and Malaysia are becoming increasingly attractive destinations for manufacturers. However, the regulatory landscape in these countries can be complex and challenging. This blog aims to demystify the process of medical device registration in India and Malaysia, offering insights into how Deviceology can support your entry into these burgeoning markets.

The Importance of Emerging Markets

Emerging markets like India and Malaysia are not just attractive due to their size but also because of increasing healthcare expenditures, growing awareness about healthcare quality, and rising demand for medical devices. These markets offer a fertile ground for medical device companies looking to expand their global footprint.

Regulatory Authorities and Frameworks


Governed by the Central Drugs Standard Control Organization (CDSCO), the regulatory framework in India is robust and continually evolving. CDSCO operates under the Ministry of Health and Family Welfare (MOHFW) and regulates devices under the Medical Device Rules 2017 and the Medical Devices (Amendment) Rules 2020.


The Medical Device Authority (MDA) is the regulatory body in Malaysia, operating under the Ministry of Health. It regulates devices under the Medical Device Act (Act 737, 2012).

Risk-Based Classification

Both countries employ a risk-based classification system for medical devices:

– **India**: Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk).

– **Malaysia**: Class A to D, similar to India’s classification.

Quality Management Systems and ISO Standards

Both India and Malaysia recognize ISO 13485:2016 as a valid quality management system. This is in line with international standards and regulations, making it easier for companies that already comply with such standards to streamline their registration process.

Market Access Strategies


India differentiates between ‘notified’ and ‘non-notified’ medical devices. Mandatory registration is enforced as of specific dates, and the process involves multiple steps, including online registration and the appointment of a local Indian Authorized Agent (IAA).


Malaysia offers abridged routes to market for devices approved in recognized countries, thus accelerating the approval process. The country also requires the appointment of a local license holder as the authorized representative (AR).

How Deviceology Can Support Your Market Entry

1. Regulatory Consultation: Our team of experts can guide you through the complex regulatory frameworks in India and Malaysia. We ensure that your devices meet all local and international standards, including ISO 13485:2016.

2. Quality Management Systems: Deviceology can assist in implementing or aligning your existing quality management systems to meet the specific requirements of both countries.

3. Market Access Strategy: We offer tailored market access strategies, leveraging our local partnerships and understanding of ‘notified’ and ‘non-notified’ categories in India and abridged routes in Malaysia.

4. Post-Market Surveillance: Our services extend beyond registration. We offer post-market surveillance to ensure ongoing compliance and to manage any regulatory changes effectively.

5. Local Representation: Deviceology can provide a local Authorized Agent or Authorized Representative, fulfilling all local requirements and facilitating smoother market entry.

Registration Validity and Renewals

– India: Licenses are valid indefinitely, provided a License Retention fee is paid every five years.

– Malaysia: Establishment licenses are valid for three years, and device registration is valid for five years.

Latest Regulatory Developments

Both countries are in a transition phase, adopting more stringent regulations. Deviceology stays abreast of these changes to provide timely advice to our clients, ensuring that they are always ahead of the curve.


India and Malaysia offer significant opportunities for medical device manufacturers. However, the regulatory landscape can be challenging. Deviceology is here to simplify this process, offering end-to-end solutions for your market entry and ongoing compliance needs.

Contact Us

For more information on how Deviceology can assist you in entering the Indian and Malaysian medical device markets, please contact us at or visit our website

By leveraging international regulations and ISO standards, Deviceology ensures that your entry into these emerging markets is as smooth as possible, setting the stage for your success. Don’t miss out on these opportunities; reach out to us today to learn how we can support your business expansion.