Drug Registration Updates in Indonesia

In November 2017, the National Agency of Drug and Food Control (NADFC) of Indonesia officially launched the latest version of ‘The Procedure and Guideline For Drug Registration”, which takes into consideration recent changes in both the local and ASEAN regulatory environment.

On November 24th, 2017, the National Agency of Drug and Food Control (NADFC) of Indonesia officially launched the new version of “The Procedure and Guideline For Drug Registration”, which is also known as the “brown book”. This “brown book” was changed in order to adapt to changes in both the local and ASEAN regulatory environment. Feedback was sought from the NADFC through regulatory groups such as the IPMG (International Pharmaceutical Manufacturer Group), the IPRG (International Pharmaceutical Regulatory Working Group), and the FKR (Registration Communication Forum). This approach was used by the NADFC to ensure that this new version of the “brown book” has captured all user requirements.

Several changes have been made since the first version launched in 2011. This is the history of the changes:

1) 2011: first version
2) 2013: first amendment to simplify registration requirements
3) 2016: second amendment involved the following changes:

4) 2017: third amendment

2018-02-28T18:35:20+08:00 January 29th, 2018|News & Events|

New Procedure for the Application of a Variation of the Certificate of Product Registration for Medical Devices in the Philippines

With the issuance of the FDA Circular no. 2017-014: New Procedure in the Application of a Variation of the CPR for Medical Devices on December 15, 2017, there have been improvements in the procedure for filing such applications, enabling the FDA of the Philippines to improve the efficiency of evaluations.

The Republic Act No. 3720 (Food, Drugs and Devices and Cosmetics Act), as amended by RA no: 9711 (FDA Act of 2009), was enacted to establish an effective regulatory system for the authorization, registration, and monitoring of health products in the Philippines.

Section 5 of RA no: 9711 mandated the Philippine FDA to issue certificates of compliance with technical requirements to serve as the basis for the issuance of appropriate authorization and spot-checks of the operations of manufacturers, importers, exporters, distributors, wholesalers, drug outlets and other health product establishments for compliance with regulations. The Philippine FDA issues a Certificate of Product Registration (CPR) for health products prior to their importation and distribution within the country.

If any changes or variations have been made to a product and to the issued CPR, the manufacturer or distributor is required to file a variation application with the authority. With the issuance of FDA Circular no. 2017-014: New Procedure for the Application of a Variation of the CPR for Medical Devices, issued December 15, 2017, the procedure for filing such applications has improved, enabling the Philippine FDA to improve the efficiency of product evaluations.

Scope and details of FDA Circular No: 2017-014

The filing of the application shall be guided by FDA Circular no: 2016-010. However, the new procedures in the application for a “variation of medical device product registration” to be implemented by the Licensing and Registration Division of CDRRHR shall be as follows:

1. The applicant can file for only one (1) variation application in a single transaction, regardless of the number of issued Certificates of Product Registration (CPR). The nature of changes that shall be considered are as follows:

  • Change of legal manufacturer, exporter and manufacturer provided that the name and address of the legal manufacturer, exporter and manufacturer are the same for all CPRs to be amended
  • Change of importer and distributor
  • Change of location and/or address of importer and distributor
  • Change of address of manufacturer
  • Change and/or addition of sterilization site
  • Change of label design
  • Change of instruction for use (IFU)
  • All other changes which are the same or uniform with the issued CPRs

2. The fees and charges shall be computed based on the number of CPRs to be amended.
3. The list of all CPRs to be amended shall be submitted using the FDA-specified format (both in pdf and word format).
4. The applicant shall be informed of the approved changes in the form of letter. This shall be applied to all variation applications received from 22 July 2016 onwards.
5. All approved changes shall be reflected in the CPR during the renewal of the product registration.
6. The company may request that the CPR is re-issued to reflect all the changes in the CPR upon payment of the re-issuance fee.
The said Circular shall take effect fifteen (15) days upon the issuance date.

Source:
FDA Circular No: 2017-014: New Procedure in the Application of Variation of CPR for Medical Devices

2018-02-27T11:41:57+08:00 January 29th, 2018|News & Events|

Implementation of CorpPass for HSA E-services in Singapore

All business entities in Singapore are advised to register for a CorpPass account by Q3 2018 to prevent service disruption, as CorpPass will eventually replace Singpass for all business transactions.

CorpPass is a corporate digital identity for businesses to perform online transactions with government agencies. It has been progressively implemented by various government sectors since September 2016 and will eventually replace SingPass for all business transactions.

CorpPass has been available since May 2017 to access HSA E-services in PRISM/MEDICS. All business entities are advised to register for an account by Q3 2018 to prevent service disruption. More information can be found at www.corppass.gov.sg. There is also a monthly briefing session, which you can register for here.

If your company has an existing Client Registration and Identification Service (CRIS) account with HSA – an E-Service that allows companies to authorise their employees or service providers to access HSA E-services in PRISM/MEDICS on their behalf – the administrator will need to set up a user account for you to activate and log in to PRISM/MEDICS via CorpPass.

If your company does not have CRIS account, you may apply online here. Please note that this application can only be submitted by a CorpPass Administrator. It will be approved upon submission. For further enquiries, you may email HSA at HSA_CRIS@hsa.gov.sg.

2018-02-27T11:41:37+08:00 January 29th, 2018|News & Events|

Ear wax products are classified as medical devices in Thailand

The Ministry of Public Health in Thailand does not allow the manufacture, importation or sale of ear wax products, which are classified as medical devices to protect consumers from injury.

The Gazette 24 January 2561, Ministry of Public Health, Thailand.

The Ministry of Public Health has announced that the manufacture, importation or sale of ear wax products, which are now classified as medical devices, is prohibited in Thailand to protect consumers from injury. The use of molten wax products (ear candle) is associated with fire, burns, loss of hearing or damage to the ears. The term “Medical Device” has been included in sections 4 (5) and 6 (11) of the Medical Device Act B.E. 2551. The wording is as follows:

1″The Ear Candle” is a product that looks like a candle, or any other fireproof material that can be inserted in the ear. It is intended to be used to melt the ear wax and remove the ear wax from the ear canal.

2. “The Ear Candle” is a medical device and its production, importation, and sale in Thailand is prohibited.

2018-02-27T11:41:21+08:00 January 29th, 2018|News & Events|

End-Year Temporary Shutdown of the Indonesian Medical Device Registration System

A temporary shutdown of the Indonesian medical device registration website is scheduled yearly. This year the site will be closed for maintenance from December 18th, 2017 until January 15th, 2018. During this time it is not possible for medical device manufacturers or local distributors to register new products.

Every year, the Ministry of Health of Indonesia sets up a scheduled temporary shutdown for its medical device online registration website. According to the Ministry of Health, the temporary shutdown of the website is used for maintenance and development of the medical device registration and healthcare product registration systems. Medical device applicants, either distributors or local manufacturers, will not be able to register any new products during this time. Any existing product inquiries can still be processed by either the applicant or the evaluators. The temporary shutdown happens at the end of the year and the system is reopened after 30 calendar days. This year (2017-2018) the registration system will be closed from December 18th, 2017 and will be accessible again on January 15th, 2018.

2018-01-08T17:26:07+08:00 January 3rd, 2018|News & Events|

IVD scheme in Vietnam: Two systems of regulation for 2018 period

For the 2018 period, the registration of in-vitro diagnostic medical devices shall comply to Circular 44/2014/TT-BYT and the importation shall follow Circular 47/2010/TT-BYT until 31 Dec 2018. Therefore, in 2018, there are two regulatory systems for medical devices in Vietnam for Class B,C,D devices, including the IVDs.

The Vietnamese Government has issued Decree No. 36/2016 /ND-CP on management of medical equipment on 15th May 2016. Following this, a more stringent and comprehensive legal framework for medical devices has been introduced. These include implementation of risk based classification system and ensuring all devices to have a circulation registration numbers to be marketed in the country.

Since 15th May 2016, Vietnamese Government has issued the Decree No. 36/2016 /ND-CP on management of medical equipment. The Decree provided a systemic management in every aspect of medical device. These include implementation of risk based classification system and ensuring all devices to have a circulation registration numbers to be marketed in the country.

Also in 2016, the issuance of the new Pharmacy Law 105/2016/QH13, on 06 April, 2016 in which no longer mention of In vitro Diagnostic medical devices (IVD). That means, IVDs are now considered as medical devices which are under controlled by the Department of Medical Equipment and Construction (DMEC). Before the issuance of the new Pharmacy Law, IVDs are under controlled of DAV (Drug Administration of Vietnam) and the application dossier is similar to drug registration dossier previously.

However, on 06 December 2017, MOH of Vietnam issued the Dispatch no. 7165/BYT-TB-CT on Implementation of Resolution 131/NQ-CP on 06 Dec 2017 for the extension of the approval for Class B,C,D medical devices product license due to some incompletion in implementation of the new regulation (Decree 36/2016/ND-CP). All the product license of medical devices Class B,C,D submitted to DMEC have to wait until 01 January 2019 to get the product license, including the IVDs. For the 2018 period, the registration of in-vitro diagnostic medical devices shall comply to Circular 44/2014/TT-BYT and the importation shall follow Circular 47/2010/TT-BYT until 24:00 31 Dec 2018. Therefore, in 2018, there are two regulatory systems for medical devices in Vietnam for Class B,C,D devices, including the IVDs.

2018-01-08T17:27:15+08:00 January 3rd, 2018|News & Events|

Press Release by Medical Device Authority Malaysia: Another Registration Extension

High requests and demands from the medical device industry led MDA to grant another registration extension until 30th June 2018 (applicable to applications during transition period). After this date, only the licensed establishment certificate and the medical device registration certificate are acceptable as supporting documents to import and distribute devices in Malaysia.

Surprise, surprise – the planned full enforcement of medical device registration requirements as specified under Section 5 of the Medical Device Act 2012 (Act 737) has now been extended again from 31st December 2017 until 30th June 2018. This extension is applicable to the registrations that were submitted during the transition period i.e. before 30th June 2016, which were accompanied with acknowledgement letters issued by MDA to allow devices to be marketed and distributed regardless of registration status of devices.

According to the press release by Medical Device Authrity, the extension is granted due to high requests and demands from the medical device industry who needs more time to complete their applications. After 30th June 2018, only the license establishment certificate and the medical device registration certificate are acceptable as supporting documents in the procurement process of medical devices in any health facility institution and also distribution of devices in the country. The acknowledgement letters are no longer valid for use as a supporting document after this date.

The press release is in Bahasa Malaysia and can be viewed here.
You can also read our article on previous extension granted until 31st December 2017 here.

2018-01-08T17:28:00+08:00 January 3rd, 2018|News & Events|

Registration Extension in Vietnam: Resolution 131/NQ-CP

Due to various reasons from regulators and industries as well as to considering the continuous supply of medical devices in the country, the Ministry of Health decided to delay the full implementation of Decree No. 36/2016/ND-CP for medical device class B,C,D another year to 1 Jan 2019. The extension can be referred in Resolution 131/NQ-CP.

The Vietnamese Government has issued Decree No. 36/2016 /ND-CP on management of medical equipment on 15th May 2016. Following this, a more stringent and comprehensive legal framework for medical devices has been introduced. These include implementation of risk based classification system and ensuring all devices to have a circulation registration numbers to be marketed in the country.

To initiate the implementation, the authority has started to receiving registration of Class A medical device starting 1 Jan 2017 and Class B, C and D starting 1 July 2017. Subsequently starting 1 Jan 2018, all medical devices shall have a circulation registration number in order to be marketed locally.

However, due to various reasons including from regulators and industries as well as to considering the continuous supply of medical devices in the country, the Ministry of Health is now delay the full implementation of Decree No. 36/2016 /ND-CP for medical device class B,C,D another year to 1 Jan 2019. The extension can be referred in Resolution 131/NQ-CP. With the extension, medical devices can still be circulated as per Circular No 30/2015/TT-BYT where import license as per Circular No 30/2015/TT-BYT will still be valid.
For Medical Devices Class A: the implementation shall follow Decree 36.
For Medical Devices Class B, C, D which including the list of medical devices required import license, according to Circular no. 30/2015/TT-BYT on 12 Oct 2015, continue to be imported as per Circular 30.

For Medical Devices Class B, C, D which does not belong to the list of medical devices required import license, have to present the classification result as per regulation, until 24:00 31 Dec 2018.

The registration of in-vitro diagnostic medical devices shall comply to Circular 44/2014/TT-BYT and the importation shall follow Circular 47/2010/TT-BYT until 24:00 31 Dec 2018.
Companies whose import license expired on 31 Dec 2017, will be allowed to submit the extension of the import license.

(Reference: Dispatch no. 7165/BYT-TB-CT on Implementation of Resolution 131/NQ-CP on 06 Dec 2017)

2018-01-08T17:28:27+08:00 January 3rd, 2018|News & Events|