CMS MedTech

28/04/2022

Medical Device Registration in Singapore

(message from HSA)
Dear Stakeholders

As announced in December 2021, the Health Sciences Authority (HSA) will be revising the regulatory fees for health products*.

With effect from 1 July 2022, a fee increase averaging 3% will be implemented, with a minimum increase of $1 and capped at $200 per fee item (see List of revised regulatory fees https://www.hsa.gov.sg/docs/default-source/gdo/revised-fees-2022.pdf).

The revised fees will apply to the respective applications submitted on or after 1 July 2022.

Health Products Regulation Group
Health Sciences Authority

* Regulatory fee for health products include registration, licensing, notification and permit issuance fees for therapeutic products, medical devices, Chinese proprietary medicines, cosmetic products, oral dental gum and retail pharmacies

25/04/2022

Medical Device Registration in Malaysia

FIRST EDITION GUIDANCE DOCUMENT MDA/GD/0061: CLASSIFICATION OF REHABILITATION, PHYSIOTHERAPY AND SPEECH THERAPY DEVICE is out. Please visit MDA website for more info.

06/04/2022

REMINDERS TO THE ESTABLISMENT OF PARTIES CARRYING OUT MEDICAL DEVICE IMPORTATION ACTIVITIES: SCREENING AND INSPECTION AT THE MAIN ENTRANCES TO CURB THE IMPORTATION OF MEDICAL DEVICES WITHOUT A LICENSE AND REGISTRATION AND AUTHORIZATION

The Medical Devices Authority (MDA) would like to remind that the screening and inspection of the importation of medical devices carried out at the main entrances of the country is one of the mechanisms carried out to curb the importation of medical devices without a valid license, registration or authorization . MDA would also like to remind that the imported medical devices must be registered and imported by a licensed establishment as provided in sections 5(1) and 15(1), Medical Devices Act 2012 (Act 737) or obtain any approval issued by MDA.

In this regard, any establishment or parties involved in the importation of medical devices are reminded to provide the relevant documents, such as license certificates, registration certificates, approval letters, notification letters, letters of authorization or other relevant documents to avoid disruption to the importation and discharge of medical devices through the country's entrances.

MDA would also like to remind any party or establishment found guilty of breaching sections 5(1) and 15(1) of Act 737 may be liable to a maximum fine of RM200,000 or imprisonment for a maximum term of 2 years or both as provided in sections 5(2) and 15(2), Act 737. Any party or establishment concerned is also reminded to always comply with the license and registration requirements or conditions for any approval issued by the MDA and comply with the instructions issued by the MDA from time to time. Failure to comply with the conditions of the license is a violation of section 19(1) of Act 737, and may be liable to a fine not exceeding RM100,000 or imprisonment for a term not exceeding 1 year or both as specified in section 19(2), Act 737 while a breach of the conditions for any approval issued by the MDA may result in the approval granted being withdrawn.

29/03/2022

New Announcement on Covid-19 Self Test Kit Requirements in Malaysia

Conditions of Conditional Approval Letter:

Conditions:
1) The conditional approval for importation and distribution of the medical device listed in Appendix 1 is valid for one year.
2) An establishment given the conditional approval shall—
i) collect data related to safety and performance of the medical device and shall submit the report to the Authority on a regular basis or when it is required by the Authority;
ii) submit any information requested by the Authority within the prescribed period;
iii) comply with any directions issued by the Authority from time to time;
iv) comply with labelling requirements stipulated in Sixth Schedule of the Medical Device Regulations 2012, in particular instruction for use and disposal method, including using infographic, to make it easily understood by lay persons;
v) provide suitable and adequate storage to ensure proper conservation of the medical device in accordance with the manufacturer’s instruction;
vi) perform inspection on the primary packages of the medical device and any breached packages shall be disposed off appropriately;
vii) distribute the medical device only to licensed community pharmacies and healthcare institutions and they may sell the medical device online subject to appropriate distribution method specified by the manufacturer;
viii) establish adequate precautions and control to prevent deterioration or damage of the medical devices up until the point of use;
ix) ensure the delivery of medical devices adhere to the conditions specified by the manufacturer;
x) provide documentation of all medical devices supplied to customers, the quantity supplied, the batch or lot number and/or model and serial number;
xi) establish and maintain an appropriate distribution records up to retail distribution of the medical device to the end-user;
xii) keep the record of delivery transactions as the proof of supply of the medical device to customers;
xiii) dispose off medical device in accordance with regulatory requirements and any other applicable statutory requirements; and
xiv) not carry out any secondary assembly activities on the medical device unless the manufacturers instruction states otherwise;
3) All information pertaining to this medical device including all supporting documents shall be kept at the premises and shall be made available upon request by the Authority.
4) An establishment shall establish and maintain a post-market surveillance system to monitor the traceability of the medical device throughout the supply chain.
5) The Authority reserves the right to make a visit or inspection to the establishment at any time without prior notice.
6) The Authority may revoke the conditional approval or may take legal action should the establishment fails to comply with any conditions imposed by the Authority.

29/03/2022

https://www.mda.gov.my/announcement/906-new-announcement-on-covid-19-self-test-kit-requirements.html

Official Portal of Medical Device Authority (MDA) Malaysia

23/03/2022

Medical Device Registration in UK

Reminder:
UKCA marking is required after 1st July 2023.

11/03/2022

Medical Device Registration in India:

Reminder:
All Class A and Class B devices need to be registered under the Notified Pathway in India by September 2022.

05/03/2022

https://www.channelnewsasia.com/singapore/singapore-art-kits-not-affected-us-fda-advisory-flowflex-biosensor-hsa-2539696

SINGAPORE: Singapore's supplies of COVID-19 antigen rapid self-test (ART) kits under two brands - SD Biosensor and Flowflex - are not affected by the US health authorities' adviso

02/03/2022

Medical Device Registration in India

Reminder

All Class A and B Non-Notified Medical Products which are currently under the Mandatory process must be converted to the Notified Process by October 2022. To ensure continuity of the license, manufacturers should plan to submit the documents by March 2022 as it takes about 6-9 months to obtain approval. Non-Compliance may result in hindrance in your sales activities in India.

01/03/2022

Medical Device Registration in Colombia

29/01/2022

https://cmsmedtech.com/medical-device-registration-in-malaysia/

MedC@st 2.0 Plus System is back with advanced features that facilitate the applicants to experience better.
The new features are including with: –
i. New Change Notification module, will allow (a) Combination Category 2 and Category 3 in an application for SINGLE submission ID number and (b) Combination Category 2 and Category 3 in an application for MULTIPLE submission ID numbers (for a same risk-based classification). For more information click the link below:

Medical Device registration in Malaysia

29/01/2022

https://cmsmedtech.com/covid-19-medical-device-registration-in-malaysia/

TRANSITION OF CONDITIONAL APPROVAL APPLICATION AND SPECIAL ACCESS NOTIFICATION TO THE REGISTRATION PHASE THROUGH ONLINE APPLICATION (MEDC@ST) FOR COVID-19 TEST KIT Since the outbreak of COVID-19 in Malaysia, the Medical…