Things you should know about medical device registration in India and Malaysia I Medical Device Rules 2017 and 2020 & Medical Device Act (Act 737, 2012)
This blog is part of a series covering general regulatory requirements and developments in Asia-Pacific and LATAM countries. In this blog, the jurisdictions of attention are India and Malaysia.
In India, the Central Drugs Standard Control Organization (CDSCO) is the authority responsible for medical device and in-vitro diagnostic devices (IVD) registration, approval, and administration. CDSCO is governed by the Ministry of Health and Family Welfare (MOHFW). It regulates medical devices and IVD devices under provisions of the Medical Device Rules 2017 and the newly introduced Medical Devices (Amendment) Rules 2020. Underlying is the Drug and Cosmetics Act 1940.
Medical devices are classified following a risk-based approach comparable with the European Union and the FDA classification systems. The range spans from low risk as Class A, low-moderate risk as Class B, moderate-high risk as Class C, and high risk as Class D. The Central Licensing Authority (CLA) shall classify the medical devices. CDSCO lists the devices category and specifies which products shall be considered as medical devices for registration. Class A devices can be considered self-declaration and must be registered in the Indian online system. Details such as manufacturer’s name, address, product generic name, and brand name must be provided. The importers are required to do the same online registration as well.
All medical devices shall obtain a manufacturing import permit approved by CDSCO before being legally distributed in the market. The application for this permit can be submitted via the online portal SUGAM.
If a company does not have a physical establishment in India, it is required to appoint a local Indian Authorized Agent (IAA) for both notified and non-notified devices. Multiple Authorized Agents can register the same product. The authorized agent can be a foreign company’s local office, an independent agency, or an appointed natural person.
CDSCO distinguishes between ‘notified’ and ‘non-notified’ medical devices, based on a listing of 37 categories. Registration was mandatory for the 37 categories on ‘notified’ medical devices list, while ‘non-notified’ medical devices could voluntarily apply for registration. Otherwise, a listing was sufficient. This was possible until 30 September 2021. The CDSCO enforced a transition for all non-notified medical devices to mandatory registration differentiation between Class A/B and Class C/D. All medical devices with risk classes A and B must be registered as of 1 October 2022, while all Class C and D devices have until 1 October 2023.
Two types of registration pathways may allow for an abridged route to market.
Option 1: Predicate device and approval in a GHTF* country.
India recognizes certain countries’ regulatory approvals to decrease overall review timelines and complete a simplified assessment process. The FDA follows a faster assessment pathway for devices approved under the scope of a CE mark, than those without. Conformity to ISO13485:2016 is a recognized quality management system in India.
Option 2: Predicate device and no approval in a GHTF country.
If there is no reference country regulatory approval, the Special Expert Committee (SEC) will execute the technical assessment process. The review lead times depend on the type of device and associated risk class.
If there is no predicate device or prior approval in a GHTF country, the device falls under an ‘Investigational Medical Device’. The SEC focuses on the requirements for clinical evidence and the performance of the devices remaining unchanged in the Indian population. The SEC will consider the need for clinical investigations, clinical trials, and post-market clinical data collection.
Import License or license to manufacture issued under Medical Devices Rules, 2017 shall be perpetually valid until suspension or cancellation, provided that the License Retention fee is paid every five years.
Curious about the details of the market access routes? We will explain more about this during our free webinar on the 7th of September: Medical Device Registration Asia-Pacific II.
In Malaysia, the Medical Device Authority (MDA) under the governance of the Ministry of Health Malaysia, is the authority responsible for medical device management. MDA regulates medical devices under the Medical Device Act (Act 737, 2012).
Medical devices are classified on a risk basis from class A, B, C, and D. Class A is the lowest risk, and Class D is the highest risk. All medical devices must be registered with MDA since 1st July 2016, and the application can be submitted via Malaysia’s online Medical Device Centralized Online Application System (MeDC@St). Applications of class B, C, and D devices will be reviewed by a registered Conformity Assessment Body (CAB) for approval, which plays a role similar to the European notify body.
Based on CAB’s evaluation, MDA will grant the final approval, and the approved product will be listed on the MDA website. Class A devices are exempt from such procedure and can directly submit through MeDC@St. Like other countries, the basic principle of the conformity assessment is to collect evidence and demonstrate that the intended device meets the applicable essential principles of safety and performance. The details of conformity assessment involve a review of four parts:
- Quality management system
- Technical documentation
- Declaration of conformity
- Post-market surveillance.
If a foreign company does not have a physical establishment in Malaysia, it is required to appoint a local license holder to be the authorized representative (AR). AR shall be responsible for the device registration on behalf of the foreign manufacturers and take on the following duties.
- Act on foreign manufacturers’ behalf to conduct the conformity assessment, apply for review with CAB, and obtain approval from MDA;
- Establish, maintain, and implement an appropriate quality management system;
- Obtain establishment license;
- List its name, address, and contact on the label of represented devices;Maintain communication between CAB and MDA and the foreign manufacturer;
Handle post-market activities and post-approval change management.
Only one AR shall represent one product.
Malaysia introduced abridged routes to the market where foreign manufacturers could lodge their approval from other countries. Overall, the market access approach is getting more aligned with the Singapore approach. For example, for products that have already undergone the conformity assessment and are approved in recognized countries such as Australia, Canada, EU, Japan, and the USA, the CAB review process will be simplified, and the whole approval process will be accelerated.
If the devices have not been approved in the recognized countries, a full CAB assessment will be performed for class B, C, and D devices for validation and verification. A technical file compilation based on the Common Submission Dossier Template shall be prepared and submitted to MDA for final approval. Conformity to ISO13485:2016 is a recognized quality management system in Malaysia.
All manufacturers, authorized representatives (AR), importers, and distributors must apply for an establishment license. The validity of the establishment license is three years, and license renewal shall be applied one year prior to its expiry date. All manufacturers and AR (foreign manufacturers) must apply for medical device registration; the license is valid for five years.
Latest regulatory developments
As mentioned above, India’s transition to a mandatory registration and approval process for medical devices and IVDs is fully enforced as of 1 October 2022 for Class A and B devices and as of 1 October 2023 for Class C and D devices.
Malaysia is accepting CE marking during the EU MDR transition time. The certificates from recognized countries to support Malaysia registration shall be valid during the new registration and re-registration submission. However, due to the unpredictable timeline and issues with regards to the transition to the EU MDR, and to ensure continuous supply of the medical devices in the market, MDA has taken an approach to allow expired EC Certificate to be used for conformity assessment procedure by way of verification process with the registered CABs if the following conditions are met:
- The devices continue to comply with Directive 90/385/EEC and 93/42/EEC; and
- There are no significant changes in the design and intended purpose, and
- The devices do not present an unacceptable risk to the health or safety of patients, users, or other persons, or other aspects of protection of public health.
Additionally, the following supporting documents shall be provided for conformity assessment by way of the verification process:
- A formal letter from the national competent authority that has granted a derogation from the applicable conformity assessment procedure and/or
- A confirmation letter issued by the notified body stating the receipt of the manufacturer’s application for conformity assessment and the conclusion of a written agreement prior to the expiration of the certificate and/or
- An audit report as evidence that the manufacturer has put in place a quality management system in accordance with the MDR; and/or
- A declaration letter was issued by the notified body stating the delay in the issuance of a new certificate.
India and Malaysia are interesting markets for manufacturers because regulatory approvals such as CE marking, or FDA approval can be leveraged for fast-track market access. The conformity assessment for registration requirements is not as demanding as in other jurisdictions, the approval timeline is not long, and costs are reasonable.
How can we help?
Qserve is happy to support you in compiling the required documents and registering your devices as needed. Our global registrations team will help you register your medical devices in Australia, New Zealand, and other countries. Please contact us if you need any help.
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Are you curious about the details of market access to India, Malaysia, Australia, and New Zealand?
Watch our On-Demand recorded Free Webinar: Medical Device Registration Asia-Pacific II (hosted September 2023).
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On-Demand recording | Free Webinar Asia-Pacific Part I | China and Singapore (hosted June 2023).
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*GHTF: Global Harmonization Task Force